Published on 10 November 2012 Hits: 112 Written by Jovee Marie N. Dela Cruz

The Department of Health (DOH) on Friday said that it has become necessary to issue regulations for stem cell therapy in the country. Health Secretary Enrique Ona said that guidelines for clinics offering stem cell therapy will be released immediately by the DOH and the Food and Drug Administration.

We will issue guidelines because here in the country we dont know where the stem cell offered by clinics come from, he said.

According to the DOH, stem cell therapy belongs to the category of advanced cell therapy, which includes biologics and blood. Many countries apply a risk-based approach to assess the quality, efficacy and safety of advanced cell therapy.

In many countries, stem cell is considered an investigational intervention, Ona said.

The DOH said that stem cell research employs both autologous (from same person) or allogenic (from another organism like an animal or another human cell or tissue sample) method.

Ona said that because there are many steps in the preparation of this lab and invasive procedure, there is a need to have a regulatory framework to protect Filipino citizens.

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DOH to regulate stem cell therapy in PH

April Flowers for redOrbit.com Your Universe Online

Conflicting studies were highlighted at this years American Heart Association Scientific Sessions meeting concerning stem cell therapy for heart attack patients.

The first study, from the University of Louisville and Brigham and Womens Hospital, reported holy grail results for a Phase I clinical trial: marked sustained improvement in all patients with zero adverse effects.

Roberto Bolli, M.D., of the University of Louisville and Piero Anversa, M.D., of Brigham and Womens Hospital presented data from their groundbreaking research in the use of autologous adult stem cells with patients who had previous heart attacks in a Late-Breaking Clinical Trial session.

The researchers report that all patients receiving the stem cell therapy showed improved heart function after two years, with an overall 12.9 absolute unit increase in left ventricular ejection fraction (LVEF). LVEF is a standard measure of heart function that shows the amount of blood ejected from the left ventricle during a heartbeat. They saw no adverse effects from the therapy. In fact, nine patients showed evidence of myocardial regeneration new tissue replacing formerly dead tissue killed by heart attack in MRI scans.

The trial shows the feasibility of isolating and expanding autologous stem cells from virtually every patient, said Bolli, who is the Jewish Hospital Heart and Lung Institute Distinguished Chair in Cardiology and director of the Institute for Molecular Cardiology in the Department of Medicine at UofL. The results suggest that this therapy has a potent, beneficial effect on cardiac function that warrants further study.

In all patients, cells with high regenerative reserve were obtained and employed therapeutically, said Anversa, professor of Anesthesia and Medicine at Brigham and Womens Hospital and Harvard Medical School. Our efforts to carefully characterize the phenotype and growth properties of the cardiac stem cells may have contributed to these initial positive results.

The Stem Cell Infusion in Patients with Ischemic CardiOmyopathy, or SCIPIO, trial was a randomized open-label trial of cardiac stem cells (CSCs) in patients who were diagnosed with heart failure following a myocardial infarction and had a LVEF of 40 percent or lower. A normal LVEF reading is 50 percent or higher.

The CSCs, referred to as c-kit positive cells because they express the c-kit protein on their surface, were harvested from 33 patients during coronary artery bypass surgery. The stem cells were then purified and processed so that they could multiply, and once an adequate number was produced about one million for each patient they were reintroduced into the region of the patients heart that suffered scarring during the heart attack.

At four months after infusion, the researchers report that LVEF increased from 29 percent to 36 percent for 200 patients. On average, the 13 control patients who did not receive a CSC infusion showed any improvement.

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Studies On Stem Cell Therapy After Heart Attack Show Mixed Results

By Philip C. Tubeza Philippine Daily Inquirer

The Department of Health (DOH) on Saturday warned those contemplating stem cell therapy against using stem cells from aborted babies and human embryos.

The DOH issued the statement as it reviewed the legal and technical specifications of stem cell therapy to come up with a regulatory framework.

The Philippine government will not allow the use of aborted fetuses or human embryos (as sources of stem cells). There is a need to ensure that the biological raw materials are documented and validated and follow infection-free procedures, the health department said.

There is also a need to know if the materials to be injected came from animal or human tissues, it added.

The DOH said the other fundamental areas of the regulatory framework would include the monitoring of the marketing claims by medical centers that offer stem cell therapy so that the claims stick within the boundaries of science as objectively as possible.

Credentials and procedures

The credentials of the scientists involved should also match the training, education and skills required for these procedures while good laboratory procedures should be observed in the preparation of the tissue and cells, the DOH said.

The centers to be regulated or accredited will have to show both positive and negative outcomes for a better handle of the predictors of success or failure from this intervention, it said.

The health department said there was a need for a regulatory framework because there were many steps in the preparation of stem cell therapies and the government had been receiving many queries about it.

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DOH warns against use of stem cells from aborted babies

NEW YORK, NY--(Marketwire - Nov 8, 2012) - Stem cell stocks have been gaining popularity among investors in 2012 as new and promising research continues to propel the industry forward. A study performed earlier this year at Johns Hopkins University has shown that stem cells from patients' own cardiac tissue can be used to heal scarred tissue after a heart attack. Five Star Equities examines the outlook for companies in the Biotechnology Industry and provides equity research on Aastrom Biosciences, Inc. ( NASDAQ : ASTM ) and Neostem Inc. ( NYSE : NBS ).

Access to the full company reports can be found at:

http://www.FiveStarEquities.com/ASTM

http://www.FiveStarEquities.com/NBS

A more recent study, also conducted at Johns Hopkins University, has showed that stem cells donated by strangers were as safe and as effective as the patient's own cells in repairing heart tissue. This is a key advancement for the treatment of heart attack with stem cells, as this possibly means stem cells could be stored for use just as blood is now.

"You could have the cells ready to go in the blood bank so when the patient comes in for a therapy -- there's no delay," said Dr. Joshua Hare of the University of Miami. "It's also cheaper to make the donor cells," as marrow from a single donor could provide enough cells for the treatment of up to 10 people.

Five Star Equities releases regular market updates on the Biotechnology Industry so investors can stay ahead of the crowd and make the best investment decisions to maximize their returns. Take a few minutes to register with us free at http://www.FiveStarEquities.com and get exclusive access to our numerous stock reports and industry newsletters.

Aastrom Biosciences is a leader in the development of patient-specific multicellular therapies for the treatment of severe, chronic cardiovascular diseases. Stem cell therapy is the infusion, injection or transplantation of whole cells into a patient for the treatment of a disease or condition.

NeoStem is a provider of adult stem cell collection, processing and storage services in the United States, enabling healthy individuals to donate and store their stem cells for personal therapeutic use. In addition, the company collects and stores cord blood cells of newborns which help to ensure a supply of autologous stem cells for the child should they be needed for future medical treatment.

Five Star Equities provides Market Research focused on equities that offer growth opportunities, value, and strong potential return. We strive to provide the most up-to-date market activities. We constantly create research reports and newsletters for our members. Five Star Equities has not been compensated by any of the above-mentioned companies. We act as an independent research portal and are aware that all investment entails inherent risks. Please view the full disclaimer at: http://www.FiveStarEquities.com/disclaimer

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Promising Stem Cell Research Driving Industry's Growth in 2012

RIO DE JANEIRO--(BUSINESS WIRE)--

CryopraxisTM/CellPraxis aims to start patient recruitment for its Phase III Refractory Angina Cell Therapy Brazilian arm clinical trial by the end of 2012 or early 2013. The phase IIA/B clinical trial study was completed in December 2011. These trials involved the use of a proprietary autologous stem cell formulation (MonocellTM) indicated for neoangiogeneses.

Safety and efficacy of this product was evaluated in patients with refractory angina, a no option disease condition, characterized by severe chest pain for which there is no efficient treatment available, says the President of both Companies, Eduardo Cruz.

ReACT, MonocellTMs derived product, showed evidence of safety and efficacy in our initial clinical trials. All patients included in this trial were classified as Class IV Angina in CCSAC* (the most severe class of chest pain). In the first group of patients, whose data was published**, there was a progressive and sustained improvement in angina symptoms, with 87.5% of the patients completing the clinical trial with a CCSAC score of 0 or 1.

Angina symptom relief began as early as 3 months post procedure with continuing improvement through the 18th month, suggesting that angiogenesis began early, and that it kept evolving 18 months after the procedure. Objective evaluation of stress myocardium perfusion (scintigraphic analysis), after 1 year of follow-up, gave indications of complete myocardial reperfusion in 75% of the patients, says Dr. Nelson Hossne, Medical Director of CellPraxis. Our conclusion was ReACT's specific cell formulation, MonoCell, had a direct correlation to myocardial neoangiogeneses.

About CryopraxisTM (www.cryopraxis.com.br) and CellPraxis (www.cellpraxis.com)

Located at Bio-Rio Biotech Cluster (Rio de Janeiro, Brazil), CryopraxisTM is the pioneer and the largest bank of umbilical cord blood in Brazil and has been in operation since 2001, with approximately 25,000 customers. CellPraxis is a bioengineering company that invests in research projects involving stem cell therapy. Some of these projects are conducted in partnership with institutions like the Federal University of Rio de Janeiro, Federal University of So Paulo, the University of South Florida and Saneron CCEL Therapeutics, Inc. (a USA based biotechnology company dedicated to stem cell research).

Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.

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Cardiac Cell Therapy Phase III Trial to Treat Refractory Angina

Public release date: 6-Nov-2012 [ | E-mail | Share ]

Contact: Steve Goodyear sgoodyear@mhif.org 952-807-8365 Minneapolis Heart Institute Foundation

MINNEAPOLIS, MN November 6, 2012 Administering autologous stem cells obtained from bone marrow either 3 or 7 days following a heart attack did not improve heart function six months later, reports a new clinical trial supported by the National Institutes of Health. The results of this trial, called TIME (Transplantation In Myocardial Infarction Evaluation), were presented by Jay Traverse, MD of the Minneapolis Heart Institute Foundation Tuesday, Nov. 6, at the 2012 Scientific Sessions of the American Heart Association in Los Angeles.

The results of this trial mirror a previous, related study (LateTIME) which found that autologous bone marrow stem cell therapy given 2-3 weeks after a heart attack did not improve cardiac recovery. Both TIME and LateTIME were carried out by the Cardiovascular Cell Therapy Research Network (CCTRN), sponsored by the NIH's National Heart, Lung, and Blood Institute.

"The data presented by TIME do much to advance stem cell therapy research," said Jay Traverse, MD of the Minneapolis Heart Institute Foundation and Principal Investigator of this study. "While this study did not provide a demonstrated cardiac benefit after six months, we still learned a great deal. Together, TIME and Late TIME have shown that stem cell therapy is safe, and they have set a baseline in terms of quantity of stem cells, type of stem cells, and severity of heart attack."

TIME enrolled 120 volunteers (avg. age 57) between July 2008 and February 2011; the participants all had moderate to severe impairment in their left ventricle and had undergone coronary stent placement as treatment for the heart attack. The participants were randomly assigned to one of four groups: day 3 stem cell, day 3 placebo (inactive cells), day 7 stem cell, or day 7 placebo. The CCTRN researchers developed a method of processing and purifying the stem cells from the bone marrow of each volunteer to ensure everyone received a uniform dose (150 million stem cells).

Heart improvement was assessed six months after stem cell therapy by measuring the percentage of blood that gets pumped out of the left ventricle during each contraction (left-ventricular ejection fraction, or LVEF). The study found no significant differences between the change in LVEF readings at the six month follow-up in either the Day 3 or Day 7 stem cell groups compared with placebo or with each other; every group showed about a 3 percent improvement in LVEF. However, the researchers found that younger patients randomized to Day 7 had greater improvement in their LVEF compared to their placebo counterparts

"The lack of six-month improvement seen for TIME and, prior to that, LateTIME, does not mean stem cell therapy is not a viable post-heart attack strategy," said Traverse. "Because we have this data we can start to address some parameters; for example this therapy may work better in younger people, or maybe we need to use cells from healthy volunteers (allogeneic) since their cells may provide greater therapeutic benefit. There will also be upcoming studies using novel cell types which we look forward to using in future clinical trials."

###

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Stem cell therapy using patient's own cells after heart attack does not enhance cardiac recovery

UPDATE on Stem Cell Therapy

7 November 2012

The Department of Health (DOH) saw the necessity to cover regulations for Stem Cell therapy. Stem Cell therapy belongs to the category of Advanced Cell therapy which includes biologics and blood. Many countries around the world apply a risk-based approach to assess the quality, efficacy and safety of advanced cell therapy. In many countries, Stem Cell is considered an investigational intervention.

Stem Cell research employs both autologous (from same person) or allogenic (from another organism like animal or another human cell or tissue sample) method. Because there are many steps in the preparation of this lab and invasive procedure, there is therefore need to have a regulatory framework to protect Filipino citizens.

Important questions were asked: is there proof of concept in animal trials where stem cell can then be applied in humans? Is there a way to ensure quality and purity of the raw materials? How safe is the procedure? How many did not benefit from the procedure? If this were investigational procedure, how will human subjects be protected?

Sec. Enrique Ona convened a consultative working task force to provide recommendations on how to proceed in the early part of the year in response to queries and mushrooming of centers here and overseas. This led to the creation of a regulatory task force to oversee the appropriate steps that will ensure quality, efficacy and safety documentation of this intervention.

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UPDATE on Stem Cell Therapy 7 November 2012

cord blood center | Cord Blood Transplantation - A Life Savior Technique
http://www.cordbloodrecommendation.com Storing your babies blood is painless, and causes no harm or pain to the child or mother. Anything that can help cure illnesses and several genetic diseases is worth at least researching and contemplating because you really do never know when you may need it. This type of stem cells is found in baby cord blood and adult bone marrow. Umbilical blood banking provides the ideal stem cell match should a patient require stem cell therapy in their lifetime. Hence opt for cord blood storage banks that can show proof of successful transplants from the cord blood units they have stored in order to avoid rude shocks. If you are an expecting mother, you can look for a bank or designated donation hospital in your community. In cases of leukemia, stem cells can be used to generate healthy blood and fight off the cancer cells in the body. Furthermore, collecting umbilical cord blood has no controversy since the process does not cause the destruction on the embryos and fetus. ""Leukemia is a type of cancer that begins from those tissues in the body that form blood. Ultra-modern cord blood banking technologies induce multiplication of cord blood stem cells by ex vivo expansion. Last but not the least, if you do not want to store the blood for your personal usage in any of these banks you can also donate it to the Medical Institutes for research purposes. Stem cells, researchers discovered, could cure many diseases such as leukemia and help others such as ...From:Implantes DentalesViews:1 0ratingsTime:01:31More inTravel Events

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cord blood center | Cord Blood Transplantation - A Life Savior Technique - Video

FAQ-10 of 19: Can Stem Cells Cause Cancer From Stem Cell Therapy?
youtu.be People ask us if stem cell therapy can CAUSE cancer, and they are wise to be wary, but stem cell therapy has been proving effective AGAINST cancer, and has not cause any known cases of cancer to-date. For more personalized information, visit StemCell-Asia.info now.From:Karridine1Views:1 0ratingsTime:01:06More inPeople Blogs

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FAQ-10 of 19: Can Stem Cells Cause Cancer From Stem Cell Therapy? - Video

FAQ-11 of 19: For Stem Cell Therapy, Why Thailand #39;s Licensed Stem Cell Treatments?
youtu.be You may wonder why coming to Thailand is a better investment of time, energy and resources, so here are some answers. For more personalized information as to how your condition might respond to stem cell therapy, go to the Apply Now page and send in copies of your medical records with an Application for Consideration. StemCell-Asia.infoFrom:Karridine1Views:0 0ratingsTime:01:16More inPeople Blogs

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FAQ-11 of 19: For Stem Cell Therapy, Why Thailand's Licensed Stem Cell Treatments? - Video

FAQ-14 of 19: Do We Provide a Guarantee for Stem Cell Therapy?
youtu.be This video addresses the ethical, practical aspects of a #39;guarantee #39; for stem cell therapy or stem cell treatments. For more detailed information concerning guarantees, stem cell therapy and your particular problem, visit bit.ly today.From:Karridine1Views:0 0ratingsTime:01:15More inPeople Blogs

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FAQ-14 of 19: Do We Provide a Guarantee for Stem Cell Therapy? - Video

Arthritis
Call: 305-695-7777 For More Information Arthritis has been something historically very hard to cure, but we maybe one step closer to a cure by using stem cell therapies instead of steroids and other types of medications. At Miami Beach Foot and Ankle Surgery we have been utilizing PRP (platelet rich plasma) therapy as well as amniotic stem cell therapy, which is important in the world of arthritis.From:MiamiFootSurgeryViews:11 0ratingsTime:01:12More inHowto Style

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Arthritis - Video

Muscular Dystrophy Before and After Stem Cell Therapy
He took stem cell therapy at NeuroGen. Previously when he was climbing stairs, he was widening steps and climbing stairs. And he was taking more time, now he is taking less time. Climb stairs straight. Previously during sit to stand, he was taking support of hands and was coming up, but now he is not taking support. Previously when he was sitting on floor, he was facing in coming up and facing problem in walking few steps. But after stem cell therapy he can walk normally now. Now changes are seen. Stem Cell Treatment done at Neurogen ,Brain Spine Institute, Surana Sethia Hospital and Research Centre, Suman Nagar, Sion-Trombay Road, Chembur,Mumbai-71. Website -- http://www.neurogen.in http://www.stemcellsmumbai.com Tel: - +91 9920 200400, 022-25283706From:neurogenbsiViews:0 0ratingsTime:00:37More inScience Technology

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Muscular Dystrophy Before and After Stem Cell Therapy - Video

The Patients of Angeles Health International
What our patients have to say about their experiences at Angeles Health International. All patients were treated for different conditions, in separate departments throughout our facilities. Angeles Health International offer cutting edge care, procedures and treatment in the following areas: Weight Loss Surgery - http://www.weightlossmex.com Stem Cell Therapy - http://www.stemcellmx.com Multiple Sclerosis Treatment - http://www.ccsvi.mx Effective Chemotherapy-free Cancer Treatment - http://www.cancertreatmentmx.com Visit the Angeles Health International website here: http://www.angeleshealth.com There are a team of healthcare professionals waiting to hear from you. Contact Angeles Health International toll free on: 1.866.668.9263From:AngelesHealthViews:0 0ratingsTime:03:06More inScience Technology

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The Patients of Angeles Health International - Video

When he was only 43, Peter Harrison had a severe heart attack that left him suffering from the symptoms of a damaged heart: shortness of breath, chest pain and increased risk of another heart attack. An otherwise healthy commercial real estate agent from Key Biscayne, Harrison was in and out of the hospital for 20 years treating his heart condition until last year when doctors at the University of Miami Miller School of Medicine injected his heart with stem cells as part of a study.

Three weeks later, he was hiking the steep hills of the U.S. Virgin Islands, keeping up with his wife.

There was no chest pain and I was not out of breath it was quite a revelation, he said. I was hoping that the damaged part of my heart would come back to life, and the indication is that it has.

The study, which was funded by the National Institutes of Health and published in the Journal of the American Medical Association this week, found that stem cell injections into the heart muscle reduced scar tissue by one third, built up healthy heart tissue and remodeled the spherical shape of the damaged heart to look more like a football-shaped healthy heart.

Dr. Joshua Hare, the director of the UM Interdisciplinary Stem Cell Institute and the lead author of the study, said the stem cells cells that are not fully formed and have the potential to become different kinds of cells internalize information from their milieu to know what to become.

We think the cells respond to environmental cues to determine how they divide and differentiate, he said. The stem cells used in this study were taken from bone marrow and have a limited repertoire of possibility, meaning they are more easily transformed into bone or muscle than blood or brain.

Half of the 30 men enrolled in this small pilot study at UM and Johns Hopkins University received injections of their own stem cells, while the other half got stem cells from a third party donor. Harrison was in the group that got donated stem cells. There are no compatibility requirements for stem cell donors as there is with blood and bone marrow, and one donor can provide enough stem cells for many, many people, Hare said.

This is an elegant treatment in that it doesnt transgress any ethical boundaries, Hare said, alluding to the controversy surrounding the use of stem cells from human embryos. You dont need to create a donor bank, its easy to implement and relatively inexpensive.

Stem cell therapy, a growing area of research, drew attention earlier this year when the Nobel Prize in Medicine went to John B. Gurdon of the University of Cambridge in England and Shinya Yamanaka of Kyoto University in Japan for their work in turning mature cells back into pluripotent stem cells that have the potential to become other types of cells. Hare said the UM study was essentially the opposite rather than reduce mature cells to stem cells, these injections of stem cells differentiated into healthy heart tissue.

Participants were injected with 10 doses of stem cells delivered by a catheter with a cork-screw tip that bored into the heart muscle between damaged and healthy tissue. The randomized trial found best results with the patients who received the smallest dosage 20 million total stem cells compared to other doses of 100 million or 200 million. Further studies are required to determine the ideal dosage for heart patients, and also to explore other applications for this kind of treatment.

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In University of Miami study, stem cell injections repair damaged heart

FAQ-11 of 19: Why Have Stem Cell Therapy in Thailand #39;s Stem Cell Clinic?
youtu.be A few gentle suggestions on why visiting the only European-licensed stem cell clinic in Thailand is a better choice for time, optimum results and budget. For more detailed answers about Thailand #39;s one licensed stem cell clinic, visit bit.lyFrom:Harvey WallbangerViews:0 0ratingsTime:01:16More inNonprofits Activism

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FAQ-11 of 19: Why Have Stem Cell Therapy in Thailand's Stem Cell Clinic? - Video

FAQ-10 of 19: Do Stem Cells Cause Cancer In Stem Cell Therapy?
youtu.be People ask us if stem cell therapy can CAUSE cancer, and they are wise to be wary, but stem cell therapy has been proving effective AGAINST cancer, and has not cause any known cases of cancer to-date. For more personalized information, visit StemCell-Asia.info now.From:Harvey WallbangerViews:0 0ratingsTime:01:06More inScience Technology

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FAQ-10 of 19: Do Stem Cells Cause Cancer In Stem Cell Therapy? - Video

FAQ-12 of 19: Are Our Stem Cell Doctors Qualified for Stem Cell Therapy?
youtu.be The straight answer to this question might surprise you, but only if you think stem cell therapy is something that was approved for certain patients THIS year. And for more surprising, encouraging details on stem cell therapies and your particular case, visit bit.ly today.From:Harvey WallbangerViews:0 0ratingsTime:00:55More inPeople Blogs

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FAQ-12 of 19: Are Our Stem Cell Doctors Qualified for Stem Cell Therapy? - Video

FAQ-13 of 19: What Stem Cell Therapy Will Be MY Stem Cell Treatment?
youtu.be This seeks to answer the #39;what do I need for ME? #39; question, although it is a personal question not readily answerable online, so for your questions, go to bit.lyFrom:Harvey WallbangerViews:0 0ratingsTime:01:28More inEducation

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FAQ-13 of 19: What Stem Cell Therapy Will Be MY Stem Cell Treatment? - Video

FAQ-14 of 19: Do We Offer a Guarantee for Our Stem Cell Therapy?
youtu.be Yes, a reasonable guarantee is provided, and you can learn more of it in this video. When you want more than this, visit bit.ly for personalized details of how stem cell therapy can benefit you.From:Harvey WallbangerViews:0 0ratingsTime:01:15More inPeople Blogs

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FAQ-14 of 19: Do We Offer a Guarantee for Our Stem Cell Therapy? - Video