Texas on track to become first state to explicitly back stem cell … – STAT

L

awmakers in Austinhave approved a billauthorizing unapproved stem cell therapies, puttingTexas on track to become the first state to explicitly recognize the experimental treatments.

The measure now heads to Governor Greg Abbott, who has signaled his support for it.

For years, clinics across the country have been offeringexperimentalstem cell therapies for patients with chronic conditions or terminal illnesses, but no state has given them legal validation. Instead, clinics have largely operated under the radar of regulatory authorities, toutingtreatments for a range of injuries and diseases.

advertisement

Many scientists, meantime, have warnedthat unapproved stem cell therapies can be not only ineffective but harmful outside limited and closely watched clinical trials.

Infant gets experimental stem cell injection to try to repair his heart

The Texas measure was finalized Monday before the end of the Legislatures session. Senators added amendments that would require the treatments to be delivered by a doctor at a hospital or ambulatory medical center and with the approval of an institutional review board, which reviews research that involves human participants. Another amendment would allow patients to sue should the treatment go awry.

Advocates who opposed the measure as it was introduced said they were still uneasy with aspects of it, but that they hoped the amendments would add protections for patients.

If the legislationbecomes law, it will go into effect Sept. 1.

Meanwhile, two other measures focused on patient access to experimental therapies often called right-to-try policies failed in the Texas Senate after being approved by the House.

One would have aligned Texass right-to-try laws with similar statues in almost three dozen other states by allowing clinics to charge for unapproved treatments. Texas is the only state that bans patients from paying for investigational therapies, according to the Goldwater Institute, a libertarian think tank that supports many right-to-try laws.

A separate measure would have pushed Texass right-to-try law beyond the others. It would have expanded statelaw so that people with chronic conditions not just patients with terminal conditions could access experimental treatments. In Texas and every other state, the statutes limit access to patients with terminal illnesses, although the definitionof those conditions varies from state to state.

Andrew Joseph can be reached at andrew.joseph@statnews.com Follow Andrew on Twitter @DrewQJoseph

Trending

Accidental therapists: For insect detectives, the trickiest cases involve

Accidental therapists: For insect detectives, the trickiest cases involve the bugs that arent really there

With womb transplants a reality, transgender women dare to

With womb transplants a reality, transgender women dare to dream of pregnancies

Can we cure aging? Scientists disagree

Can we cure aging? Scientists disagree

Recommended

Quickly reporting cancer complications may boost survival

Quickly reporting cancer complications may boost survival

Nevada governor vetoes bill that targeted diabetes drug costs

Nevada governor vetoes bill that targeted diabetes drug costs

U.S. could save $825 million a year with a

U.S. could save $825 million a year with a small change in immunotherapy dosing, study says

Read the original post:

Texas on track to become first state to explicitly back stem cell ... - STAT

MS patients await governor’s signature on bill allowing adult stem … – WOAI

by Michael Locklear, News 4 San Antonio

Stefanie Cowley of Helotes testified in favor of the bill. She was diagnosed with multiple sclerosis in 2007, was told she was a no-option patient in 2011 and in 2014, she began the therapy that required her to travel to Mexico. (Photo: Sinclair Broadcast Group)

SAN ANTONIO Some terminally and chronically ill patients are eagerly awaiting the governors signature on a bill they believe will help thousands of Texans.

HB 810, known as Charlies Law, would allow access to adult stem cell therapy for certain sick people.

Stefanie Cowley of Helotes testified in favor of the bill. She was diagnosed with multiple sclerosis in 2007, was told she was a no-option patient in 2011 and in 2014, she began the therapy that required her to travel to Mexico.

Cowley said a Houston company, Celltex Therapeutics, does a mini-liposuction, extracting a few tablespoons of her fat, then prepares the hundreds of millions of stem cells. She then travels to Cancun so a private hospital there can set up an hour-long IV to return the stem cells to her body.

These are your healing cells, she said. These are if you cut yourself, they're your healing cells that go towards that spot to repair.

That took my pain levels down from 8-9-10 daily to 2-3-4, Cowley said.

Charlies Law would presumably allow her to access the treatment entirely within Texas, which could become the first state in the country to do so.

Cowley said other conditions such as Parkinsons, Alzheimers and even autism could benefit from the treatment, although stem cell researchers caution that large-scale successes have not yet been reported.

David Eller, CEO and Chairman of Celltex Therapeutics, released the following statement:

@MichaelLocklear | mlocklear@sbgtv.com

Originally posted here:

MS patients await governor's signature on bill allowing adult stem ... - WOAI

Stem-cell therapy is poised to disrupt the Tommy John epidemic in baseball – Quartz

For about half a decade, its been something of an open secret in baseball that playerspitchers especiallyregularly undergo stem-cell therapy to stave off surgeries and lost playing time. Its a cutting-edge medical procedure, done by everyone from high-school standouts to major-league all-stars. Its rarely discussed by players, or by their coaches, parents, doctors, or employers.

So when the Los Angeles Angels went public in 2016 with the news that first Andrew Heaney and then Garrett Richards were undergoing stem-cell therapy for torn ulnar collateral ligaments (UCLs), it was both anticlimactic and a revelation. For the first time, baseball pitchers and their employers were openly admitting trying this novel procedure that, while fairly well-proven anecdotally, has yet to be validated by any well-designed scientific study.

By now, that so-called Tommy John surgery for a torn or damaged UCL has become a rite of passage for the top-flight professional baseball pitcher is a cliche of sports punditry. Every young arm that can fold and then unfold itself into tortuous patterns that facilitate throwing baseballs at 95 miles per hour or faster is bound for the knife, once those upper body contortions inevitably tear the tissue on the inside of their elbows connecting their upper and lower arms, the UCL.

The first Tommy John surgery (or more properly, UCL reconstruction) was performed in 1974 by the orthopedic surgeon Frank Jobe, then the team physician for the Los Angeles Dodgers, on the eponymous pitcher. It was a great success; Tommy John came back to pitch 14 more years in the pros, racking up 164 wins with four different teams.

TJ surgery is fairly straightforward: the connective tissue that makes up the UCL is either replaced with a tendon taken from elsewhere in the patients own body or from the donated tissue of a cadaver.

Nevertheless through the mid-1970s and into the 80s, TJ was something of a rarity; just a handful of baseball players underwent that particular knife. In the 1990s the numbers started to tick up, and then in the 2000s, they exploded. From 1995 to 2005, there was an average of 28 TJ surgeries per year across all levels of pro baseball; from 2005 to 2015, there was an average of 84 TJ surgeries per year.

Then something strange happened. In 2016, the total number of TJ surgeries performed dropped to 90, from 127 the year before, a 30% decline. Only one other year in Tommy John history, 2008, saw such a precipitous drop from the previous year. By 2009, TJ numbers were back to 2007 levels; obviously it remains to be seen whether 2017 will look more like 2015 or more like last year. But the data suggest that if TJ surgery numbers are in fact starting to trend downward, it might have something to do with the rise of stem-cell therapy.

What makes stem cells unique is that they are whats called undifferentiated; they can become other specialized cells depending on the bodys need at the time. There are two types of human stem cells, embryonic and adult. Embryonic stem cells come from a very early-stage embryo; these are what you likely think of when you hear the term stem cellstheyre at the center of one of most exciting fields of medical science research today. Embryonic stem cells are now used or are being studied for a shockingly wide range of applications, from Alzheimers and autism to vision impairment and infertility. However, thanks to the religious right-driven opposition to the harvesting, study, and use of embryonic stem cells, theyve been mired in controversy in the US.

On the other hand, the use of adult stem cellswhich can be harvested from bone marrow, fat, or blood of any person of any age (the name is a bit misleading)is widely accepted by both the medical community and politicians. They have less range, so to speak, than embryonic stem cells; they are primarily to repair and replace damaged tissue in the area they are found. That makes them just about perfect for repairing a torn UCL.

The first pro baseball player known to have undergone stem-cell therapy for a UCL weakness was Bartolo Colonand he was basically forced into talking about it. Following a long run of success culminating with a Cy Young Award season in 2005, Colon had four frustrating years racked with injury and ended up unsigned after 2009. He took a year off to recuperate and in spring of 2011, he was back, signed with the New York Yankees and feeling good. Serge Kovaleski, an investigative reporter with the New York Times, started digging into how Colon had made his comeback, and uncovered the name of Joseph Purita, an orthopedic surgeon and stem-cell therapy pioneer.

As Purita tells it, there was nothing illegal or nefarious about the work hed done on Colon; there was just never a plan to broadcast it, either. Then, he recalls, the Times called me up and said were going to write a story whether or not. So, Purita offered details. In April 2010, he told the paper, a team of Dominican doctors used stem-cell therapy to help repair Colons ligament damage and torn rotator cuff.

Colons recovery was a resounding success. Hes been an all-star twice, is the current active leader in major league wins, and, at age 44, is signed to a $12.5 million contract to be the Atlanta Braves number two starter for the 2017 season.

I cant give names but there are some professionalsBut instead of thrusting stem-cell therapy into the mainstream, the Colon incident forced it to stay underground. The treatment was not well understood at that point, and the circumstancesthat it was done offshore, that it was unearthed by investigative reporting, and that, in 2012, Colon was suspended for 50 games for testing positive for testosterone useclouded public opinion on it. Many were convinced Colon had gotten performance-enhancing drugs in the Dominican Republic. Purita denies this vociferously, and MLB inquiries back him up.

The upshot is that every doctor I spoke to who studies and performs stem-cell therapy for torn-ligament repair says some version of the same thing: I cant give names but there are some professionals who have come in for treatment, says Joshua Dines, an orthopedic surgeon at New Yorks Hospital for Special Surgery, and an assistant team physician for the New York Mets.

Purita says that since Colon, hes worked with some players that had team approvaland some just come on their own, but none wanted to go public about the procedure.

If use of your arm is mostly limited to spreadsheet jockeying and lifting forkfuls of pasta or salad from plate to maw, TJ is no big dealin that case, youre ready to go back to work in six weeks. But if you throw a ball at top speed past another pro athlete for a living, youre going to be out of commission for 18 months or more as you regain strength in your money arm.

And money is the (post) operative word. In 2016 alone, MLB teams lost nearly $60 million in player value because they had to fulfill dozens of contracts of players recovering from Tommy John. Thats nearly enough to field an entire pro teamdefinitely enough to roster a top-of-league pitching staff. And that $60 million doesnt come close to accounting for the losses suffered by players who had to undergo the knife during the last year of a contract, and found themselves released by their previous teams with no new offers on the table while they recovered.

There was never going to be a way to prevent the need for Tommy John surgeries. Baseball players throw far too hard, with far more breaking pitches, starting at far too young an age, to realistically stop UCLs from tearing (though all sports medicine experts do now warn coaches and parents to keep kids and teens at low pitch counts). The alternative was always going to be something that could cure ligament tearsbut better than TJ surgery, with a faster recovery time.

Everything weve seen in the past decade or so suggests stem-cell therapy is exactly that. At this point, platelet-rich plasma (PRP) injections are common first-line defenses against UCL injuries. The procedure entails harvesting PRP from the player and injecting it into the injured part of the body. PRP is dense with proteins specialized for injury repair.

You can think of these injections as a precursor to stem-cell therapy; both are considered biologic treatments and entail wielding the bodys own weapons against injury. Many of the doctors now doing stem-cell therapy started off with PRP procedures. When baseball players have a torn ligament, they typically try PRP first. If that fails, its Tommy John time.

Everyone in the field says that at this point PRP is last decades technologyExcept, everyone in the field says that at this point PRP is last decades technology, more than ready to be replaced by stem-cell therapy, which does much the same thing but better. Adult stem cells essentially are there for the very purpose of tissue repair. Why not take them from a part of the body thats all good, and send them to a region where reinforcements are desperately needed?

Dines says that in his own practice, hes been able to cut down the need for Tommy John surgery by about a third, thanks to his reliance on stem-cell therapy. He doesnt believe that the procedure will lower the number of players that have to have TJ, but it will limit the number of overall TJ surgeriesbecause at this point, many pitchers have to get the surgery twice in their career. Dines says stem-cell therapy can get 15- or 16-year-old pitchers through their first partial tear. They may still need to get a full TJ surgery by age 24, but avoiding that first one is still a huge victory. (A growing number of middle-age first-time TJ patients could also explain the overall drop in Tommy John surgeries.)

Purita is even more optimistic. While most orthopedic surgeons say that, right now, stem-cell therapy is effective on partial, but not full, ligament tears, Purita is confident his version can handle any UCL. He sent Quartz a photo showing a patientan MLB pitcher who wishes to remain anonymous, Purita sayswho had a full UCL tear in November 2011 and, after receiving stem-cell therapy at Puritas clinic, made a full recovery by February 2013.

You never say something replaces something else entirely, Purita says. Stem-cell therapy is not going to replace every case [of Tommy John], but it could probably replace the majority of cases.

Talk to anyone who knows the field and theyll rattle off the same reasons why stem-cell therapy for UCL tears isnt already the standard of care: One reason is that, relative to the population, the number of UCL tear patients is extremely small, which means theres only a tiny pool from which to draw potential study participants. Two, a trial for a new medical treatment is typically only considered well-designed if the subjects are blindthat is, they dont know if they are getting the real treatment or a placebo. But what kind of team or player is going to risk a million-dollar arm on a properly designed study where theres a 50% chance that the injury gets a placebo?

Thats not to say that this is some sort of back-alley procedure. Its performed by some of the most prestigious orthopedic surgeons and medical research centers in the US, and the US Food and Drug Administration approves its use: US doctors are allowed to harvest a persons stem cells and use those cells to treat that same person, as long as you dont manipulate (e.g. genetically modify) the cells.

Someone making $20 million a year is not going to do something he hasnt checked out wellThe lack of literature on the procedure hasnt exactly inspired the confidence of players and teams to go public with their decision to pursue it; nor does the fact that the procedure for years had, as Dines puts it, a bad rap[it] would get lumped in with things that were illegal. There was this specter of cheating. But Dines, and others, say thats changing.

The needle is moving towards this being a valid way of treating things, says Purita. People are starting to recognize that someone making [or risking] $20 million a year is not going to do something he hasnt checked out well.

Amadeus Mason, a sports medicine and biologics expert at Emory University, compares stem-cell therapy today to Tommy John in the 1980s. It was, Okay, were going to try this and see, says Mason, who trained with orthopedic surgeon James Andrews. (Andrews is the Michael Jordan of ligament repairhes saved the arms and careers of some of the greatest pitchers in major league baseball history.) There wasnt a big fanfare going in when players started with Tommy John surgeries, Mason says, but when players came back to pitch [there] was. Same thing here.

Mason thinks stem-cell therapy hasnt quite reached the inflection point, but it is near. Here, too, he sees a comparison with Tommy John: It took a while for them to perfect the procedure so that more and more doctors could do the surgery and reproduce the results well.

Right now, Mason says, there is a relatively small handful of doctors who can do stem-cell therapy for UCL tears, but that list is growing rapidly. For example, the annual conference of the Orthobiologic Institutea professional organization for regenerative medicine researchers and practitionersstarted in 2009 with 20 or so doctors; last years event had nearly 1,000.

Some players can throw faster after they have the surgeryThe Angels didnt want to talk to me about why they decided to go public with Heaney and Richards stem-cell therapies. Perhaps thats because Heaneys, on May 2, 2016, was unsuccessful. The 25-year-old former first-round draft pick underwent Tommy John surgery in July of that year after failing to regain strength in his left arm. Hell miss the entire 2017 season, setting back a promising young career.

Richards had his stem-cell procedure just 14 days after Heaney. So far, it seems to have worked. He didnt return to pitch in 2016, but in spring training this year, he was throwing nearly 100 miles per hour. Probably the Angels best starting pitcher, Richards will take the mound on April 5, and all eyes will be on his right throwing armand on his face, to see if it is registering any pain.

If Richards stays healthy this yearand next year, and the year after thathe could become something like the 21st-century Tommy John. Every team will have a stem-cell therapy expert on its medical staff, or at least one on speed dial. Careers will be saved, and so will millions of dollars.

But wider use of stem-cell therapy also will force the MLB to confront an interesting potential side effect of the procedure. Some players can throw faster after they have the surgery, says Purita. By definition, its making the performance better. Right now, major league baseball does not include stem-cell therapy in its list of banned performance enhancers (pdf). But what happens when a baseball player, perhaps a fringe pitching prospect in the low minors, feels some elbow pain one day and gets an MRI, and is diagnosed with nothingbut decides to get stem-cell therapy anyway, since it could give him an extra four miles per hour on his fastball?

The MLB will have a decision to make: To accept potential competitive imbalances to save young arms, or to seek to preserve a level playing field (or even just the fiction of one) at the cost of some of the games best players. The question is all but inevitable.

See the rest here:

Stem-cell therapy is poised to disrupt the Tommy John epidemic in baseball - Quartz

Study: heart failure stem cell therapy safe, shows early signs of effectiveness – The San Diego Union-Tribune

A stem cell treatment for heart failure patients is safe and shows early signs of effectiveness, according to a study published Wednesday.

The study was conducted by Japanese researchers in 27 patients, who received transplants of stem cells taken from their own thigh muscles. There were no major complications, and most patients showed considerable improvement in their symptoms.

The study was published in the open-access Journal of the American Heart Association. Dr Yoshiki Sawa of Osaka University Graduate School of Medicine was the senior author. It can be found at j.mp/stemheart.

However, two San Diego cardiologists who do stem cell research on heart disease cautioned that similar clinical trials have shown promise over the years, only to fail at the end for various reasons. There is no approved stem cell therapy for heart failure.

So while the trial itself appears to be well-conducted, the researchers are very far from actually proving their treatment is effective, said Dr. Richard Schatz of Scripps Health and Dr. Eric Adler of UC San Diego School of Medicine.

For one thing, the trial was small, they said, and larger trials are where the most rigorous scientific evaluations are made.

These early trials have looked beneficial in the past, Adler said. When we do the larger trials, the results are more equivocal.

Adler said the signs of efficacy in this trial are modest. For example, the change in ejection fraction, a measurement of efficiency in pumping blood, rose from 27 percent to 30 percent in 15 of the 27 patients. Their heart failure was associated with a lack of blood flow, or ischemia. The remaining non-ischemic patients actually had a slight decline.

The entire field of stem cell and regenerative therapy for heart disease has been a disappointment to date, Schatz said.

Weve been at it for 20 years now, and we dont have a product or a positive (late-stage) trial, so that tells you pretty much everything you need to know, he said. Its not for lack of trying or billions of dollars invested. Its just very, very difficult.

The cardiac field has had more success with other technologies, such as cardiac stents. Schatz is the co-inventor of the first stent.

In the study, the researchers acknowledge that previous attempts had only been modestly effective. They devised a method of producing sheets of muscle stem cells and attaching them to the inner layer of the sac that encloses the heart, a layer that rests directly on the heart surface.

The stem cell sheets stimulate healing by producing chemicals that stimulate cardiac regeneration, the study said. The cells themselves dont survive in the long term, but by the time they die they have served their purpose.

Loss of function

Heart failure is a progressive disease in which the heart gradually loses its ability to pump blood. This can be triggered by a heart attack or any other cause that damages the heart muscle.

When damaged heart muscle is replaced with scar tissue, as often happens, the heart loses pumping capacity. It becomes overstressed, and its output of blood declines. This limits the patients ability to engage in intensive physical activity. In advanced cases, patients may become bedridden.

Existing treatments include drugs and LVAD units, which take over some of the hearts function to relieve stress. Some drugs may help the heart work more efficiently, but none have been shown to improve heart failure by actually regenerating lost heart muscle.

Stem cell therapy is tested in patients who havent responded well to other treatments. Trials have been and are being conducted in San Diego area hospitals.

Scripps Health has been testing a cardiac stem cell therapy from Los Angeles-based Capricor. The cells, taken from donor hearts, are injected into the coronary artery, where they are expected to settle in the heart and encourage regrowth.

UC San Diego is testing a heart failure therapy from Teva Pharmaceutical Industries. It consists of bone marrow derived mesenchymal precursor cells. These can give rise to several different cell types, including muscle cells.

And many other trials are going on throughout the country and internationally.

Adler and Schatz said theres reason for optimism in the long run, as technologies improve.

Just because the other trials have been negative doesnt mean this technique wont be beneficial, Adler said. Its just too early to tell.

That said, Schatz emphasized that the nature of the three-phase clinical trial process means that the show-stoppers for a treatment typically appear late.

Tighter standards needed

Clean trials trials where we all agree that this is the patient population we want to look at, are needed, he said.

For example, heart failure comes in two types, he said. Ischemic heart failure is caused by heart attacks and blocked arteries, which impede blood flow. Non-ischemic heart failure can be caused by damage from diseases, such as a virus.

Non-ischemics can be younger people, in their 20s and 30s, while the ischemic patients are older. Mixing those patient groups in a single trial is a mistake, he said.

Theyre different animals, Schatz said.

Another pitfall is failing to screen carefully enough to enroll only patients likely to benefit, Schatz said.

You can have a patient who has chest pain, and coronary disease just incidentally, he said.

His shoulder or chest pain is from a virus. So he goes into the trial and gets a placebo injection in his arm of cortisone, and his arm pain goes away. And because hes in that placebo group, hes counted as a success the pain went away. It has nothing to do with his heart. Thats an extreme example, but we actually saw that happen.

In a failed gene therapy trial for heart disease, some patients apparently had received the injection in the wrong location, missing the heart muscle, Schatz said.

You assume they got the gene, but they didnt, Schatz said. The study was negative, and thats why I think it was negative.

Such errors dont show up in Phase 1 trials, Adler and Schatz said, because theyre focused on evaluating safety. And these early trials dont have many patients, there arent enough to comfortably determine the therapy is really effective.

By the last stage of the trial, these sources of error have often been identified and trial standards have tightened up. And thats when the faulty assumptions made early appear as the trial ends in failure.

Despite those forbidding hurdles, Adler said research should continue.

This disease is killing a lot of people. Theres not going to be enough hearts to go around for transplant. Theres six million Americans with heart failure, and theres 2,000 heart transplants a year. So coming up with novel regenerative cell-based therapy is something were still excited about.

bradley.fikes@sduniontribune.com

(619) 293-1020

Original post:

Study: heart failure stem cell therapy safe, shows early signs of effectiveness - The San Diego Union-Tribune

Stem Cell Therapy for Autism Shows Promise – WebMD – WebMD

April 6, 2017 -- A stem cell treatment for autism shows promise, according to a new study, but the investigators and other experts emphasize that the therapy is still in the early stages and much more research is needed.

The Duke University study included 25 children, ages 2-6, with autism and assessed whether a transfusion of the youngsters' own umbilical cord blood containing rare stem cells would help treat their autism, CNN reported.

Behavioral improvements were reported in 70 percent of the patients, according to the study in the journal Stem Cells.

A second, larger trial is now underway and the researchers hope they will find a long-term treatment for autism, CNN reported.

Some experts say many unanswered questions remain and the study authors agree much more work needs to be done. This initial trial was a safety study, meaning doctors and the children's families knew the therapy was being administered and there was no comparison between treated and non-treated children.

"Some children, who were not speaking very much, had big increases in their vocabulary and their functional speech," study author Dr. Joanne Kurtzberg, head of the Robertson Clinical and Translational Cell Therapy Program, told CNN.

"Many children were able to attend to play and have meaningful communication in a way that they weren't before. Some children had less repetitive behaviors than they did when they came onto the study," Kurtzberg said.

"The study was very encouraging. We did see positive results. However, it did not have a comparison group, which is very important in establishing whether a treatment is actually effective," study author Dr. Geraldine Dawson, director of the Duke Center for Autism and Brain Development, told CNN.

WebMD News from HealthDay

Read this article:

Stem Cell Therapy for Autism Shows Promise - WebMD - WebMD

Stem cells offer hope for autism – CNN

It wasn't always so. Just a couple years ago, Ryleigh, 11, was scared of her sister when she'd throw tantrums and screaming fits.

"She would've fought and kicked," Ryleigh says, noting that it wouldn't have been possible to sit like this next to Gracie.

Gracie, 7, interrupts: "I don't even remember it."

"We do," says her mother, Gina Gregory.

Gracie has autism, a condition that affected nearly every aspect of her family's life after she was diagnosed at 2. But a new study is offering hope for the Gregorys and families like them.

The results were impressive: More than two-thirds of the children showed reported improvements. A larger second trial is underway, one its researchers hope will lead to long-term treatment for children with autism.

But for the Gregorys, the change in their daughter has been monumental.

Gone are the days of Gracie throwing fits in long lines at Disney World or during dinner at restaurants. When a tantrum intruded on family outings, her mom and dad wished they had T-shirts that said "My kid has autism" to ward off judgmental stares.

During autism therapy sessions, Gracie would kick, scream, spit and hit at her occupational therapist. "It was horrible to try to get her to sit there," her mother says.

Even just brushing her teeth or combing her hair could set her off.

Gracie, then 5, was on the mild to moderate autism scale, but her parents say the disorder consumed about 75% of their daily routine. After her participation in the study, that figure has been reduced to a mere 10%.

On a scale of 1 to 10, they rate her improvement around an 8 or 9; it's been that dramatic. She's even begun attending a "regular" school and thriving there, something her parents never thought possible. She'd been in various specialized school programs, and nothing was the proper fit.

Are Gracie's changes a result of the cord blood transfusion stimulating her brain? Or did her brain just mature as she got older? Could it be that her parents were subconsciously determined to magnify her improvements, given all their family had been through?

Those are questions the Gregorys still ask. But they do know that their daughter's transformation appeared to begin about six months after her transfusion in January 2015 and has continued ever since.

Her father's favorite adjustment is her newfound affection. Instead of shunning hugs, she now welcomes an embrace.

"We will say we don't think it's cured her. You still see some of the small idiosyncrasies that she does have," says her father, Wade Gregory. "But again, I think it's supercharged her learning curve. It's pushed her to do things she normally wouldn't do."

Her mother adds, "She got better, and we're just thankful for that -- whether it be the stem cells or not. We're just thankful for what changes have happened."

Each unit is designated by labels with specially designed adhesive to withstand extremely cold temperatures for decades. There are 14 cord blood freezers in all.

It is the cord blood in those freezers -- stored or donated by parents in case a serious illness develops -- that's at the cutting edge of this research.

About 30% never learn to speak, and many children even with early behavioral interventions still struggle to adapt. There also are no FDA-approved medications that improve the core symptoms of autism.

"I was very interested in collaborating with people here at Duke who could offer medical approaches that could enhance neuroplasticity, or the brain's ability to respond to treatment," Dawson says.

"We've been able to show that with some of these diseases, a cord transplant rescues them from death and also improves their neurologic outcome," she says.

She began wondering: Could cord blood help other children?

About a decade ago, her laboratory began clinical tests of children with cerebral palsy whose parents had banked their cord blood. Again, they saw positive results. And in some of those children who had autistic tendencies, they saw autistic symptoms improve. Another spark went off: What if they tested cord blood specifically for autism?

The safety trial began a little over a year and a half ago. Not only did it find cord blood to be safe, but 70% of the 25 children, age 2 to 6, had behavioral improvements as described by their parents and tracked by the Duke researchers. The research is largely funded by a $40 million donation from the Marcus Foundation, a nonprofit created by Home Depot co-founder Bernie Marcus.

The children traveled to Duke three times over the course of a year. They underwent a series of evaluations such as autism assessments, MRIs and EEGs to track their brain activity. On the first trip, the children received the cord blood infusion along with the intense evaluations. Each child received 1 billion to 2 billion cells, given through an IV in their arms or legs. At six months and then a year later, the children returned for more tests and observations.

"Some children, who were not speaking very much, had big increases in their vocabulary and their functional speech," Kurtzberg says. "Many children were able to attend to play and have meaningful communication in a way that they weren't before. Some children had less repetitive behaviors than they did when they came onto the study."

Adds Dawson, "The study was very encouraging. We did see positive results. However, it did not have a comparison group, which is very important in establishing whether a treatment is actually effective."

Both researchers can't stress that enough: that although they're cautiously optimistic about the results, they want the science to play out. They are now in the midst of the definitive trial on whether cord blood can treat autism -- a double-blind, placebo-controlled trial involving 165 autistic children, ranging in age from 2 to 8. The FDA has oversight of the study.

During the phase II study, the children on their first visit receive a cord blood infusion -- either their own or from a donor -- or they get a placebo. They also undergo a battery of assessment tests and brain monitoring.

On their second visit six months later, the children receive a second infusion with whatever preparation they did not receive the first time and undergo more evaluations. The order of the infusions is not known. Researchers will monitor them for the next year for any sign of behavioral improvements.

It's known as a crossover trial, in which each subject gets the treatment and the placebo but in a different order. Researchers say it would have been nearly impossible to find participants if parents knew that their children might not receive an infusion.

How groundbreaking would it be if the trial shows similar results to the safety study?

"If we can show that receiving an infusion of cord blood is more effective for improving social behavior than the placebo," Dawson says, "then this will be game-changing."

Kurtzberg adds, "We'll be extraordinarily encouraged if the second trial shows that the cells benefit children when the placebo does not. We will consider that a breakthrough."

Both researchers were shaped early in life by the struggles families face raising autistic children. As a teen, Dawson babysat twins with autism who lived across the street. "It was just an inspiration to devote my career to improving the lives of people with autism," she says.

Kurtzberg was similarly affected. When she was a junior in college, she would visit a girl with severe autism and play with her as a means of behavioral intervention. "The family still writes to me," she says.

It is for this reason -- their longtime devotion to families raising children with autism -- that both issue a heap of caution. Although they're excited about the results of the first study, Kurtzberg says, "we don't want to mislead people and claim it's working before we have definitive proof."

Adds Dawson, "It's important for parents who might hear about cord blood as a potential treatment for autism to know that we are working very hard to know the answer to that question. We aren't there yet."

Kurtzberg has a hypothesis about what may be happening: that certain immune cells within the cord blood are crossing the blood-brain barrier and altering brain connectivity while also suppressing inflammation, which may exist with autism.

"I feel more confident now because of our (cerebral palsy) study, which preceded this study and does show benefits," Kurtzberg says.

"One has to be very careful when interpreting results that haven't come from properly controlled, double-blind studies," he said. "All I can say is that it would be wonderful if this treatment was effective, but one has to be very cautious before reaching any conclusions."

Even without a placebo effect, he says, many factors could have resulted in an improved outcome in the first study: The growing children could have acquired skills simply through maturation, possibly enhanced by occupational therapy, and their parents may have clung to positive gains, creating a biased outcome.

Kriegstein of UCSF also wonders whether cord blood is really stimulating cells in the brain and creating new connections. "There are so many unanswered questions about what might be going on here, it becomes very difficult to evaluate the proposed mechanism," he said.

"The question remains: How do these cells injected intravenously wind up in the brain, how do they target the appropriate brain regions, and what are they doing that could improve brain function?"

An 8-year-old boy with autism sits at a table in a room within Duke's Center for Autism and Brain Development. Clinical research specialist Michelle Green watches from behind a two-way mirror. Two cameras in the room feed computer monitors, allowing her to further analyze his behavior.

Dr. Lauren Franz, a clinician, works with the boy in the room.

"What kind of things make you feel threatened or anxious?" she asks.

"Like when I'm done with a test," the boy says.

"How does it feel when you're frightened or anxious? How does that feel?"

"Like pretty weird," he says.

The boy is participating in the second trial, and he's returned for his six-month assessment and second infusion. Researchers don't know which infusion he received first: the cord blood or the placebo.

But they track, record and monitor the slightest of details. Although it might seem like an innocuous conversation, researchers will compare the results with those of his first visit and any follow-ups. Was he able to sit still at the table before? Could he articulate his thoughts? Did he talk before the study? Has he improved?

At the Gregorys' home in Florida, Gracie's parents remember when she went through those same tests. The best investment they ever made, they say, was the $2,000 spent on banking her cord blood. At the time, it was just a precaution; her autism diagnosis didn't come until three months after her second birthday.

They know the desperation of families raising a child with autism -- of longing for their daughter to have a shot of normalcy in life. "You can't quantify it. You can't measure it. You want to see your child succeed," her father says.

Mom and Dad recently watched old home videos, of Gracie singing inaudibly, of her covering her ears when "Happy Birthday" was sung for her third birthday, of showing no emotion on Christmas when she was 2. "I forgot how bad it was," her mother says.

They hope the current study leads to similar successes -- and results in breakthrough treatment for autistic children everywhere.

See more here:

Stem cells offer hope for autism - CNN

The risks of unproven stem cell treatments – Radio New Zealand

An expert in stem cell treatment is warning of dodgy operators in New Zealand offering unproven and potentially dangerous treatments.

Auckland University Medical School lecturerBronwen Connor's warning comesafter arecently-released scientific paper documented a case of three women in the United States who were blinded by an experimental treatment for macular degeneration.

She said many people had stem cell therapy in the belief it was scientifically valid, but that was not often the case.

Dr Connor told Nine To Noon the cells used most often for the treatments were known as adipose cells, which were obtained from fat tissue in the body. They were popular because they couldbe obtained from a patientby liposuction, isolated out, then re-injected for supposed therapeutic use.

"Adipose stem cells obviously have a very important job, but predominantly their job is to make bone and cartilage. They also do have some anti-inflammatory properties. But they, to date, have not been shown to have any potential or ability to generate brain cells, for example, or new kidney cells or heart cells."

Websites for clinics offering the treatments listed up to 20 or 30 different types of diseases, disorders or conditions that one source of cells could supposedly treat. That was worrying, she said.

Adipose stem cells might be the right choice to help repair cartilage damage in the knee. "However, it wouldn't be your stem cell choice if you ... had Parkinson's disease and you were going to try and replace some of those lost cells in your brain."

Dr Connor said people needed to be sceptical and check if, for example, there hadbeen any human clinical trials involving the treatment.

"There are always dangers around treatments that we haven't taken out long-term and which there haven't been sufficient rigorous human clinical trials undertaken [on]. This is the purpose of clinical trials, to see what is the safety aspect and the efficacy of this procedure."

She advisedpeople to think about it in terms of medicines and drugs that people were used to taking, like aspirin. "If you inject yourself with a stem cell population and you have a bad side effect, you can't get those cells out. So ... we really need to know what those cells are going to do long-term and what any potential risk is, because they cannot be retrieved."

The Ministry of Health did not regulate stem cell therapy in this country because the cells were not regarded as medicine. She said it was a grey area, because cells were being taken from a patient and re-injected into the same patient with their consent. "But really, moving forward in the next 10 to 20 years, we're going to see more and more of these type of therapies that don't involve a pill or a tablet or our traditional thought of a medicine, and we really need to get regulations around that type of therapy."

She had spoken to people who paid large sums of money for the treatments.

"When I questioned them a little bit more ... did it help, they would sort of sheepishly say 'well, no not really'."

Dr Connor said clinics offering the treatments often emphasised the benefits according to the scientific literature, but it might be benefits in animals - not from human trials. She wanted quality control addressed and standardisedprocedures, along with safety and efficacy.

Dr Connor wanted to see clinical trials of many of the therapies,as they hadpotential. "Our fear is that, as with the three women with the macular degeneration, is that anything that goes wrong will really hinder the field because people will just see it as stem cell therapy."

See the original post here:

The risks of unproven stem cell treatments - Radio New Zealand

Stem Cell Therapy Market by Type, Therapeutic Application, Cell Source – Global Forecasts to 2021 – PR Newswire (press release)

NEW YORK, March 7, 2017 /PRNewswire/ -- l stem cell therapy market is estimated to grow at a CAGR of 11.0% during 2016 to 2021 to reach USD 145.8 million by 2021. Growth in the global stem cell therapy market is driven by factors such as the growing awareness of the therapeutic potency of stem cells in effective disease management, development of advanced genome-based cell analysis techniques, increasing public-private investments for development of stem cell therapies, identification of new stem cell lines, and developments in infrastructure related to stem cell banking and processing. In addition, countries such as Japan, South Korea, and China are offering new growth opportunities for players operating in this market. The North American region is expected to command the largest share in the stem cell therapy market in 2016.

Read the full report: http://www.reportlinker.com/p04759526-summary/view-report.html

Based on the type of therapy, the allogeneic stem cell therapy segment is estimated to command the larger share of the global stem cell therapy market in 2016. This growth can be attributed to the growing availability of allogeneic stem cell therapy products, wider therapeutic applications of allogeneic stem cells, easier production scale-up due to easy availability of sources of stem cells, and growing number of clinical trials of allogeneic stem cell therapies as compared to autologous stem cell therapies.

The stem cell therapy market is niche industry with a growing number of global and local companies involved in the development and commercialization of stem cell therapy products. Osiris Therapeutics, Inc. (U.S.), MEDIPOST Co., Ltd. (South Korea), Anterogen Co., Ltd. (South Korea), and Pharmicell Co., Ltd. (South Korea) were the leading players in the global stem cell therapy market in 2015. New product launches and approvals; expansions; and partnerships and agreements are the major strategies adopted by most of the market players to achieve growth in the stem cell therapy market during 20132016.

Research Coverage This report studies stem cell therapy market based on type of therapy (allogeneic and autologous). These stem cell therapies are used for the treatment of various diseases (including musculoskeletal disorders, wound healing, CVDs, and GI diseases, among others). The report also studies, the factors (such as drivers, restraints, opportunities, and challenges) which affect the market growth in a positive and negative manner. It analyzes opportunities and challenges in the market for stakeholders and provides details of the competitive landscape for market leaders. The report forecasts the revenue of the market segments with respect to four main regions, namely, North America, Europe, Asia-Pacific, and the Rest of the World. The stem cell therapy market report strategically profiles the key players who are involved in the manufacturing and commercialization of stem cell therapy products and comprehensively analyze their market ranking and core competencies. The report tracks and analyzes competitive developments such as new product launches and enhancements; expansions; and partnerships and agreements in the stem cell therapy market.

Reasons to Buy the Report:

From an insight perspective, this research report focuses on various levels of analysismarket share analysis of the top players and company profiles, which together comprise and discuss basic views on the competitive landscape; emerging and high-growth segments of the stem cell therapy market; and high-growth regions and their respective drivers, restraints, challenges, and opportunities.

The report will enrich both established firms as well as new entrants/smaller firms to gauge the pulse of the market, which in turn will help firms in garnering a greater market share. Firms purchasing the report could use any one or a combination of the below-mentioned five strategies (market penetration, product development/innovation, market development, market diversification, and competitive assessment) for strengthening their market shares.

The report provides insights on the following pointers:

- Market Penetration: Comprehensive information on products offered by the top 10 players in the stem cell therapy market. The report analyzes the stem cell therapy market by type, therapeutic application, cell source, and region

- Product Development/Innovation: Detailed insights on research and development activities, developmental product pipeline, and new product launches in the stem cell therapy market

- Market Development: Comprehensive information about the lucrative emerging markets. The report analyzes the markets for various stem cell therapy products across four geographies (North America, Europe, Asia-Pacific, and the Rest of the World)

- Competitive Assessment: Assessment of market shares, strategies, products, distribution networks, and manufacturing capabilities of the leading players in the stem cell therapy market

Read the full report: http://www.reportlinker.com/p04759526-summary/view-report.html

About Reportlinker ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

http://www.reportlinker.com

__________________________ Contact Clare: clare@reportlinker.com US: (339)-368-6001 Intl: +1 339-368-6001

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/stem-cell-therapy-market-by-type-therapeutic-application-cell-source---global-forecasts-to-2021-300419663.html

SOURCE Reportlinker

http://www.reportlinker.com

The rest is here:

Stem Cell Therapy Market by Type, Therapeutic Application, Cell Source - Global Forecasts to 2021 - PR Newswire (press release)

Stem Cell Therapy – painreliefcenterstx.com

At Neuropathy & Pain Centers of Texas, non-invasive medical procedures are the mainstay of our practice. Using the most up to date techniques, our staff treats patients as whole people, providing a comprehensive diagnostic assessment in order to design a customized strategy for relief from medical concerns in the Dallas/Fort Worth area. The technology has advanced to a point that, at Neuropathy & Pain Centers of Texas, we apply stem cell treatments designed to help our patients attain their wellness goals and achieve a higher quality of life.

For instance, until recently, treatment options for people with osteoarthritis of the knee were limited. Steroid injections, joint replacement surgery, and physical therapy were often the only treatment options. Now, regenerative injections for knee osteoarthritis are available at Neuropathy & Pain Centers of Texas. Regenerative cellular therapy also has applications for treating Achilles tendonitis, rotator cuff tendonitis, and degenerative arthritis.

These injections work with the bodys natural ability to heal itself. Unlike treatments that simply address the symptoms, stem cell therapy actually promotes repair of the body, restoring degenerated tissue. Stem cell injections also contain hyaluronan, which eases pain and restores mobility by lubricating joints and tendons. This therapy fits well with Neuropathy & Pain Centers of Texass integrated approach to wellness, addressing the source of issues, rather than just treating the symptoms.

See the original post:

Stem Cell Therapy - painreliefcenterstx.com

Stem Cell Therapy receives FDA Boost to enter the US Market – Labiotech.eu (blog)

TiGenix has receivedpositive feedback from the FDA on an improved global phase III trial protocol for its lead candidateCx601 for Crohns disease. This is expected tospeed up US approval.

TiGenix is a Belgian companydevelopingstem cell therapies. The biotech is currently pushing its lead candidateCx601to the market for the treatment ofcomplex perianal fistulas in Crohns disease patients. Cx601 recently revealedpositive resultsin a European phase III study.

Following these results, the company submitted a number of technical adjustments for itspivotal phase III study for Biologics License Application (BLA) in the US, which were now approved by the FDA and are expected to acceleratethe process to US marketing authorization.

TiGenix is wellknown for its productChondroCellect, which was the first cell therapyto reach approval on the European market for the repair of knee cartilage.After the companyrecently withdrew its market authorization for this product, due to a lack of reimbursement, the biotech is focusing on its new leadCx601.

Thisproduct, currently awaiting EMA approval, consists ofallogeneic expanded adipose-derived stem cells (eASC), which are indicated for the treatment ofperianal fistulas in Crohns disease. The therapeuticeffects of eASCs are based on immunomodulatory abilities of these stem cells, which canrestore immune balance by suppressing a variety of immune cell subsets and inducing the generation of regulatory T cells.

Areas of the colon commonly affected duringCrohns disease

The current approval from the FDA will allow TiGenix to file the BLAbased on the efficacy and safety follow-up of patients at week 24, instead of week 52.The FDA has also agreed to accept fewer patients than originally planned in the study and endorsed a broader target population that will ultimately facilitate the recruitment process.

We believe that this revised protocol will allow us to file for approval one year earlier than we had originally plannedconcludedMaria Pascual, VP Regulatory Affairs & Corporate Quality of TiGenix

The current amendments will allow TiGenix to push its therapyto the US market even faster, which might pivotal for the company in light of its financial situation. After its shares had reached a low of22 cents back in 2013, the share price is currently still under 1. Withits low 34M IPO on Nasdaq in the end of last year, its market cap is stillonly at 191M. A low sum for a late stage clinical company.

As the EMAapproval forCx601 is expected soon, which will then be commercialized by Takeda, the company may actually be underestimated. The biotech recently started a new Phase Ib/IIa trial to testCx611 as a treatment for sepsis in patients with pneumonia.

Asecond platform consisting of transplanted allogeneic cardiac stem cells (AlloCSC)is currently in Phase II for acute myocardial infarction. It seems like TiGenix is definitely clinging toits position as one of the pioneers in stem cell-based therapies.

Images via shutterstock.com / CI Photos and CC 3.0 /RicHard-59

Originally posted here:

Stem Cell Therapy receives FDA Boost to enter the US Market - Labiotech.eu (blog)

Hospital group invests $20M in stem cell therapy biotech – FierceBiotech

Hospital group Sanford Health has invested $20 million in InGeneron to support clinical trials of a stem cell regenerative medicine. The Series D gives Sanford a financial stake in an adipose-derived stem cell therapy it is testing in a clinical trial at its network of healthcare facilities.

InGeneron began working with Sanford on an 18-person trial of its stem cell injection in patients with partial thickness rotator cuff tears around the turn of the year. And the network of 45 hospitals and close to 300 clinics has now tightened its ties to InGeneron by investing $20 million in the Houston, TX-based regenerative medicine company. InGeneron sees benefits in strengthening its relationship with Sanford.

This significant investment demonstrates Sanfords commitment to be an active participant in InGeneron as well as being our clinical trial site of choice. Our joint efforts will enable the company to make regenerative cell therapies available to clinical practice and to establish a leading position in the application of adipose-derived regenerative cells, InGeneron President Ron Stubbers said in a statement.

Sanford runs the two trial sites that are enrolling patients in the aforementioned 18-person trial. Both sites specialize in orthopedics and sports medicine. Rotator cuff injuries are associated with overhead sports, such as baseball and tennis. The healthcare system is presenting its close involvement with InGeneron as a positive for the patients it serves because it facilitates early access to an experimental therapy.

The treatment entails processing adipose tissue harvested during liposuction to create a mixture containing stem cells and nutrients. This mixture is injected into the site of the injury. In the trial, one-third of participants will form a control arm and receive a cortisone injection instead of stem cells.

The exec team tells FierceBiotech that the first patients were enrolled in the feasibility trial for rotator cuff tendinopathy in January, with U.S. regulatory market approval "anticipated in 2020."

InGeneron last raised money last year through a $4.5 million seed round. That financing, which came 10 years after InGeneron was founded, followed studies of the companys cell therapies in knee surgeries. InGeneron also makes biomedical equipment for collecting and processing adipose tissue.

The biotech has and its subsidiaries on both sides of the Atlantic has a team of 30 people, and has raised $38 million to date.

Read more from the original source:

Hospital group invests $20M in stem cell therapy biotech - FierceBiotech

Stem Cell Therapy An Option For ENC Patients | Public Radio East – Public Radio East

Stem cell therapy is a quickly advancing treatment being used across the country. Now, its becoming more prevalent in eastern North Carolina to those living with chronic pain an alternative to surgery. The minimally invasive procedure is showing results in alleviating back, knee, hip and shoulder pain. Though stem cell therapy is classified by the Food and Drug Administration as experimental, patients say theyre finding relief. Meet New Bern resident and a local endodontist Dr. Donnie Luper. He was skeptical of the procedure at first.

How did you know what those stem cells were going to differentiate into? I mean was I going to grow a foot out of my shoulder or something like that?

Luper tore his rotator cuff 25 years ago during a tubing incident on the Trent River. A subsequent fall during a golf trip in 2015 sent him to a specialist.

I went to see a shoulder surgeon in Richmond. He told me that he didnt think it was a complete tear of my rotator cuff, that I could probably have a minor surgical procedure done and I asked him about stem cell.

After talking with a friend who opted for stem cell treatment for her knee pain, Luper decided to find out more.

My option was if I would have had that shoulder surgery and they had do that bicep tendon repair, I mean I would have been in a sling for six weeks and probably not working for three months.

According to the Food and Drug Administration, stem cells sometimes called the bodys master cells - have the ability to divide and develop into many different cell types. Each new cell has the potential to remain a stem cell or become another type of cell, such as a nerve cell, a skin cell, or a red blood cell. They may also help repair the body by dividing to replenish cells that are damaged by disease, injury or normal wear. Parkinsons disease, spinal cord injuries, damaged organs and cancer could all be possibly treated with the use of stem cells, but more research is needed. Dr. Angelo Tellis is the owner/physician of Aegean Medical, which provides stem cell therapy to patients in Cary, Jacksonville, Morehead City and New Bern.

The adult stem cells we call multipotent stem cells so they can only differentiate into very specific or certain kinds of tissue. Whereas the embryonic stem cells we call pluripotent and can become a variety, almost any tissue. But I only deal with adult stem cells, theyre found to be more useful in clinical applications.

Dr. Tellis says adult stem cells are more responsive to growing tissue in very specific locations. When patients go into Dr. Tellis office for the two hour procedure, he starts by numbing an area of the abdomen and performing liposuction to collect one or two syringes of body fat.

Stem cells can be found in a lot of different tissues throughout the body, but theyre actually in one of the highest concentrations in your own body fat.

The stem cell sample is combined with platelet rich plasma or PRP collected through a blood draw.

That has a lot of the chemical signals and messengers that activate stem cells. So Ill typically combine that with some of the stem cells collected from the body fat and then go under x-ray guidance and put it exactly in the targeted location where we want to create that healing process.

Soreness and stiffness can be expected immediately following the procedure and for about a week after. Dr. Tellis says the results tend to improve with time, taking about three to six months for full recovery. This was Lupers experience in 2016.

Really didnt have to take any pain medications. The joint was really sore over the weekend just because of the injection of the fluid there and after that, I had a small amount of discomfort, but nothing I really had to take medication for.

After three months, Luper says he felt 90 percent better. But he decided to get a second opinion from a shoulder surgeon.

And he told me he thought the stem cells had done a lot but that I still had one little bone spur that was rubbing against the muscle and constantly tearing the little bit of the muscle.

After surgery, Luper says his left shoulder started feeling significantly better in about a month. He was also able to return to one of his favorite pastimes golf. While surgery helped eliminate all of his pain, Luper believes stem cells helped regenerate tissue that was damaged years ago.

He said my rotator cuff muscle didnt even look like it had been torn. I actually tore that, Im sixty now, and I actually tore that when I was 34, 35 tubing on the river and I had to do physical therapy for about three months, but he said he saw absolutely no evidence that Id ever had a rotator cuff tear.

Even though some have found relief and possibly a cure through stem cell therapy, the Food and Drug Administration has not approved any stem cell-based products for use, other than HEMACORD (HE-muh-cord). According to their website, the use of stem cells raises safety concerns such as excessive cell growth, the development of tumors as well as cells migrating from the site of administration and differentiating into inappropriate cell types. And then, theres the cost of the procedure, which is not covered by insurance. The price for the treatment ranges from $2,500 to $5,000. But for those who want to avoid major surgery and the downtime associated with recovery, the risk and cost may be worth it.

If Id have surgery, my deductible would have been that because I have an out-of-pocket max. And I would want to do anything to avoid surgery, especially something that would keep me out of work for three months.

The FDA recommends that consumers interested in stem cell therapy should start a conversation with their doctor about the potential risk to benefit ratio. In addition to Aegean Medical, Advanced Health and Physical Medicine in Greenville and Regenerative Medicine Clinic of Wilmington also provide stem cell therapy in eastern North Carolina.

Visit link:

Stem Cell Therapy An Option For ENC Patients | Public Radio East - Public Radio East

Is Alzheimer’s treatment of injecting stem cells into the brain a breakthrough or quackery? – The Mercury News

More than eight years after he realized something was wrong, after, as he described it, My brain went

Whats the word? Foggy, Jack Sage finally said after several seconds of silently coaxing his synapses to fire.

More than eight years after his brain went foggy, four years after he was diagnosed with Alzheimers disease and two years since he began an innovative and extremely invasive therapy, Sage said he is being flooded by memories that seem new, or, at the very least, feel easier to retrieve. His daughter, Kate, thought Sage had suddenly begun to open up about his past because he knew his time was growing short.

He should not know who I am at this point, Kate said.

His doctor, Christopher Duma, hopes Jack Sage goes down in history as the one-man turning point in the treatment of Alzheimers disease, while others are skeptical about what Duma has done to Sages brain. Everyone agrees that Alzheimers disease is an exploding problem.

The California Alzheimers Disease Data Report from 2009 projected a 67 percent increase between 2015 and 2030 in residents in Los Angeles, Orange, Riverside and San Bernardino counties living with Alzheimers disease up to 498,137. The same report references a study, between 2000 and 2004, in which 58 percent of the deaths among people 65 and older in California were attributed to Alzheimers disease. New numbers will be released Tuesday.

The Alzheimers Association reported that 610,000 Californians 65 or older had the disease in 2016, and it estimated increases to 690,000 by 2020 and 840,000 by 2025.

On a cool recent night, Sage, a handsome, fit, 82-year-old, sat next to his wife Gloria talking about his children (It is significant that Sage remembers their names James, 46, Kate, 50, and Kelly, 56), recalling when he and Gloria moved into the Newport Beach house with a view of the Pacific Ocean (1990), laughing about their first date at the Bel-Air Country Club (1979), recounting his years as a labor negotiator and executive for Del Monte, Allied Chemical and Continental Airlines (1970s and 60s) and going all the way back to the jack hammering he did in the nickel mines (mid-1950s) in Northern Ontario, Canada.

At this point in his illness, his doctor said he should be having more trouble remembering the perilous tunnels of the Sudbury nickel mine.

You drill into the granite, Sage said. You put dynamite in the rock. You dynamite it. Then you shovel out whats left.

And mining, you might say, is what is happening in Jack Sages brain.

Sages series of recollections, including his exploits on the golf course in Indian Wells where he has a second home and plays several days a week flashbacks representing the three main components of long-term memory: semantic (recalling the meaning of words), episodic (recalling autobiographic milestones) and procedural (recalling how to accomplish tasks) prompted a grin from Duma, the brain surgeon who, for $10,000 per treatment and without insurance coverage, cut a hole in the back of Sages head and injected a stem cell serum that had been sucked out of Sages love handles.

Is this the Alzheimers breakthrough the world has been waiting for? Or, is this unproven medical procedure what University of Minnesota bioethicist Leigh Turner calls quackery and flimflam? Is this an unsafe, money-grab it is being conducted outside the approval process of the Food and Drug Administration preying on the most vulnerable among us?

Turner has written extensively and critically about the Cell Surgical Network (CSN), for which Duma, whose home hospital is Hoag in Newport Beach, is listed as a network physician. The CSN promotes the stem cell revolution, which its literature claims, is an appropriate treatment for people suffering from a variety of inflammatory and degenerative conditions in other words, for cancer, diabetes, bad knees and hips as well as multiple uses in cosmetic surgery.

You dont just start dumping things into peoples brains, Turner said. The problem is people may spend a lot of money and find there is no benefit. He (Duma) is exposing people to serious harm. Fat cells dont belong in peoples brains.

Sage is the first patient in Phase I of a clinical study officially called Intracerebroventricular injection of autologous abdominal fat-derived, non-genetically altered stem cells. Sage was the first Alzheimers patient anywhere to have his own liposuctioned cells injected directly into his brain. He has received eight injections (about two months apart) since November 2014.

Duma quickly offers a qualifier. It is far too early to tell if what he has done to Sage will indeed change the world. He said Sage and, later, 19 other patients have not been harmed by the procedure, and that safety is the only criteria in Phase I. Whether the treatment is effective is a question for Phase II, for which Duma is hoping to attract private funding. Also, he wrote a letter to the national Alzheimers Association asking for $700,000 to continue his work. He was instructed to apply officially later this year. If he gets the grant, the fees for his patients would be waived.

Early in the process, Duma is excited by Sages results.

Sages most recent cognition scores have risen from 45 on the 100-point Memory Performance Index in March 2015 to 54 in September 2015. The volume of his hippocampus the memory center of the brain has grown from the fifth percentile before his first treatment to the 28th percentile after his fourth treatment to the 48th percentile after his eighth treatment.

My golf game is getting better, said Sage, who, heart permitting, plays several times per week. Sages brain isnt his only problem. He has a long history of heart ailments that have required the insertion of 12 stents to keep his arteries open.

You cant make a global conclusion based on one patient, but its a huge turning point, Duma said with the confidence of someone who probes brains for a living.

Duma is somewhat of a maverick in the medical world, a brain surgeon who regularly shuns a scalpel for the gamma knife, a futuristic laser for removing brain tumors. He is known outside the operating room for playing keyboards in bands that specialize in 1970s-era covers of groups such as Genesis, Yes and Emerson, Lake and Palmer. As a child, he was a classmate of John F. Kennedy Jr. at The Browning School in New York City. We called him John John, Duma said.

Duma realizes he will face opposition to his stem cell/brain injection therapy. But, as in all breakthroughs, someone has to be first.

I could have harmed people, he said. I took an enormous leap.

Not much hope

Alzheimers patients dont get better.

They get diagnosed, lose their dignity and die.

The speed at which death occurs is the only variable.

In the depressing world of Alzheimers treatment, Sage and Duma represent equal parts hope and skepticism. The Orange County Register contacted universities and research centers across the country, including Stanford, Harvard, Duke, Florida International, UC Davis, and some of the interview requests were denied while other calls were not returned. Very few medical experts want to talk about the combination of stem cells and Alzheimers disease, apparently because they know so little about it.

An Alzheimers patient improving because of therapy? Im hopeful its true. Im hopeful its true for all patients, said Joshua Grill, the co-director of the Memory Impairments Neurological Disorders (MIND) institute at UC Irvine. We are in dire need.

But, Grill continued, One study does not a revolution make. Ive never read anything about this (Dumas work), and I dont know what science is behind it.

Dean Hartley, Director of Science Initiatives at the Alzheimers Association, knew about Dumas work.

This is new territory, Hartley said. But with one patient, No, you cannot say this is a game-changer.

Hartley said many studies fail at the Phase II level, where more and more people are exposed to the therapy.

Still, Hartley said Dumas work is encouraging.

We want to see things like this happen, Hartley said.

Its not as if Duma is conducting his research in secret. He spoke about his study in public forums twice last year Sept. 28 at the Congress of Neurological Surgeons in San Diego, and Oct. 1 at the International Society for Cellular Therapy in Memphis.

Duma said he is nearly finished writing a paper about his work that he hopes will be published in a peer-reviewed journal.

The stem cell idea

In 1993, Christopher Duma was working at Good Samaritan Hospital in Los Angeles when he and his colleagues began injecting stem cells into the brains of patients with Parkinsons disease. They were making some progress, he said, but politics intervened. Some of the stem cells they were using came from aborted fetuses. Pressure from anti-abortion groups shut that program down.

Fifteen years later, Duma was assisting plastic surgeon Michael Elam on a face-lift on a Parkinsons patient when Elam said, We need to talk about stem cells.

Elam introduced Duma to Drs. Mark Berman and Elliot Lander, the founders of the Cell Surgical Network.

Berman and Lander had been separating stem cells from fat by using a centrifuge (which they own the patent for) and injecting them into knees and hips and other places where injuries had occurred. Their work had passed an Institutional Review Board after 1,524 patients were treated with no adverse effects, Berman said.

If you want to repair an injury, Berman said, the best tissue is the stem cell.

In 2013, Duma suggested a new target for stem cell therapy: the brain.

Duma, with Berman, Lander and Elam as co-authors, tried to begin a study of brain/stem cell injections. But their first attempt at Institutional Review Board approval was denied because they hadnt done animal testing. So they got Dr. Oleg Kopyov at Cal State Northridge to conduct tests on rats.

With the help of Kopyovs work, Duma got Institutional Review Board approval. They chose not to take the usual next step FDA approval.

The Institutional Review Board was expecting us to go through the FDA, Lander said. But there are hundreds of obstructions. The FDA approval process usually takes between eight and 12 years, according to the online journal Medscape.com.

Duma said stem cells present a quandary for the FDA because stem cells are not a drug, and theyre not food. Clinics that take stem cells out of the body and put them back in without additives argue that they are exempt from FDA mandates.

We have been harvesting fat from abdomens and putting them in the brain during brain surgeries since the 1920s, Duma said. We do it nearly on every case for pituitary tumors, acoustic and skull base tumors and for conditions of spinal fluid leakage since the 1920s. If the FDA ruled that harvested autologous fat cannot be used in the brain, then it would change nearly a century of neurosurgical standard of care.

Someday, Duma said he hopes the FDA will recognize his work.

The work cant wait, he said.

The brave one

In August 2013, Jack Sage staggered into the office of Dr. William Shankle in Newport Beach.

Shankle, a renowned expert in cognitive disease he is the author of the Memory Performance Index that is used around the world diagnosed Sage with two problems: Alzheimers disease and hydrocephalus (fluid on the brain). Sage needed a shunt in his brain to drain the fluid and relieve the pressure.

So Shankle walked him down the hall (their offices are yards apart on the same floor in the same building) and introduced Sage to Christopher Duma, medical director of Hoag Hospitals Brain Tumor Program, and the surgeon who would put in the shunt.

Duma remembers that first meeting. Sage was in straight-line cognitive decline, Duma said.

Shankle would not grant an interview about Duma or his treatment. Shankle said he is wary of hocus pocus about Alzheimers disease without saying that Duma has done anything wrong. More than a decade ago, Shankle tried a surgical stem cell therapy on patients. He removed patients stem-cell-rich omentum, a fatty sheath covering the abdomen, cut open their skulls and stretched the omentum directly on their brain. Four of the six patients he studied had serious complications from the surgery.

The patients improved in cognitive tests, but the surgery was too much for them.

The method of delivering the treatment was radical (surgical transposition of the greater omentum to the surface of the brain while keeping the blood supply intact), Shankle wrote in an email. After showing that it really works, my goal was to never do the surgery again but find a different way of delivering these critical factors less invasively.

Sage was the patient Duma had been waiting for.

Jack was a man who was doomed, Duma said. He looked like classic Alzheimers. He had no ability to follow a train of thought. He was asking and re-asking the same questions. People like Jack are there, but theyre not there.

Sage was perfect for Duma for other reasons. He has always been a fitness nut cycling, tennis, golf, skiing and 10K runs were all part of his lifestyle. Kate Sage said he has been ordering salmon and spinach for dinner at restaurants for years.

Jack is the experimental model, Duma said. He is the brave one.

During two years of treatments, Sage has either maintained or slightly improved his cognitive health. He had a major heart attack in 2016, making his brain less of a cause for concern than his heart.

Kate said she doesnt know if Dumas treatment is working.

Its hard for me to say this is miraculous, Kate said.

She said she doesnt worry about his brain as much anymore.

Hes going to drop dead with some kind of a heart thing, she said. Hes not going to lose his memory.

Jack Sage

The tragedy of Alzheimers disease is that it not only steals the history that makes us who we are. It takes our skills, our beliefs, our independence, our ability to love.

So far, Jack Sage is still Jack Sage. Obviously, he doesnt know if he would be the same without Dumas treatments.

I can tell Im getting better and better, Sage said. Is that pure optimism? The Placebo Effect?

In January, Jack Sages drivers license came up for renewal. He said hes able to remember driving directions without problem. He still navigates the route from his home in Newport Beach to his other home in Indian Wells. But, he was required to pass the written test, and Sage feared he wouldnt be able to remember the complex rules of the road.

I was worried, he said.

But he passed, and his license was extended five years.

His improved memory, he said, sometimes catches him by surprise.

These memories come up when I dont even think about it, Sage said.

Sometimes, the memories take Sage places he doesnt want to go.

When he worked in the nickel mines in the 1950s, he and his first wife had a son.

His name was Mark, Sage said, speaking slowly as if the memory was bubbling up from depths he didnt want to consider. We rented a house with a playroom. My wife went shopping, and I was upstairs

I was working on my school work for McMaster University

Mark fell

we had a drainage basin inside the house

when I got to him, he was gone

Sage stopped talking as if flooded by new emotions over the death of his son.

We were distraught, he said. It was tough times for years.

In the murky world of Alzheimers therapy, Jack Sage is still mining.

Contact the writer: ksharon@scng.com

More:

Is Alzheimer's treatment of injecting stem cells into the brain a breakthrough or quackery? - The Mercury News

Opinion/Commentary: Global stem cell therapy market to showcase … – The Daily Progress

LONDON Technavio analysts forecast the global stem cell therapy market to grow at a compound annual growth rate of close to 37 percent during the forecast period, according to their latest report.

The research study covers the present scenario and growth prospects of the global stem cell therapy market for 2017-2021. To determine the market size, the study considers revenue generated from allogenic and autogenic stem cell therapies.

The Americas are the largest regional segment of the global stem cell therapy market, responsible for generating over 56 percent of the total revenue (2016 figures). The region is expected to continue market dominance through the forecast period, driven by increasing demand for stem cell therapy products and investments into R&D.

Technavio analysts highlight the following factors as contributing to the growth of the global stem cell therapy market:

Increase in federal funding in stem cell therapy.

Sapna Jha, one of the lead research analysts at Technavio for medical imaging research, says, Many stem cell research institutes and small companies are involved in cutting-edge R&D and are yielding encouraging results. These institutions are witnessing an increased flow of investments from federal organizations, due to the realization of the importance of regenerative medicine.

The U.S. National Institutes of Health, a major funding government organization invested approximately USD 1.5 billion in stem cell research projects in 2016. Similarly, several state-level organizations such as California Institute for Regenerative Medicine has contributed USD 3 billion to stem cell research in 2014. Such funding will help various research institutes to discover and develop regenerative medicines, which will boost the global regenerative medicine market enormously.

Growing demand for personalized medicine.

The health care sector is creating a high demand for personalized medicine, which could offer game-changing opportunities for the vendors. These medicines offer treatments based on the individual characteristics, needs, and preferences, which will vastly improve the quality of health care. Individuals are increasingly banking their stem cells for future treatments. Research organizations are also extensively exploring ways to develop personalized treatments with stem cells, which could eventually erase the conventional medicine system and help in the effective treatment of various diseases such as diabetes and cancer.

Demand for development of effective drugs for cardiology and degenerative disorders.

There has been an increased demand to develop effective drugs for cardiology and degenerative disorders, for which there were no effective treatment plans before the advent of stem therapies. The discovery of possible cardiac stem cells uncovered new arenas to repair hearts injured due to acute myocardial infarction or coronary artery disease, says Sapna.

Researchers are studying and developing approximately 19 product candidates for the treatment of cardiac disorders, with eight of them in Phase III, and six in Phase II.

Technavio is a global technology research and advisory company. This report was made available through The Associated Press.

Follow this link:

Opinion/Commentary: Global stem cell therapy market to showcase ... - The Daily Progress

Stem Cell Therapy Market Worth 145.8 Million USD by 2021 – PR Newswire (press release)

(Logo: http://photos.prnewswire.com/prnh/20160303/792302 )

Browse 60 market data Tables and 37 Figures spread through 120 Pages and in-depth TOC on "Stem Cell Therapy Market"

http://www.marketsandmarkets.com/Market-Reports/stem-cell-technologies-and-global-market-48.html

Early buyers will receive 10% customization on this report.

The report analyzes and studies the major market drivers, restraints, opportunities, and challenges in North America, Europe, Asia-Pacific, and the Rest of the world (RoW) for the forecast period of 2016 to 2021. Factors such as the growing awareness related to the therapeutic potency of stem cells in disease management, development of advanced genome-based cell analysis techniques, increasing public-private investments for stem cell research, identification of new stem cell lines, and developments in infrastructure for stem cell banking and processing are propelling the growth of the global Stem Cell Therapy Market.

On the basis of type, the global Stem Cell Therapy Market is divided into two major categories, namely, allogeneic stem cell therapy and autologous stem cell therapy. The allogeneic stem cell therapy segment is expected to command the largest share in the global Stem Cell Therapy Market in 2016. This large share can primarily be attributed to the rising commercialization of allogeneic stem cell therapy products, wider therapeutic applications of allogeneic stem cells, easy production scale-up process, and growing number of clinical trials related to allogeneic stem cell therapies.

Inquiry Details: http://www.marketsandmarkets.com/Enquiry_Before_Buying.asp?id=48

On the basis of therapeutic application, the global Stem Cell Therapy Market is segmented into musculoskeletal disorders, wounds and injuries, cardiovascular diseases, surgeries, gastrointestinal diseases, and other applications. The musculoskeletal disorders segment is expected to command the largest share of the global Stem Cell Therapy Market in 2016. This large share can be attributed to the rising availability of stem cell-based products for the treatment of musculoskeletal disorders, high prevalence of musculoskeletal disorders and bone & joint diseases, and growing patient preference for effective & early treatment strategies.

North America is expected to be the largest regional segment in the global Stem Cell Therapy Market in 2016, followed by Asia-Pacific. In addition, the North American Stem Cell Therapy Market is expected to be the fastest growing region during the forecast period. Factors such as growing awareness related to the therapeutic potency of stem cells, increasing number of clinical trials for stem cell-based products, and increasing public-private funding & research grants are driving the growth of this market.

Download PDF Brochure: http://www.marketsandmarkets.com/pdfdownload.asp?id=48

As of 2015, Osiris Therapeutics, Inc. (U.S.), MEDIPOST Co., Ltd. (South Korea), Anterogen Co., Ltd. (South Korea), Pharmicell Co., Ltd. (South Korea), Holostem Terapie Avanzate S.r.l. (Italy), JCR Pharmaceuticals Co., Ltd. (Japan), NuVasive, Inc. (U.S.), RTI Surgical, Inc. (U.S.), and AlloSource (U.S.) are some of the key players operating in the global Stem Cell Therapy Market.

Browse Related Reports:

Stem Cell Assay Market by Type (Viability, Differentiation, Cell Identification), Kit (Mesenchymal, IPSCS, Hematopoietic), Product (Flow Cytometer, Detection Kit), Application (Regenerative Medicines, Drug Development), End User - Forecast to 2021

http://www.marketsandmarkets.com/Market-Reports/stem-cell-assay-market-47610330.html

Stem Cell Banking Market by Bank Type (Cord Blood, and Cord Tissue), Service (Collection & Transportation, Analysis, Processing, and Storage), Application (Cerebral Palsy, Leukemia, Thalassemia, Anemia, Autism, Diabetes), Region - Forecast to 2021

http://www.marketsandmarkets.com/Market-Reports/stem-cell-banking-market-220680183.html

About MarketsandMarkets:

MarketsandMarkets is the largest market research firm worldwide in terms of annually published premium market research reports. Serving 1700 global fortune enterprises with more than 1200 premium studies in a year, M&M is catering to a multitude of clients across 8 different industrial verticals. We specialize in consulting assignments and business research across high growth markets, cutting edge technologies and newer applications. Our 850 fulltime analyst and SMEs at MarketsandMarkets are tracking global high growth markets following the "Growth Engagement Model - GEM". The GEM aims at proactive collaboration with the clients to identify new opportunities, identify most important customers, write "Attack, avoid and defend" strategies, identify sources of incremental revenues for both the company and its competitors.

M&M's flagship competitive intelligence and market research platform, "RT" connects over 200,000 markets and entire value chains for deeper understanding of the unmet insights along with market sizing and forecasts of niche markets. The new included chapters on Methodology and Benchmarking presented with high quality analytical infographics in our reports gives complete visibility of how the numbers have been arrived and defend the accuracy of the numbers.

We at MarketsandMarkets are inspired to help our clients grow by providing apt business insight with our huge market intelligence repository.

Contact: Mr. Rohan MarketsandMarkets 701 Pike Street Suite 2175, Seattle, WA 98101, United States 1-888-600-6441 Email: sales@marketsandmarkets.com

Visit MarketsandMarkets Blog @ http://mnmblog.org/market-research/healthcare/biotechnology

Connect with us on LinkedIn @http://www.linkedin.com/company/marketsandmarkets

SOURCE MarketsandMarkets

View original post here:

Stem Cell Therapy Market Worth 145.8 Million USD by 2021 - PR Newswire (press release)

Lung Institute | Stem Cell Therapy For Lung Disease

* All treatments performed at Lung Institute utilize autologous stem cells, meaning those derived from a patient's own body. No fetal or embryonic stem cells are utilized in Lung Institute's procedures. Lung Institute aims to improve patients' quality of life and help them breathe easier through the use of autologous stem cell therapy. To learn more about how stem cells work for lung disease, click here.

All claims made regarding the efficacy of Lung Institute's treatments as they pertain to pulmonary conditions are based solely on anecdotal support collected by Lung Institute. Individual conditions, treatment and outcomes may vary and are not necessarily indicative of future results. Testimonial participation is voluntary. Lung Institute does not pay for or script patient testimonials.

Under current FDA guidelines and regulations 1271.10 and 1271.15, the Lung Institute complies with all necessary requirements for operation. Any individual who accesses Lung Institute's website for information is encouraged to speak with his or her primary physician for treatment suggestions and conclusive evidence. All information on this site should be used for educational and informational use only.

Excerpt from:

Lung Institute | Stem Cell Therapy For Lung Disease

Stem Cell Therapy for Neck & Back Pain – DC Metro Area

Stem Cell Therapy share

Painful discs in the neck or low back are common causes of severe back pain and disability. Historically, therapies did not exist to regenerate the degenerative process in a vertebral disc, often leaving surgical intervention as the only option if other non-operative treatment options have failed. In selected patients, we now have hopes of better ways to treat spinal disease. Regenerative therapies for the spine are the future for spinal treatments. We are excited to offer innovative techniques as new and improved ways to try to heal spinal problems without having to undergo surgery. Regenerative therapy options hold wonderful healing potential and represent the future of modern medicine.

In the United States alone, more than 400,000 lumbar discectomies and 500,000 spinal fusions are performed each year for symptoms related to lumbar disc degeneration. The ability to get these to heal without surgery has been a long-term goal of many patients and physicians alike.At Virginia Spine Institute, we are working to promote healing without surgery. Virginia Spine Institute continues to be on the forefront of treatment options and is proud to offer stem cell therapy treatments for patients as part of ourcomprehensive non-operative treatment options.

We obtain a patients own stem cells by aspirating tissue from the patient's hip bone or from their fat cells. These cells are centrifuged down to identify and separate specific primitive cells that will help heal tissues. Stem cells are theninjected into the disc, stimulating healing of the disc by using these primitive blood cells to stimulate regeneration of the collagen within the disc. We are excited to report improvements in our patients treated with stem cells.

What are Stem Cells?

Stem cells are undifferentiated cells that have the potential to become specialized types of cells. Stem cells can be categorized as embryonic stem cells or adult stem cells.Embryonic stem cells are derived from a human fetus; there are many ethical concerns with embryonic stem cells, and these are not used in our practice.

Adult stem cells are derived from adults, sometimes obtained from your very own body! Adult stem cells are further divided into different categories. For example, the types of adult stem cells we use to treat musculoskeletal issues are known as mesenchymal stem cells (MSCs). These are multi-potent cells that can differentiate into bone cells, cartilage cells, or fat cells. Its important to note that they cannot differentiate into any other type of cell.

The human body has multiple storage sites for stem cells to repair degenerated and injured structures. We have found that obtaining stem cells from the hip bone (iliac bone) is easily performed within minutes and, in most cases, is a fairly painless procedure for the patient. The stem cells are obtained from your own bone marrow; just minutes later, they are used for treatment.

This procedure is done in our office and starts with the patient lying face down on the examination table. The skin is first numbed with a novocaine solution. After that, the cortex of the hip bone (iliac bone) is numbed. Next, under x-ray (fluoroscopic) guidance, a special needle is advanced through the bone to the cortex of your hip bone into the bone marrow. The liquid marrow - which contains the stem cells - is then withdrawn into a syringe. Finally, the needle is removed, and a small bandage is placed where the needle was inserted.

After the procedure, the syringe of stem cells is taken to the lab and placed in a specialized machine called a centrifuge. The centrifuge spins the bone marrow solution and stem cells are separated from the non-useful cells. The concentrated stem cells are then transferred to a new syringe. Now, the stem cells are ready for the treatment.

Not all patients will be a candidate for these disc regeneration procedures. For those whom are ideal candidates, this provides great hope with reduction in pain and improved quality of life without the need for major surgery. We are excited about these great advances in health care and look forward to helping you live pain free.

Stem cell injections are most commonly used for treatment of the following conditions:

The area of injury is first identified using ultrasound or fluoroscopy. The area is then sterilized, and the skin above the area is numbed with a novocaine-type solution. Using ultrasound or fluoroscopic guidance, the needle is guided to the area of injury, and the stem cell solution is injected. All the regenerative injections performed at our practice are performed under image guidance with ultrasound or fluoroscopy to confirm accurate placement of the stem cells.

The risks depend on the area being treated; however, there is always a potential risk of an injection causing infection, bleeding, or nerve damage. It is important to note that there is no risk of allergic reaction since you are using your own stem cells. At Virginia Spine Institute we always recommended the safest and most efficient procedures for our patients, however, your physician will review any possible risks associated with this treatment prior to administering.

The benefit is usually seen approximately two to three months after the whole treatment protocol has completed; however, you may start to notice the benefit sooner than this.

In most cases, patients respond very well to just one treatment; however, the patient may require two to three injections. We never perform more than three injections within a span of 12 months.

Virginia Spine Institute is part of an ongoing FDA clinical trial study and now also offers stem cell therapy to patients not enrolled in the study. This pioneering cell therapy, currently under investigation by our physicians, shows promise in restoring the structure of degenerating discs and alleviating pain after other non-operative treatments have failed.

The clinical trial uses NuQu (made by ISTO Technologies, Inc) to attempt to restore a damaged disc to save the disc and prevent further degeneration. NuQu is composed of culture-expanded juvenile cartilage cells (stem cells) in a protein-based carrier. These cells have been proven to have far greater regenerative potential than adult cartilage-forming cells based upon preliminary investigations.

After evaluating hundreds of patients for the FDA trial comparing these cartilage forming stem cells to a saline placebo, the spinal experts at Virginia Spine Institute were able to enroll 5 patients in the study. Although early results have been promising, the evaluation will not be complete until a full year passes after the injection.

Although NuQu is an early-stage, cell-based therapy aimed at treating the cause of back pain associated with degenerating discs, we remain optimistic that it has the potential to cure this disease. This pioneering cell therapy, currently under investigation by our physicians, shows promise in restoring the structure of degenerating discs and alleviating pain after other non-operative treatments have failed and before surgery even becomes a consideration.

More here:

Stem Cell Therapy for Neck & Back Pain - DC Metro Area

Stem Cell Transplant | Stem Cell Therapy & Treatment

Current Patients 480.998.7999

New Patients 480.400.8506

Dr. Todd Malan is considered one of the true pioneers of fat derived stem cell therapies in the USA. In October of 2009, Dr. Todd Malan was the first U.S. physician to utilize adipose or fat derived stem cells for soft tissue reconstruction. He has described his techniques and experience as an author in two medical textbooks as well as having presented at dozens of stem cell conferences worldwide.

Mycal's Story: Knee Conditions

Cara's Story: Hereditary Inclusion Body Myopathy

Dale's Story: No more Pain Medications

"I wanted to thank you all so much for making every step of my procedure pleasant and easy. Your dedication to excellence shines through."

- Jen R, Minnesota

"We appreciate your excellence and expertise. You treated us like family and have given us hope. I am walking without limping."

- Doug J, New Mexico

"I just wanted you to know how enormously grateful I am to all of you there. The stem cell treatment had a profound impact on my life! I can't thank you enough."

- Sean H, Arizona

"I can run my finger along the area of the achilles tendon where the damaged fibers were and feel a distinct edge. In terms of function, it is very close to full function. My never ending thanks for what you have done for me!"

- Kathy D, California

" I just got back from visiting Dr. Karen Herbst and she was amazed at my improvement. I have lost 15 more pounds and lost lots of the fibrous tissue in the tumors. She was amazed. I have tons more energy that I feel I have a life now that I did not have. Brain fog is much better now. As I say, I have a life now, a life that is so much better than it was 6 months ago. Again, thank you and God bless."

- Linda K, Kansas (Dercums disease patient)

Nykol is a beautiful, bright 22 year old student who underwent an Adult Stem Cell Therapy utilizing Stem Cells from her own fat. Hear her story and share her inspiring message of HOPE!

- Nykol

Eyrk Anders, Professional MMA fighter and rising star talks about his experience with Dr. Todd Malan's Stem Cell Therapy and his road to recovery from multiple sports related Injuries without the need for invasive surgery.

- Eyrk

Meet Jim, He is living with Periodic Paralysis, a rare inherited disorder that causes episodes of weakness and muscle paralysis. Often patients have limited treatment options and can have a severely impaired quality of life. Listen to Jim's story of hope and how Adult Stem Cell Therapy improved his quality of life. Stem Cell Therapy is considered experimental and individual results may vary. Contact us at mystemcelltherapy.com to learn more and see if Adult Stem Cell Therapy may be for you.

- Jim

Those who access this web site should consult their Physician before following any of the suggestions or making any conclusions from the website.

The website contains the opinions of multiple authors intended for educational purposes with the understanding that the publications or editorials are not providing any professional services. CRCM and its associates disclaim any liability, loss, or risk, directly or indirectly of the application of any of the contents of the website.

View original post here:

Stem Cell Transplant | Stem Cell Therapy & Treatment

Exclusive: CBMG CEO Talks Stem-Cell Therapies, Cancer Treatments, Financials & The Chinese Market – Benzinga

Cellular Biomedicine Group Inc (NASDAQ: CBMG) is a micro-cap biomedicine company focused on the development of treatments for cancerous and degenerative diseases through cell-based technologies.

Last week, Benzinga attended SCN Corporate Connects Family Office & Life Science Symposium at the NASDAQ and had the chance to talk with CBMG CEO Tony Liu who walked us through some of the companys products, management team, market potential, how they use stem cells and more.

CBMG has two leading technology platforms at the time, Liu began. One is an immune cell therapy aimed at the treatment of a broad range of cancers using Cancer Vaccines, Chimeric Antigen Receptor T cell (CAR-T) and anti-PD-1 Technologies. The other one uses stem cells for regenerative purposes; the key indication for this therapy is knee osteoarthritis.

Our focus is on these technologies and our market is China, because that is the largest -by far- in population for the indication, he pointed out.

Benzinga: How does the company use stem cells.

Liu: In simple terms, a stem cell is basically regenerative. So a stem cell has the enormous power of expanding, continue from the embryonic stem cell to the baby stem cell and ultimately to the adult stem cell, so it has a great ability to continue to expand and grow.

From the medical perspective, an adult stem cell can regenerate, it can repair [tissue]. So, in our lead product, we use fat tissue from the stomach and we all have a few ounces of extra fat. We take the stem cell out from the fat tissue culture, expand it, and then we inject back in the kneecap for patients with a knee osteoarthritis problem.

Benzinga: Are there any other indications you will be targeting in the near-future?

Liu: Were targeting lymphoma, leukemia, solid tumors and many other areas.

Benzinga moved on to ask about the size of the market.

Liu: Every year we look at 4.5 million to 5 million new cancer patients. That is, every minute we are talking about eight or nine new cancer patients. That is why it is a huge social issue. That is one of the reasons why I choose to stay in the business after I spent 19 years with Microsoft Corporation (NASDAQ: MSFT) and four years with Alibaba Group Holding Ltd (NYSE: BABA). I think this area socially, you want to make impactful, and economically I think there is a huge business from that side.

Because our focus is on the Chinese market there are many investors in the U.S. who do not know us well. However, I believe investors should look at the company: we have a huge market, great scientists, manufacturing space

Then, for our stem cell therapies in China, 57 million people have a knee issue; in the U.S., 27 million [people] have a knee issue. Stem cells can help knees regenerate by doing two things. First, by helping with the pain, providing symptom relief and functional improvements. Secondly, they regenerate the cartilage, which originally caused the knee problem. Nowadays, patients can only opt between pain pills or a knee replacement.

Today, if you do a knee replacement, you are looking at tens of thousands [of dollars]. So, any way you look at it, [its a] multi-billion [market] for knee treatments.

Benzinga: When you say stem cells, people imagine It is a slightly controversial subject; it has some political implications. So, what is the Chinese governments stance regarding stem cells? Are there any risks? Is it accepted? What is the view of stem cells in China?

Liu: Chinas government has been extremely supportive of using stem cells. I think the controversy comes in where people use embryonic stem cells, when you create a new life, that is where the controversy is. But, we use what we call adult stem cells to improve peoples lives, improve their life experiences

On adult stem cells, there is little controversy. The policy of Chinas government is very clear. In fact, in the U.S. it is very clear as well. CBMG has been graced to work with the California Stem Cell Institute. Potentially, we are going to ask the U.S. for large-scale clinical trials.

Our management team was educated in the U.S., and has experience managing large businesses, Liu commented. Our Chief Scientific Officer is a former MedImmune/AstraZeneca plc (ADR) (NYSE: AZN) director. Some of our oncology scientists are from there as well. We also have scientists from the National Cancer Institute. We also have a person who is leading our manufacturing capabilities who worked for Harvard for 30 years and a top German company, leading research for seven years total.

So, we have this kind of people with skills come to China. Our company has 130 people with PhDs, and more than 30 with post-doctorate studies, so there is a lot of brain power, I believe, and we have a common vision that is to create the best, first in class, biotech business in China.

Benzinga: Whats one objective you have as a CEO for 2017?

Liu: In 2017 is about clinical, clinical, clinical. We now have moved our first two indications into the clinical trial stage. We have a lot of patients lined up for clinical trials.

So, as CEO Ill make sure we mobilize all the resources around the clinical trials and make sure we have the lead PI, lead hospitals, and we have resources waiting in the company to make sure we have successful clinical trials. Those are key elements, and we are confident that we should be able to move forward, given the number of patients we have, move schedule, look at the indications

Benzinga: Are you comfortable with your cash and debt position? Do you have any plans to raise capital this year or any time soon?

Liu: One of the benefits we have, CBMG has been regarded as the leader in Chinas cell therapy space, so we have investors who have given us money for the last three years, always at a premium to the market. They know who we are; they know the space we are in. I feel as we move forward, we will be getting more investment needs from trials, and I feel confident investors will look at CBMG as a way for them to both put money into the research, but also, as an investment that could reap great returns.

Benzinga: Your stock had been performing pretty well, but experienced a tumble between mid-November and late-February. What happened there?

Liu: CBMGs stock is really thinly traded. Much of the stock is owned by those who have been with the company for a long time; so, they dont sell. Having said this, there are many reasons that drive stocks: the U.S. election, the pricing discussion Many investors dont discriminate, and just punish biotech as a whole. However, CBMG is not really subject to most of these pricing pressures. In fact, because we have a different cost structure, I expect CBMG to do extremely well.

Image Credit: By Ryddragyn at English Wikipedia - Transferred fromen.wikipediato Commons., Public Domain, via Wikimedia Commons

Posted-In: Biotech News Emerging Markets Health Care Events Exclusives Markets Tech Best of Benzinga

2017 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

Read more here:

Exclusive: CBMG CEO Talks Stem-Cell Therapies, Cancer Treatments, Financials & The Chinese Market - Benzinga

D-backs’ De La Rosa counting on stem-cell therapy to avoid second Tommy John – Arizona Sports (registration) (blog)

Rubby De La Rosa had already undergone Tommy John surgery. So when his right elbow became an issue again, he had a tough decision to make.

He could have the surgery again and risk that it might not be as effective the second time around. Or he could venture down another avenue.

Either way, his career was at stake.

De La Rosa was in his second season as a Diamondback when it was interrupted in September by a familiar pain in his elbow.

His rookie season with the Dodgers in 2011 was cut short for the same reason. He ended up having his first Tommy John procedure.

So when the issue arose again last season, he and Dr. James Andrews who performed De La Rosas first Tommy John surgery discussed the options. They decided stem-cell therapy would be more effective than a second surgery. De La Rosa then received one stem cell injection in late September and another in December.

He has been playing catch and said he feels 100-percent healthy, but he will not begin throwing off the mound until mid-March.

What I see from it right now, its working, said De La Rosa, who will be 28 years old March 4. No more pain, no more soreness. Just waiting for my time.

Dr. Keith Jarbo is an orthopedic surgeon with OrthoArizona who specializes in elbow surgery. Jarbo, who has performed many Tommy John surgeries to repair the ulnar collateral ligament, said the procedure is less effective the second time around.

Stem-cell therapy has become more popular in orthopedics over the past five to 10 years, Jarbo said. Some doctors even use it in addition to Tommy John surgery to accelerate the healing process. He said stem cells are used because they are pluripotent, meaning they can develop into every type of cell that makes up the body.

They have a lot of the growth factors that are necessary for healing, Jarbo said. We think they can be important adjuncts for healing.

However, there is a risk. Jarbo said there is no research that compares the efficacy of stem-cell therapy to that of Tommy John surgery. With the lack of research, Jarbo said one doctor may be using different types of stem cells than another.

He said he doesnt use stem cells and wont until there is more research that shows it is effective. Until then, he cant assure his patients that stem-cell therapy will produce a ligament that has similar characteristics to what it did before the injury.

Its high-risk in the sense that we dont know exactly what its going to do, Jarbo said. We think that it promotes healing, but we dont know exactly what growth factors are within or whats going to happen.

I dont think youre necessarily getting a new, better tissue as if youre developing a robot. Youre really just trying to get good healing and strong appropriate tissue, whether thats with surgery or not.

Jarbo estimated Andrews conducts over 100 Tommy John surgeries per year. He said doctors like Andrews may be helpful in researching stem-cell therapys effectiveness if they can use stem cells on half of their patients and compare the results with the half that received Tommy John surgery.

De La Rosa is part of a group of trendsetters. Last season, Los Angeles Angels of Anaheim pitchers Garrett Richards and Andrew Heaney both received stem cell injections to stave off Tommy John surgery. Heaney ended up needing the surgery anyway.

D-backs manager Torey Lovullo said De La Rosa seems encouraged by his health.

We just know that Rubby is in a really good place, hes been throwing the ball really well hes smiling, and hes back to himself, which is always a good sign for him, he said.

Diamondbacks pitching coach Mike Butcher said stem-cell therapy is unpredictable, but seems to helping De La Rosa.

Its obviously helped out Rubby, Butcher said. The results have been good so far; he feels great. Now its just a matter of working toward the progression of where we can get him off the mound.

Jarbo said the largest risk with using stem-cell therapy may be that players are rushed back to action through an accelerated rehab program.

However, De La Rosa has been patient throughout his now five-month recovery.

He hopes it means the end of his elbow pain.

Its frustrating because sometimes you want to pitch but you cannot pitch because theres a lot of soreness, he said. When you do it right and you get hurt and everything switches, now you cant pitch with your whole motion and you have to limit a lot of things.

You get bad pitching.

Follow this link:

D-backs' De La Rosa counting on stem-cell therapy to avoid second Tommy John - Arizona Sports (registration) (blog)