Husband testifies wife ‘was looking for a cure’ and found Bonita stem-cell doctor

The Grekos hearing is scheduled to resume today. The location is the Collier County Courthouse in room 4-D, according to a case filing Monday.

The hearing before J. Lawrence Johnson, an administrative law judge from Tallahassee, is scheduled to last four days. The Collier County Courthouse is located at 3315 U.S. 41 E.

Photo by Allie Garza

Zannos Grekos

EAST NAPLES The patient was friends with the mother of Dr. Zannos Grekos, a Bonita Springs cardiologist who performed stem cell therapy on people with debilitating illnesses.

Chemotherapy for breast cancer several years earlier had left the 69-year-old patient, Domenica Fitzgerald, with numbness in her legs. She was unable to walk for more than 10 minutes. She hoped Grekos and his stem cell treatment could help.

"She was looking for a cure. She wanted to get well," her husband, John "Jack" Fitzgerald, testified Tuesday.

A four-day administrative hearing started Tuesday in a Collier County courtroom for a state Department of Health complaint against Grekos. The state says he committed medical malpractice and violated other standards of care when he performed a stem cell treatment on the patient on March 24, 2010. The patient suffered brain damage.

The state is only identifying the patient in its complaint by her initials, D.F. The Daily News learned of her identity by a public records request to the Collier County Medical Examiner's Office of all people who died on April 4, 2010, in the county. That was the day that Fitzgerald died after being taken off life support.

The state last year restricted Grekos' license after her death and ordered him not to do anything with stem cells with other patients. His license was fully suspended earlier this year when the state said he violated the order by treating another patient who also died.

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Husband testifies wife 'was looking for a cure' and found Bonita stem-cell doctor

Realizing the potential of stem cell therapy: Studies report progress in developing treatments for diseases and injuries

ScienceDaily (Oct. 15, 2012) New animal studies provide additional support for investigating stem cell treatments for Parkinson's disease, head trauma, and dangerous heart problems that accompany spinal cord injury, according to research findings released today.

The work, presented at Neuroscience 2012, the annual meeting of the Society for Neuroscience and the world's largest source of emerging news about brain science and health, shows scientists making progress toward using stem cell therapies to repair neurological damage.

The studies focused on using stem cells to produce neurons -- essential, message-carrying cells in the brain and spinal cord. The loss of neurons and the connections they make for controlling critical bodily functions are the chief hallmarks of brain and spinal cord injuries and of neurodegenerative afflictions such as Parkinson's disease and ALS (amyotrophic lateral sclerosis), also known as Lou Gehrig's disease.

Today's new findings show that:

Other recent findings discussed show that:

"As the fields of developmental and regenerative neuroscience mature, important progress is being made to begin to translate the promise of stem cell therapy into meaningful treatments for a range of well-defined neurological problems," said press conference moderator Jeffrey Macklis, MD, of Harvard University and the Harvard Stem Cell Institute, an expert on development and regeneration of the mammalian central nervous system. "Solid, rigorous, and well-defined pre-clinical work in animals can set the stage toward human clinical trials and effective future therapies."

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The above story is reprinted from materials provided by Society for Neuroscience (SfN), via AlphaGalileo.

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Realizing the potential of stem cell therapy: Studies report progress in developing treatments for diseases and injuries

Beauty salon ‘offers’ stem cell therapy

With all the publicity about the miraculous effects of stem cell therapy, the Department of Health (DOH) should prepare itself for the possibility that the new procedure would be performed by unqualified, and completely clueless, people.

I passed a beauty parlor recently and saw a huge poster on its door announcing the arrival of stem cell therapy. I was instantly reminded of botched breast enhancement and nose jobs performed by salon personnel who seemed to think it was as easy to learn complicated surgical procedures as it was to train to cut hair or do manicures and pedicures.

The DOH should start warning the public not to fall for these special offers just because they are available at giveaway rates.

Modern lifestyle problem

Experts have repeatedly talked about problems brought about by modern lifestyles. Changing diets and stress are two of the best known. Dr. Jaime G. Ignacio, section chief of gastroenterology at Veterans Hospital and head of the Digestive Malignancy Council of the Philippine Society of Gastroenterology, said constipation could be one of the consequences of the combination of these two factors.

Speaking at an event hosted by Boehringer Ingelheim, maker of Dulcolax (generic name Bisacodyl), a formulation for constipation relief, Ignacio, who, as a gastroenterologist is a specialist in digestive system disorders, defined the problem as having fewer than three bowel movements in a week (normal ranges from three times a week to three times a day).

He said constipation itself was not a disease but it could sometimes be a symptom of something serious, like colorectal cancer. But he said about 95 percent of cases were acuteoccurring suddenly and lasting for only a short periodresulting from some sudden lifestyle or hormonal changes, the taking of medication, lack of exercise, etc.

Ignacio said acute was easy to treat, with products like Dulcolax to solve the problem. But, if left unattended, acute constipation could lead to a chronic or long-term condition, which was the more worrisome, and would need medical attention.

He said constipation should be treated as soon as the problem had lasted for four or more days.

Constipation is part of modern living. [Like other diseases] prevention is the key. Safe and effective treatment is available [if needed], Ignacio stressed.

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Beauty salon ‘offers’ stem cell therapy

State licensing hearing for Bonita Springs stem cell doctor to begin Tuesday

The Grekos hearing is scheduled to begin at 9 a.m. Tuesday. The location has changed to the Collier County Courthouse in room 4-D, according to a case filing Monday.

The hearing before J. Lawrence Johnson, an administrative law judge from Tallahassee, will begin at 9 a.m. The hearing is scheduled to last four days. The Collier County Courthouse is located at 3315 U.S. 41 E.

Photo by Allie Garza

Zannos Grekos

BONITA SPRINGS Bonita Springs physician Zannos Grekos, whose license is in jeopardy for controversial stem cell therapy, is getting his day before a judge.

Barring a last-minute delay or settlement, an administrative hearing is scheduled to begin Tuesday in Naples for the 47-year-old. He is fighting to get his license back in good standing from a suspension order, while the state Department of Health is pursuing more discipline and potentially revocation of his license.

Trained as a cardiologist, he's been licensed in Florida since 1996.

The trial-like proceeding, without a jury, is scheduled for four days before an administrative law judge. The proceeding is open to the public. The case against Grekos has garnered considerable media attention, including CNN and inquiries from European media.

A Texas father, Jimmy Bell, will be tracking what happens. Last year, he paid $57,000 upfront for his 5-year-old son, Jason, to undergo stem cell therapy to fight pulmonary hypertension. Despite pleas that his boy was weakening by the day, the treatment was never scheduled and Jason died. Bell received a $10,000 refund.

"He's taking advantage of people and it's more for personal gain," Bell said. "I'd like to see that stopped."

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State licensing hearing for Bonita Springs stem cell doctor to begin Tuesday

RBCC: Could Stem Cells Be Key to Promising Autism Therapy?

NOKOMIS, Fla.--(BUSINESS WIRE)--

Rainbow Coral Corp. (RBCC) subsidiary Rainbow BioSciences will keep a close eye on a new study that could potentially lead to stem cell therapies for children with autism.

Researchers have been given the go-ahead by the FDA to launch a small study evaluating the effectiveness of autism treatments using patients own umbilical cord blood. Thirty children, aged two to seven, will receive injections of their own stem cells from the cord blood banked by their parents at birth.

Scientists will evaluate whether the stem cell therapy helps improve language and behavior in the children. Although the cause of autism is unknown and there is no cure for the disorder, one theory suggests that autism occurs because cell in the brain, known as neurons, are not connecting normally. Its possible that stem cells may address this problem.

RBCC is working to capitalize on the rising demand for effective new stem cell treatments by bringing a potentially game-changing stem cell technology to market. The company is close to a deal with Regenetech to acquire a license to perform cell expansion using that companys Rotary Cell Culture SystemTM, a rotating-wall bioreactor originally developed by NASA.

The rotating-wall bioreactor is capable of multiplying functional, 3-D stem cells for use in a variety of research projects, said RBCC CEO Patrick Brown. Stem cells carry tremendous potential to help researchers develop new treatments and cures for devastating diseases from Parkinsons to Alzheimers and even autism, but much research must be done first. Consequently, were very optimistic about the market potential for this revolutionary bioreactor technology.

RBCC plans to offer the new technology to help kickstart billions of dollars worth of research in an industry currently dominated by Amgen, Inc. (AMGN), Celgene Corporation (CELG), Genzyme Corp. (NASDAQ:GENZ) and Gilead Sciences Inc. (GILD).

For more information on Rainbow BioSciences, please visit http://www.rainbowbiosciences.com/investors.html.

About Rainbow BioSciences

Rainbow BioSciences, LLC, is a wholly owned subsidiary of Rainbow Coral Corp. (OTCBB:RBCC). The company continually seeks out new partnerships with biotechnology developers to deliver profitable new medical technologies and innovations. For more information on our growth-oriented business initiatives, please visit our website at [http://www.RainbowBioSciences.com]. For investment information and performance data on the company, please visit http://www.RainbowBioSciences.com/investors.html.

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RBCC: Could Stem Cells Be Key to Promising Autism Therapy?

Realizing the potential of stem cell therapy

Public release date: 15-Oct-2012 [ | E-mail | Share ]

Contact: Kat Snodgrass 202-962-4090 Society for Neuroscience

NEW ORLEANS New animal studies provide additional support for investigating stem cell treatments for Parkinson's disease, head trauma, and dangerous heart problems that accompany spinal cord injury, according to research findings released today. The work, presented at Neuroscience 2012, the annual meeting of the Society for Neuroscience and the world's largest source of emerging news about brain science and health, shows scientists making progress toward using stem cell therapies to repair neurological damage.

The studies focused on using stem cells to produce neurons essential, message-carrying cells in the brain and spinal cord. The loss of neurons and the connections they make for controlling critical bodily functions are the chief hallmarks of brain and spinal cord injuries and of neurodegenerative afflictions such as Parkinson's disease and ALS (amyotrophic lateral sclerosis), also known as Lou Gehrig's disease.

Today's new findings show that:

Other recent findings discussed show that:

"As the fields of developmental and regenerative neuroscience mature, important progress is being made to begin to translate the promise of stem cell therapy into meaningful treatments for a range of well-defined neurological problems," said press conference moderator Jeffrey Macklis, MD, of Harvard University and the Harvard Stem Cell Institute, an expert on development and regeneration of the mammalian central nervous system. "Solid, rigorous, and well-defined pre-clinical work in animals can set the stage toward human clinical trials and effective future therapies."

###

This research was supported by national funding agencies such as the National Institutes of Health, as well as private and philanthropic organizations.

Todd Bentsen, (202) 962-4086

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Realizing the potential of stem cell therapy

Stem-cell transplant claims debunked

Hisashi Moriguchi presented his work at the New York Stem Cell Foundation meeting this week.

AP/Press Association

From the beginning, it seemed too good to be true. Days after Kyoto University biologist Shinya Yamanaka won a Nobel prize for his 2006 discovery of induced pluripotent stem (iPS) cells (see 'Cell rewind wins medicine Nobel'), Hisashi Moriguchi a visiting researcher at the University of Tokyo claimed to have modified that technology to treat a person with terminal heart failure. Eight months after surgical treatment in February, said a front-page splash in the Japanese newspaper Yomiuri Shimbun yesterday, the patient was healthy.

But after being alerted to the story by Nature, Harvard Medical School and Massachusetts General Hospital (MGH), where Moriguchi claimed to have done the work, denied that the procedure had taken place. No clinical trials related to Dr Moriguchi's work have been approved by institutional review boards at either Harvard University or MGH, wrote David Cameron, a spokesman for Harvard Medical School in Boston, Massachusetts. The work he is reporting was not done at MGH, says Ryan Donovan, a public-affairs official at MGH, also in Boston.

A video clip posted online by the Nippon News Network and subsequently removed showed Moriguchi presenting his research at the New York Stem Cell Foundation meeting this week.

If true, Moriguchis feat would have catapulted iPS cells into use in a wide range of clinical situations, years ahead of most specialists' predictions. I hope this therapy is realized in Japan as soon as possible, the head of a Tokyo-based organization devoted to helping children with heart problems told Yomiuri Shimbun.

But there were reasons to be suspicious. Moriguchi said he had invented a method to reprogram cells using just two chemicals: microRNA-145 inhibitor and TGF- ligand1. But Hiromitsu Nakauchi, a stem-cell researcher at the University of Tokyo, says that he has never heard of success with that method. He adds that he had also never heard of Moriguchi before this week.

Moriguchi also said that the cells could be differentiated into cardiac cells using a 'supercooling' method that he had invented. Thats another weird thing, says Nakauchi.

The article in which Moriguchi presented his two-chemical method, published in a book1 describing advances in stem-cell research, includes paragraphs copied almost verbatim from other papers. The section headed 2.3 Western blotting, for example, is identical to a passage from a 2007 paper by Yamanaka2. Section 2.1.1, in which Moriguchi describes human liver biopsies, matches the number of patients and timing of specimen extractions described in an earlier article3, although the name of the institution has been changed.

When contacted by Nature, Moriguchi stood by his publication. We are all doing similar things so it makes sense that wed use similar words, he says. He did admit to using other papers as reference.

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Stem-cell transplant claims debunked

Bay Area stem cell researchers see encouraging results

SAN FRANCISCO (KGO) -- Bay Area stem cell researchers are reporting early, encouraging results from two clinical trials. The first, involves patients, paralyzed with spinal cord injuries and a treatment that could offer new hope for their future.

Nearly 20 years after the football injury that left him paralyzed, Roman Reed still holds onto the hope that he will someday walk again.

"One hundred percent, without a doubt. I've been wrong about the date, but not the fact I will walk again," said Reed.

Reed now runs a foundation to promote stem cell research and has been closely watching a clinical trial being conducted by Bay Area based Stem Cells Inc. Its goal is to use stem cell therapy to restore motor function in patients with spinal cord injuries.

"We're on the road on to being able to cure paralysis, it's so important, and stem cells are the way to do it," said Reed.

Stephen Huhn, M.D., Ph.D., from Stem Cells Inc., says the test procedure began a two hour surgery to clear a path to the spinal cord. Researchers then injected the cells directly into the damaged area.

"So the first three patients in the trial were designed to enroll patients who had the worst of the worst injuries. In other words, complete loss of sensory function and complete loss of motor function below the level of injury," said Huhn.

The phase one trials are all about establishing safety, but six months out, the researchers began measuring some intriguing improvements in two of those three patients. Both reported feeling in areas below the areas of their injuries.

The company cautions that the data is very preliminary, but they say researchers were able to measure the improved sensory response using several testing methods, including electrical stimulation, and response to heat -- which are considered more accurate than the patient's own self-reporting.

"You can't fake that. When we saw that data, that's when we became very excited," said Martin McGlynn, the CEO of Stems Cells Inc.

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Bay Area stem cell researchers see encouraging results

Stem cells from muscle tissue may hold key to cell therapies for neurodegenerative diseases

Public release date: 12-Oct-2012 [ | E-mail | Share ]

Contact: Marguerite Beck marbeck@wakehealth.edu 336-716-2415 Wake Forest Baptist Medical Center

WINSTON-SALEM, N.C. Oct. 12, 2012 Scientists at Wake Forest Baptist Medical Center have taken the first steps to create neural-like stem cells from muscle tissue in animals. Details of the work are published in two complementary studies published in the September online issues of the journals Experimental Cell Research and Stem Cell Research.

"Reversing brain degeneration and trauma lesions will depend on cell therapy, but we can't harvest neural stem cells from the brain or spinal cord without harming the donor," said Osvaldo Delbono, M.D., Ph.D., professor of internal medicine at Wake Forest Baptist and lead author of the studies.

"Skeletal muscle tissue, which makes up 50 percent of the body, is easily accessible and biopsies of muscle are relatively harmless to the donor, so we think it may be an alternative source of neural-like cells that potentially could be used to treat brain or spinal cord injury, neurodegenerative disorders, brain tumors and other diseases, although more studies are needed."

In an earlier study, the Wake Forest Baptist team isolated neural precursor cells derived from skeletal muscle of adult transgenic mice (PLOS One, Feb.3, 2011).

In the current research, the team isolated neural precursor cells from in vitro adult skeletal muscle of various species including non-human primates and aging mice, and showed that these cells not only survived in the brain, but also migrated to the area of the brain where neural stem cells originate.

Another issue the researchers investigated was whether these neural-like cells would form tumors, a characteristic of many types of stem cells. To test this, the team injected the cells below the skin and in the brains of mice, and after one month, no tumors were found.

"Right now, patients with glioblastomas or other brain tumors have very poor outcomes and relatively few treatment options," said Alexander Birbrair, a doctoral student in Delbono's lab and first author of these studies. "Because our cells survived and migrated in the brain, we may be able to use them as drug-delivery vehicles in the future, not only for brain tumors but also for other central nervous system diseases."

In addition, the Wake Forest Baptist team is now conducting research to determine if these neural-like cells also have the capability to become functioning neurons in the central nervous system.

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Stem cells from muscle tissue may hold key to cell therapies for neurodegenerative diseases

Regenevéda Opens Flagship Stem Cell Therapy Clinic in Beverly Hills

Beverly Hills, CA (PRWEB) October 12, 2012

Regenevda (http://www.regeneveda.com) recently opened its brand new flagship facility in Beverly Hills. Founded by world renowned surgeon Dr. Thom Lobe, Regenevda specializes in cutting edge anti-aging treatments such as Stem Cell Therapy, IV Vitamin Therapy, and HGH Therapy.

Dr. Thom Lobe is an internationally respected surgeon and has been in practice for over 30 years. Consistently pioneering advances in medicine, Dr. Lobe was one of the first doctors to ever separate conjoined twins. Consistently working to help make advances in medicine, Dr. Lobe also has over 200 publications to his credit.

Overseeing the business aspect of Regenevda is Lindsey Combs. She is responsible for sales, staff, accounting, facility management, and business development. A graduate of the University of California, Los Angeles, Ms. Combs has been working in the anti-aging field for over 10 years and has been a California Licensed Esthetician since 2003.

Being one of the very few physicians in the country to hold the most advanced board certification (FAARM), Dr. Lobe is able to offer Stem Cell Therapy at the Regenevda clinic. Inside each persons own body, there are special cells in nearly every organ and tissue that have the ability to help heal damage. These special cells are called Stem Cells and this therapy works by harvesting these cells from a persons own blood, bone marrow, or fat and can help with different conditions. Some examples of procedures that use Stem Cell Therapy are: Stem Cell Facelifts, Stem Cell Breast Augmentation, and Stem Cell Joint Therapy. Stem Cell treatments are safe, non-invasive, and are done under local anesthesia.

Intravenous Nutrition Therapy (or IV Vitamin Therapy) is another anti-aging and rejuvenation treatment that can also help patients prevent migraines, lose weight, fight chronic infections like hepatitis, candida, lyme disease, as well as fight acute infections like the flu and mono. IV Therapy works by using intravenous solutions to deliver vitamins and minerals directly to the body cells. This bypasses the digestive system and provides a more direct method of delivery, which ensures that all of the nutrients required are delivered, allowing the patient to feel an improvement in condition almost immediately.

Human Growth Hormone (HGH) Therapy is another advanced treatment offered at Regenevda. HGH is secreted by the Pituitary gland and fuels cell growth and reproduction. This production peaks at adolescence. Over time, due to the effect of aging, the production of HGH slows down dramatically. As production declines, it makes it more difficult for the body to recover from physical and mental exertion. HGH Therapy acts as a supplement for HGH deficient adults to lessen body fat, boost lipid lineament, improve memory, promote bone density, as well as decrease risk factors that involve cardio-vascular conditions. If used at the onset of the decrease in HGH production, HGH Therapy can help curtail early aging and even be used as preventive measure against osteoporosis. A complete analysis of the patients sex hormones, evaluation of glucose regulation and functions of the adrenal gland, thyroid gland, and pancreas are performed before the treatment is administered for optimal results.

Combining decades of medical experience with the most cutting edge advances in medical technology, the Regenevda clinic looks to pave the way for the future of anti-aging treatments. The Regenevda Beverly Hills Institute of Cellular Therapy is located at 50 North La Cienega Boulevard. For any inquiries, they can be reached at 855-734-3638, or visit http://www.regeneveda.com.

About Regenevda :

Regeneveda, home of The Beverly Hills Institute of Cellular Therapy, provides state-of-the-art Stem Cell Therapy. Stem Cell Therapy is an effective treatment for chronic conditions such as Arthritis, Diabetes, Chronic Sports Injuries, and Chronic Pain, but is also revolutionizing anti-aging treatments such as Breast Enhancement, Erectile Dysfunction, and Facial Aging.

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Regenevéda Opens Flagship Stem Cell Therapy Clinic in Beverly Hills

Safety results of intra-arterial stem cell clinical trial for stroke presented

Public release date: 11-Oct-2012 [ | E-mail | Share ]

Contact: Deborah Mann Lake deborah.m.lake@uth.tmc.edu University of Texas Health Science Center at Houston

HOUSTON (Oct. 11, 2012) Early results of a Phase II intra-arterial stem cell trial for ischemic stroke showed no adverse events associated with the first 10 patients, allowing investigators to expand the study to a targeted total of 100 patients.

The results were presented today by Sean Savitz, M.D., professor of neurology and director of the Stroke Program at The University of Texas Health Science Center at Houston (UTHealth), at the 8th World Stroke Congress in Brasilia, Brazil.

The trial is the only randomized, double-blind, placebo-controlled intra-arterial clinical trial in the world for ischemic stroke. It is studying the safety and efficacy of a regenerative therapy developed by Aldagen Inc., a wholly-owned subsidiary of Cytomedix, Inc., that uses a patient's own bone marrow stem cells, which can be administered between 13 and 19 days post-stroke.

The therapy, called ALD-401, consists of stem cells that are identified using Aldagen's proprietary technology to isolate cells that express high levels of an enzyme that serves as a marker of stem cells. Pre-clinical studies found that these cells enhance recovery after stroke in mice. The cells are administered into the carotid artery. Patients are followed for 12 months to monitor safety and to assess mental and physical function.

"We have been approved by the Data Safety Monitoring Board (DSMB) to move the study into the next phase, which will allow us to expand the number of sites in order to complete enrollment," said Savitz, senior investigator for the multi-center study. As per the protocol for the trial, the Food and Drug Administration required a review by the DSMB prior to advancing to the next phase.

Preclinical research, including research at the UTHealth Medical School, has suggested that stem cells can promote the repair of the brain after an ischemic stroke, which is caused by a blood clot in the brain. Stroke is a leading cause of disability and the fourth-leading cause of death in the United States, according to 2008 statistics reported by the Centers for Disease Control and Prevention.

###

For patient information about the intra-arterial stem cell clinical trial for stroke, call 713-500-7183 or email jennifer.m.garrett@uth.tmc.edu.

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Safety results of intra-arterial stem cell clinical trial for stroke presented

FRC Supports Alliance Defending Freedom, Jubilee Campaign Cert Petition to Supreme Court on Stem Cell Funding

WASHINGTON, Oct. 10, 2012 /PRNewswire-USNewswire/ --Alliance Defending Freedom and the Jubilee Campaign together with Tom Hungar of Gibson, Dunn & Crutcher today filed a petition for certiorari with the U.S. Supreme Court in the case Sherley v. Sebelius, which seeks to end federal funding of human embryonic stem cell research.

Of the petition David Prentice, Ph.D., senior fellow for life sciences at the Family Research Council's Center for Human Life and Bioethics, made the following comments:

"Even as the Nobel Prize committee honors Japanese scientist Shinya Yamanaka for introducing ethical induced pluripotent stem (iPS) cells to the field of medicine, the Obama administration is fighting to continue wasting taxpayer money on unethical embryonic stem cell research, which relies on the destruction of young human life. A plain reading of federal law would specifically prohibit funding of embryonic stem cell research. After years of wasting taxpayer dollars as well as lives on ethically-tainted experiments, it's time for the federal government to start putting that money into lifesaving and ethical adult stem cell research, the gold standard for patient treatments. Such research is saving thousands of lives now lives like that of Chloe Levine who beat cerebral palsy with the help of adult stem cells. Each precious life at every stage and every age deserves our respect, and we should devote our resources and time to the ethical stem cell research that has the best chance of preserving life adult stem cells.

"We are pleased to see this suit move forward, and hope that the Supreme Court will agree to its review and uphold the clear intent of federal law to protect human life from experimentation."

To watch a video about Chloe Levine and adult stem cell therapy, click here : http://www.youtube.com/watch?feature=player_embedded&v=ojjT4yRd5Es

To learn more about adult stem cells, click here : http://www.stemcellresearchfacts.org/

SOURCE Family Research Council

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FRC Supports Alliance Defending Freedom, Jubilee Campaign Cert Petition to Supreme Court on Stem Cell Funding

Scientists discuss stem cell discoveries at New York Stem Cell Foundation Conference

Public release date: 11-Oct-2012 [ | E-mail | Share ]

Contact: David McKeon dmckeon@nyscf.org 212-365-7440 New York Stem Cell Foundation

NEW YORK, NY (October 11, 2012) For the second day, The New York Stem Cell Foundation (NYSCF) Seventh Annual Translational Stem Cell Research Conference hosts the world's most preeminent stem cell scientists to present their findings on how advances in stem cell science lead to better treatments and cures for disease and injury. The conference is held at The Rockefeller University in Manhattan on October 10-11.

Today, in disease-specific sessions, scientists will share their latest finds in moving stem cell research to treatments in the following areas: cancer and blood disease; diabetes and autoimmunity; heart and muscles; neurodegeneration and spinal cord injury.

In Cancer and Blood Disease, Elaine Fuchs, PhD, The Rockefeller University, will share findings on identification of skin cancer stem cells, which have implications in understanding other cancers as well as stem cells. Joanne Kurtzberg, MD, Duke University, will discuss her work developing therapies for disease with autologous cord blood transplants. Ravi Majeti, PhD, Stanford University, will describe his recent insights into acute myeloid leukemia and how stem cell technologies can lead to new cancer treatments.

Dieter Egli, PhD, The New York Stem Cell Foundation (NYSCF), will open the session on Diabetes and Autoimmunity by detailing his group's development of stem cell-derived models of pancreatic beta cells for the study of diabetes. Yuval Dor, PhD, Hebrew University, Israel, will discuss experiments with pancreatic beta cells with the goal to understand the regenerative potential of these cells. Matthias von Herrath, MD, Novo Nordisk, will delve into another aspect of Type 1 diabetes, the problem of autoimmunity. He will close the session by sharing insights into the need for an immune modulated therapy to diabetes.

Before the afternoon sessions, Shahin Rafii, MD, Weill Medical College of Cornell University will deliver the first of two keynote addresses of the conference. He will describe his recent successes in deriving vascular cells from amniotic cells.

In the afternoon session on Heart and Muscle Diseases, Amy Wagers, PhD, Harvard University, will focus on advances in treatments and explain how studies into the mechanisms of tissue stem cell renewal may have relevant therapeutic implications. Gordon Keller, PhD, McEwen Centre for Regenerative Medicine, Canada, will describe modeling cardiac cell development from human pluripotent cells for use in toxicology and electrophysiology studies. Helen Blau, PhD, Stanford University, will describe her research to improve stem cell culture in the direction of stem cell fate and for drug screens.

In Neurodegeneration and Spinal Cord Injury, Paola Arlotta, PhD, Harvard University and a NYSCF-Robertson Stem Cell Investigator, will address the application of stem cells to understanding and possibly treating these debilitating diseases and conditions, and will describe investigations to direct reprogramming of neurons into different neuronal lineages. Lorenz Studer, MD, Memorial Sloan-Kettering Cancer Center, will discuss the potential stem cell technology holds in the treatment of Parkinson's disease. Despite past failures in the replacement of lost dopamine neurons, Dr. Studer will describe his novel protocols for the generation of these neurons for eventual use in clinical trials.

Rudolf Jaenisch, MD, The Whitehead Institute, will deliver the second keynote address of the day. Building on Shinya Yamanaka's paradigm-changing work in induced pluripotent stem (iPS) cell reprogramming, Dr. Jaenisch will discuss new methods to counter the generally low successful output of these cells. He will also summarize how targeted genome editing may help unleash the potential of iPS cells and embryonic stem cells for both the study of and therapy for disease.

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Scientists discuss stem cell discoveries at New York Stem Cell Foundation Conference

First Patient Treated in Cytori’s U.S. Cell Therapy Heart Failure Trial

SAN DIEGO & MINNEAPOLIS--(BUSINESS WIRE)--

Cytori Therapeutics (CYTX) announced the initiation of the FDA approved ATHENA clinical trial to investigate Cytoris cell therapy in patients who suffer from a severe form of refractory (untreatable) heart failure due to chronic myocardial ischemia. Cytoris cell therapy is based on a patients own adipose-derived stem and regenerative cells (ADRCs) processed by the Companys proprietary Celution System technology, making this the first FDA approved trial in the U.S. to evaluate ADRCs for cardiovascular disease. This first patient was treated by co-principal investigator Timothy Henry, M.D., Director of Research, at the Minneapolis Heart Institute Foundation in September and has undergone a seven day follow-up assessment. More details on the ATHENA trial may be found at http://www.theathenatrial.com.

Patients with refractory heart failure have no options except for heart transplant, for which there are few hearts available, said Dr. Henry. Cell therapy such as Cytoris has the potential to delay, halt, or even reverse this progression. We believe this is accomplished by the cells ability to promote angiogenesis and regulate the immune response to help revive damaged tissue that is alive yet not necessarily contributing to its fullest capacity toward the pumping ability of the heart.

ATHENA is a device-based, multi-center, prospective, randomized, double-blind PMA/IDE safety and feasibility (Phase I/II) trial that will enroll 45 patients in six centers in the U.S. Patients will be randomized to receive either Cytoris cell therapy (n=30) or an inactive placebo injection (n=15). All trial participants will undergo a minor liposuction procedure to remove adipose tissue. The adipose tissue will then be processed at the point-of-care with Cytoris proprietary system to separate and concentrate clinical-grade ADRCs. The treatment group will have a prescribed dose of the patients own ADRCs (0.4 million cells/kg body weight), which will then be injected into their damaged heart tissue using a minimally invasive catheter system.

Cytoris cell therapy has unique advantages compared to alternate cell sources such as bone marrow and peripheral blood, said Emerson Perin, M.D., Ph.D. of The Texas Heart Institute and co-principal investigator for ATHENA. Specifically, its a proprietary formulation that Cytori has optimized for vascular delivery and which contains an uncultured and mixed population of cells. As a result, this increases the number of cell types that potentially contribute to repair relative to a more homogenous population of cultured cells.

The trial will measure several endpoints, including peak oxygen consumption (VO2 Max). VO2 Max is an objective functional measurement that can be predictive of outcomes in heart disease, including mortality, and is commonly used as a primary determinant for qualifying patients for heart transplantation. Additional endpoints include perfusion defect, left ventricle end-systolic and diastolic volume and ejection fraction at six and 12 months. ATHENA will also evaluate medical economic factors such as rate of re-hospitalization and heart failure symptoms such as angina and quality of life at 12 months.

We believe Cytoris cell therapy will improve patient outcomes, said Marc H. Hedrick, M.D., president, Cytori Therapeutics. In ATHENA, investigators will be delivering a virtually off-the-shelf cell therapy comprised of a patients own cells, which is made possible by our technology. Using a patients own cells minimizes the risk of rejection or disease transmission compared to alternative therapies derived from donor cells and the virtually off-the-shelf nature allows the treatment to be accomplished in a single surgical procedure.

Cytori received approval from the FDA for its Investigational Device Exemption (IDE) application to begin ATHENA in January 2012 and the trial is currently expected to complete enrollment in mid-2013. In addition to Minneapolis Heart Institute Foundation, the Texas Heart Institute (Houston, TX) is actively screening patients under the direction of Emerson Perin, M.D., Ph.D., co-principal investigator for ATHENA, and James T. Willerson, M.D. Four additional centers are also expected to participate in the trial including:

Previously, Cytori reported six and 18-month safety and feasibility data from the PRECISE trial, a European clinical trial for this same indication. The PRECISE trial demonstrated a statistically significant improvement in VO2 Max in patients treated with Cytoris cell therapy compared to those treated with placebo. The Company is also conducting the ADVANCE trial, a European pivotal trial investigating the effect of Cytoris cell therapy in heart attack patients.

Refractory Heart Failure

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First Patient Treated in Cytori’s U.S. Cell Therapy Heart Failure Trial

StemGenex™ on Adult Stem Cell-Based Therapy for Multiple Sclerosis

LA JOLLA, Calif., Oct. 10, 2012 /PRNewswire/ --New research directions are being explored to find therapies for hard to treat diseases. One exciting new approach is the use of autologous Adult Stem Cells. Multiple Sclerosis (MS) is one of the many notable diseasesadult stem cell therapycould potentially impact. Multiple Sclerosis (MS) is a disorder in which an individual's own immune system attacks the 'myelin sheath'. The myelin sheath serves to protect the nerve cells within the body's central nervous system (CNS). The damage caused by MS may result in many types of symptoms including:

(Photo: http://photos.prnewswire.com/prnh/20121010/LA89802-INFO)

Currently there is no cure for MS, but MS stem cell therapiesattempt to slow the disease's progression and limit symptoms. Since adult stem cells have the ability to differentiate into many different types of cells, such as those required for proper functioning and protection of nerve cells, the use of adult stem cells for MS therapy could be of substantial value. Adult stem cells can be isolated with relative ease from an individual's own 'adipose' (fat) tissue. As a result, adult stem cell therapy is not subject to the ethical or religious issues troubling embryonic methods.

Encouragingly for MS treatment potential, scientific researchers have been studying the properties of adipose-derived stem cells. Their results from canine and equine studies suggest anti-inflammatory and regenerative roles for these stem cells. Also, further research findings suggest these adipose-derived stem cells can have specific immune-regulating properties. Markedly, clinical-based work conducted overseas has indicated that individuals suffering from MS could respond well to adipose-derived stem cell treatment, with a substantially improved quality of life.

The US based company, StemGenex, is pioneering new methods for using adipose derived adult stem cells to help in diseases with limited treatment options like MS. StemGenex has been conducting research with physicians over the last 5 years to advance adult stem cell treatment protocols for alleviating MS symptoms. StemGenex's proprietary protocol includes the use of a double activation process, which increases both the viability and the quantity of stem cells that are received in a single application.

To find out more about stem cell treatments contact StemGenex either by phone at 800.609.7795 or email at Contact@StemGenex.com.

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StemGenex™ on Adult Stem Cell-Based Therapy for Multiple Sclerosis

Cancer Stem Cell Therapy: Real Or Just Hype?

(Photo credit: Wikipedia) This morning, at the annual Biotechnology Industry Organization (BIO) Investor Forum in San Francisco, I'm hosting a panel discussion on the increasingly popular hypothesis that cancer stem cells (CSCs) play a vital role in tumor recalcitrance. The panel includes senior executives from three CSC-focused companies -- OncoMed, Stemline Therapeutics, [...]

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Cancer Stem Cell Therapy: Real Or Just Hype?

Fingers crossed at AIIMS after stem cell transplant for MS, first in country

Doctors at the All India Institute of Medical Sciences (AIIMS) have conducted a stem cell transplant on a multiple sclerosis (MS) patient. They believe this is the first recorded case of an autologous stem cell therapy where the donor and recipient are the same person for MS in the country.

Six months after the transplant, doctors say the spread of MS, an autoimmune disease that affects the brain and spinal cord, appears to have been contained but the therapy cannot be declared a success until the patient is monitored for at least a year.

International trials have demonstrated that this transplant can restrict the spread of the disease in advanced patients, and may even reverse symptoms in early stages in some patients.

Thirty-two-year-old Rohit Yadav, a commerce graduate from Delhi University, was diagnosed with the neurological disorder in 2010. In March this year, after trying all possible conventional treatment options, doctors at AIIMS finally decided on stem cell therapy.

Dr Kameshwar Prasad, professor of neurology who has been monitoring Yadav, said: The primary purpose of autologous stem cell transplant is to control the spread of lesions. We extract the patients own stem cells, treat and inject the stem cells back. Ever since the procedure, the patient has been completely stable. To the best of our knowledge, this is the first case of stem cell therapy for MS.

In MS, the bodys own immune system attacks the myelin sheath that coats nerves, slowly destroying the central nervous system. Symptoms range from numbness and weakness in the limbs to sudden loss of balance and coordination, blurred vision and paralysis and, at the most advanced stage, disability.

... contd.

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Fingers crossed at AIIMS after stem cell transplant for MS, first in country

Cellerant Awarded SBIR Contract Funding to Develop CLT-009 for Treatment of Thrombocytopenia

SAN CARLOS, Calif.--(BUSINESS WIRE)--

Cellerant Therapeutics Inc., a biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, announced today that it has been awarded a Small Business Innovation Research (SBIR) Phase 1 contract and a Phase 2 option from the National Cancer Institute (NCI) valued up to $1,683,503. The SBIR Contract funds the development of CLT-009, a first-in-class, human allogeneic Megakaryocyte Progenitor Cell therapy for the treatment of thrombocytopenia in cancer patients and allows the Company to conduct studies to enable an Investigational New Drug (IND) Application to be filed with the FDA in the next two years.

Thrombocytopenia is characterized as a significant reduction in the concentration of circulating platelets. Platelets are crucial in the process of coagulation to stop bleeding, and thrombocytopenia can increase the risk of severe bleeding in patients. It is becoming an increasingly common problem among oncology patients and a significant dose-limiting toxicity, especially in the treatment of hematological malignancies. Chemotherapy and radiation therapy are the most common causes of thrombocytopenia because the platelet-producing cells, megakaryocytes, and their precursors are highly sensitive to myelosuppressive cytotoxics and ionizing radiation. Thrombocytopenia typically occurs during the initial cycles of high-dose chemotherapy and radiation therapy, usually 614 days after administration. According to Datamonitor, the estimated incidence of cancer patients who suffer from significant chemotherapy-induced thrombocytopenia worldwide was approximately 200,000 in 2008.

Occurrence of severe thrombocytopenia may require dose reductions for chemotherapy regimens which can impact subsequent disease control and survival, especially in the treatment of hematological malignancies such as acute leukemia and high-risk myelodysplastic syndrome. Current treatment options include platelet transfusions which are costly and labor intensive and are associated with risks such as contamination and transmission of viral and bacterial infections. Recombinant human interleukin-11 is the only approved agent for chemotherapy induced thrombocytopenia but its use is limited and has only modest efficacy and significant side effects. CLT-009, a human Megakaryocyte Progenitor Cell product, would be an alternative treatment option, providing the critical megakayocyte progenitor cellular support to rapidly produce platelets in vivo and shorten the duration of severe thrombocytopenia following chemotherapy treatment.

We are delighted to receive this contract from NCI to support the development of our novel, off-the-shelf, platelet product and address a high unmet need, said Ram Mandalam, Ph.D., President and Chief Executive Officer of Cellerant Therapeutics. This contract allows us to not only leverage our experience in developing cellular therapies but also provides us with the ability to bring CLT-009 closer to the clinic. Our unique product portfolio, which now includes CLT-009, along with our CLT-008 myeloid progenitor cell product and our therapeutic antibodies targeting cancer stem cells, demonstrates our continued commitment to developing novel products for the benefit of cancer patients.

In addition to this SBIR contract, Cellerant has previously received grants from the National Institute of Health (NIH) in 2008 2010 to conduct research studies in platelet recovery which it has successfully completed. In its previous studies, Cellerant demonstrated that megakaryocyte progenitor cells were able to produce human platelets in preclinical models with in vivo functionality similar to that of normal human platelets.

This program is funded with Federal funds from the National Institute of Health, Department of Health and Human Services, under Contract No.HHSN261201200076C.

About CLT-009

CLT-009 is a unique, off-the-shelf, cryopreserved, cell-based therapy that contains human Megakaryocyte Progenitor Cells derived from adult hematopoietic stem cells that have the ability to mature into functional platelets in vivo. Cellerant is developing CLT-009 as an effective treatment for chemotherapy and radiation-induced thrombocytopenia in cancer patients.

About Cellerant Therapeutics

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Cellerant Awarded SBIR Contract Funding to Develop CLT-009 for Treatment of Thrombocytopenia

Stem Cell Researchers Share Nobel Medicine Prize

British researcher John Gurdon and Shinya Yamanaka from Japan have shared the Nobel prize for medicine or physiology.

The two pioneers of stem cell research were awarded the prize for transforming specialised cells into stem cells, which can become any other type of cell in the body.

John Gurdon discovered in 1962 that the specialisation of cells is reversible. In a classic experiment, he replaced the immature cell nucleus in an egg cell of a frog with the nucleus from a mature intestinal cell. This modified egg cell developed into a normal tadpole. The DNA of the mature cell still had all the information needed to develop all cells in the frog.

Shinya Yamanaka discovered more than 40 years later, in 2006, how intact mature cells in mice could be reprogrammed to become immature stem cells. Surprisingly, by introducing only a few genes, he could reprogram mature cells to become pluripotent stem cells, i.e. immature cells that are able to develop into all types of cells in the body.

These groundbreaking discoveries have completely changed our view of the development and cellular specialisation.

By reprogramming human cells, scientists have created new opportunities to study diseases and develop methods for diagnosis and therapy.

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Stem Cell Researchers Share Nobel Medicine Prize