The Alliance for Regenerative Medicine Statement on Use of Cell Therapies Not Approved by the Federal Drug …

WASHINGTON, DC--(Marketwire -03/05/12)- The Alliance for Regenerative Medicine issued the following statement today: "An article about stem cell treatments taking place in Texas published by Nature last week is extremely troubling. The article suggests that patients are being administered stem cell treatments that have not been systematically demonstrated to be safe and effective therapies through the established FDA regulatory process.

"Cell therapy treatments, including those using adult stem cells, hold the promise of providing patients with treatments and cures for numerous diseases and disabilities. However, FDA regulation is key to ensuring that the treatments available to patients are safe and effective.

"The Alliance for Regenerative Medicine (ARM), a non-profit organization whose mission is to promote increased funding and development of regenerative medicine products, believes cell therapy and regenerative medicine products, including autologous cell therapy products, must go through the rigorous safety testing that is part of the FDA regulatory process before they can be marketed to the public. These regulations are designed to promote safe collection, manufacture, storage, and use of human cells, and cellular and tissue based products. ARM members comply with these rules because they know that FDA oversight helps to prevent patients from exposure to potentially unsafe products.

"We urge all companies developing stem cell treatments to follow FDA rules governing research and product development. ARM remains committed to working with all stakeholders to ensure that safe and effective products reach patients as soon as possible."

About The Alliance for Regenerative Medicine (ARM) The Alliance for Regenerative Medicine (ARM) is a Washington, DC-based non-profit organization that promotes legislative, regulatory, reimbursement, and financing initiatives necessary to facilitate access to life-giving advances in regenerative medicine. ARM also works to increase public understanding of the field and its potential to transform human healthcare, and provides services to support the growth of its member companies and organizations. To learn more about ARM or to become a member, visit http://www.alliancerm.org.

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The Alliance for Regenerative Medicine Statement on Use of Cell Therapies Not Approved by the Federal Drug ...

Nuvilex Announces Major Breakthrough in Stem Cell Research

SILVER SPRING, Md.--(BUSINESS WIRE)--

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, released information today about the companys cell encapsulation technology and the breakthrough in stem cell research which overcomes specific fundamental challenges faced in stem cell therapyhost rejection and migration of implanted cells away from the target site.

Stem cell therapy is believed by many medical researchers as holding a key to treating cancer, Type 1 diabetes mellitus, Parkinson's disease, Huntington's disease, Celiac Disease, cardiac failure, muscle damage, neurological disorders, and other chronic, debilitating diseases. There are presently >1,400 registered trials using stem cells that are recruiting patients (ClinicalTrials.gov). The encapsulation technology being advanced allows live stem cells to be implanted into robust, flexible and permeable capsules where they can replicate inside the capsules at the target site free from attack by the bodys immune system and free to undergo natural changes to become the appropriate cell type needed.

The Goldman Small Cap Research report, issued February 29, 2012, noted some inherent difficulties encountered in stem cell treatments, such as keeping stem cells alive for significant periods of time, potential rejection of the cells and subsequent destruction by the recipients immune system, and the migration of the stem cells away from the critical treatment site, while making a distinction that the Companys cell encapsulation technology overcomes these concerns.

The report also accurately recognized, Cells encapsulated in SG Austrias porous beads remain alive for long periods of time in humans, surviving intact for at least two years. Once encapsulated, cells are protected from the bodys immune system. Furthermore, encapsulated cells remain within the beads and do not migrate out of the beads to other sites in the body.

In assessing the overall importance of this technology to Nuvilexs overall business model, Goldman pointed out, The Companys acquisition of the Cell-in-a-Box approach along with the expertise of SG Austria could significantly advance the implementation and utilization of stem cells for a host of debilitating diseases and conditions, in addition to being used to target cancer cells, thus making it a uniquely valuable commodity. We believe that by partnering with leading players in the field, Nuvilex could find that companies with deep pockets would be happy to collaborate or license the delivery system and engage in further research which could result in meaningful development and licensing revenue.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, added, There is a broad range of expanding research supporting the use of stem cells to treat a variety of human diseases and conditions. Our technology allows for precise maintenance and localization of stem cells, preventing their loss from the critical area of need, that will enable us to potentially create miniature organs at specific sites and as a result we believe greater utilization of those stem cells at the site for their intended purpose, once implanted. As stem cell treatments advance, we expect Nuvilex to be at the forefront of developing new, significant, life changing therapies.

For a detailed review of the research report and valuation methodology, investors are directed to the Goldman Research Report.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of clinically useful therapeutic live encapsulated cells and services for encapsulating live cells for the research and medical communities. Through our effort, all aspects of our corporate activities alone, and especially in concert with SG Austria, are rapidly moving toward completion, including closing our agreement. One of our planned offerings will include cancer treatments using the companys industry-leading live-cell encapsulation technology.

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Nuvilex Announces Major Breakthrough in Stem Cell Research

BioTime and Aastrom Biosciences — Stem Cell Research Making Breakthroughs

NEW YORK, NY--(Marketwire -03/05/12)- February was a challenging month for stem cell stocks. TickerSpy's Stem Cell Stocks Index (RXSTM) has slipped nearly 13 percent over the last month -- underperforming the S&P 500 by close to 17 percent over that time frame. Despite the drop in investor optimism, new and promising research continues to propel the industry forward. Five Star Equities examines the outlook for companies in the Biotechnology industry and provides equity research on BioTime, Inc. (AMEX: BTX - News) and Aastrom Biosciences, Inc. (NASDAQ: ASTM - News). Access to the full company reports can be found at:

http://www.fivestarequities.com/BTX

http://www.fivestarequities.com/ASTM

A new study 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. "This has never been accomplished before, despite a decade of cell therapy trials for patients with heart attacks. Now we have done it," Eduardo Marban, director of the Cedars-Sinai Heart Institute and one of the study's co-authors, said in a statement. "The effects are substantial."

In another study, researchers led by Jonathan Tilly, director of the Vincent Center for Reproductive Biology at Massachusetts General Hospital, argue they've discovered the ovaries of young women harbor very rare stem cells capable of producing new eggs.

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, Inc., a regenerative medicine company, engages in developing autologous cell therapies for the treatment of severe and chronic cardiovascular diseases.

BioTime, Inc. primarily focuses on regenerative medicine, which refers to therapies based on human embryonic stem (hES) cell and induced pluripotent stem (iPS) cell technology designed to rebuild cell and tissue function lost due to degenerative disease or injury. The company recently elected to market progenitors of muscle stem cells bearing hereditary diseases. BioTime will produce the products from five human embryonic stem (hES) cell lines from Reproductive Genetics Institute (RGI) of Chicago, Illinois.

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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BioTime and Aastrom Biosciences -- Stem Cell Research Making Breakthroughs

Company's new partnership will bring jobs to Jessamine Co.

NICHOLASVILLE A partnership with a larger distribution company means that MediVet America will bring more jobs to Jessamine County.

MediVet, headquartered in Nicholasville, is a two-year-old company that makes stem-cell kits for the treatment of animals. Late last month, MediVet announced its partnership with Butler Schein Animal Health to sell and distribute stem-cell kits to veterinarians around the world.

That means a bigger sales force pitching MediVet's products and that, in turn, means the company will hire more people and bring manufacturing to Jessamine County, said MediVet CEO Jeremy Delk. The company's products are now manufactured in Australia.

MediVet employs 12 full-time people in Nicholasville, and Delk anticipates that Jessamine County will gain five to seven sales jobs and 10 to 20 manufacturing jobs in the "next three to six months."

Butler Schein, headquartered in Dublin, Ohio, sells all kinds of equipment and supplies to veterinarians, and has nearly 400 sales representatives. That sales force means "more feet on the ground" to tout MediVet's products and services to veterinarians, Delk said.

Stem cells are simple cells in the body that can develop into any one of various kinds of cells, such as blood cells, skin cells, etc. They can regenerate new cells to replace or repair damaged tissue.

The stem cells used in veterinary medicine are not embryonic, which have attracted controversy in recent years, but are taken from "adipose" or the fat tissue of an adult animal.

The kits that MediVet sells enable veterinarians to remove a small sample of fat, separate the stem cells, then activate and inject them back into affected areas.

While equine vets are using stem cells to treat horses for soft-tissue problems and joint diseases, the small-animal market is much bigger, Delk said.

There are 170 million dogs and cats in the United States, and 25 percent of them will suffer from sort of degenerative disease like osteoarthritis, hip dysplasia, or damage to joint cartilage, ligaments and tendons.

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Company's new partnership will bring jobs to Jessamine Co.

Cell find boosts liver disease hope

Boosting the production of certain cells could help treat liver disease, new research has suggested.

Researchers at the Medical Research Council (MRC) Centre for Regenerative Medicine at the University of Edinburgh said they have discovered how to enhance the production of key cells needed to repair damaged liver tissue. The research could help develop treatments for diseases such as cirrhosis or chronic hepatitis.

Scientists hope their work could eventually ease the pressure on waiting lists for liver transplants. Researchers said that when the liver is damaged it produces too many bile duct cells and not enough cells called hepatocytes, which the liver needs to repair damaged tissue.

They found they could increase the number of hepatocyte cells - which detoxify the liver - by encouraging these cells to be produced instead of bile duct cells. Understanding how liver cells are formed could help to develop drugs to encourage the production of hepatocytes to repair liver tissue.

Professor Stuart Forbes, associate director at the MRC, who is a consultant hepatologist and was the academic leader of the study, said: "Liver disease is on the increase in the UK and is one of the top five killers. Increasing numbers of patients are in need of liver transplants, but the supply of donated organs is not keeping pace with the demand.

"If we can find ways to encourage the liver to heal itself then we could ease the pressure on waiting lists for liver transplants."

The production of hepatocyte cells was increased by altering the expression of certain genes in early stage liver cells. The university said that liver disease is the fifth biggest killer in the UK with almost 500 people waiting for a liver transplant, compared with just over 300 five years ago.

Dr Rob Buckle, head of regenerative medicine at the MRC, said: "Liver transplants have saved countless lives over the years, but demand will inevitably outstrip supply and in the long term we need to look beyond replacing damaged tissues to exploiting the regenerative potential of the human body.

"The MRC continues to invest heavily across the breadth of approaches that might deliver the promise of regenerative medicine, and this study opens up the possibility of applying our increasing knowledge of stem cell biology to stimulate the body's own dormant repair processes as a basis for future therapy."

The study is published in the journal Nature Medicine. It was carried out in collaboration with the University's MRC Centre for Inflammation Research, the Beatson Institute for Cancer Research in Glasgow and the KU Leuven in Belgium.

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Cell find boosts liver disease hope

It's not pulp fiction

Stem cell therapy is poised to become the next big thing in the treatment of major diseases. Even those extracted from dental pulp can be preserved for future use

Watching his five-year-old pull at his loose tooth, dad Shekar remembered something he had read in a dental clinic. Stem cells from teeth, called dental pulp stem cells (DPSCs) could be preserved and retrieved to treat his son if he had a major ailment in future. Stemade, a private company, would arrange to collect DPSCs through its Smile Clinics and store them in state-of-the-art labs in several cities across the country. His thought: Stem cell technology is the next big step in medical treatment. Banking SCs is medical bio-insurance for his kid.

Stem cell therapy didn't jump out of a box yesterday. We've heard of it being used in treating leukaemia. Patients with spinal cord injury have spent huge sums on it hoping to get up and walk. Some ask: If a house lizard can grow back its tail, why can't we get our systems to re-start with a million multiplying stem cells?

Kinds of cells

The best cells for banking are embryonic cells which are programmed to develop and grow. But harvesting these is banned. Ethical issues, you know. Adult SCs beyond the embryonic stage are classified as haematopoietic (from umbilical cord blood and bone marrow) and mesenchymal (tissues and organs). While haematopoietic cells are used in the treatment of blood-related diseases such as haemophilia, blood cancer and skin troubles, tissue cells are tried on all problems other than these. HSCs are collected only from the umbilical cord and bone marrow. Tissue cells are taken from many body sources such as bone marrow, placenta, menstrual blood, cornea, outer layer of the heart, liposuction waste and teeth pulp.

Among these DPSCs are perhaps the best option, says Shailesh Gadre, MD, Stemade Biotech. We all lose our milk teeth and cell extraction here is almost painless. As for the permanent teeth, we can harvest the pulp when people have to lose them for orthodontic (cosmetic) reasons, as when braces are fixed or teeth are extracted because of poor positioning. Of course, they need to be free of caries and other dental infections.

But as we age, our cells age too, so DPSCs are best extracted and preserved when we're very young, when the cells are virile and robust. DPSCs have extraordinary doubling properties that give them a huge advantage over other stem cells, says Dr. Julian Deepak, Medical Advisor, Stemade. They are derived from the same source as nerve cells, with the same capacity as neuron cells, making them a better option for treating Parkinson's, Alzheimer's and muscular dystrophy. Work is on to see their effectiveness in curing diabetes.

Back to the kid's tooth. After the dad's call, a dentist from Stemade will check if Milan's tooth is free of disease. At a Smile Clinic he will extract it and take a blood sample. The dentist will then place the tooth in a specially-designed vial of antibiotic solution. The vial will be packed in ice-gel to keep the temperature low during transport. At their lab (which I visited) in suburban Chennai, a visual inspection is done, the tooth is flooded with anti-bacterial solution and broken open. The pulp is extracted, divided into parts for quality control and sterility (aerobic/anaerobic) tests. The processing is done in zero-contamination conditions and the cells are put in 5 different vials and placed in the vapour phase of liquid nitrogen for cryo-preservation. It is complete, patented technology. The cells are stored in raw format and can be retrieved when needed. Shekar gets a certificate and a CR Management number which will be part of his son's medical records.

These are your own (autologous) cells and will need no matching should you need them for treatment of tissue-and-organ-related diseases such as spinal cord/bone/liver/cartilage regeneration, diabetes, eye-care, etc., says Shailesh. Adds Dr. Julian, Now for most diseases we just do maintenance therapy. With their regenerative property, stem cells will cure diseases in the future.

Fine, but for a few details. One, is the banking fee? Yes, you have to pay for the banking facility, but we can help you with EMIs, says Shailesh. Subsidies are given to the poor as part of CSR. We want to reach as many households as possible. Others are the right to will it and fool-proof identification of the cells. We may store DPSCs at six and may need them at sixty.

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It's not pulp fiction

Stem-cell pawns

To read Hard Cell by Mayrav Saar (PostScript, Feb. 26), one would think the only form of stem-cell therapy is the embryo-destroying kind. There wasnt a single mention of non-embryonic adult stem cells.

One attraction of embryonic versus non-embryonic research for some is political the chance to stick it to pro-lifers. But it grieves me to see ailing people used as pawns in this culture war and being denied the possible benefits of adult stem-cell research.

Flushing such an idea down the memory hole, as you help do with this article, is against the spirit of scientific inquiry.

Bob Hunt, Hillsborough, NJ

Wrong on the right

If social conservatives had won out in history, women would not be able to vote and we would still have slavery (Why Social Issues Matter, Jeffrey Bell, PostScript, Feb. 26).

Their thinking denigrates the role of science and promotes antiquated religious beliefs. Many of the causes taken up by social conservatives have been seen to be wrong in light of later progressive thought.

While social conservatives say some good things, history has shown that their views work against American freedoms an obscurantism that continues today.

Jeffrey Bell should balance his thought with facts and not be led blindly by evangelicals.

Eduardo Rodriguez, Corona

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Stem-cell pawns

Texas family turned to Bonita stem cell doctor, but 5-year-old died before 'miracle'

Jason Bell

BONITA SPRINGS Jimmy and Jennifer Bell were scrambling to save their 5-year-old-son, Jason, last fall.

Shell-shocked with a diagnosis that their youngest child had primary pulmonary hypertension, a rare lung disorder, they decided to take a chance. If not, a heart-lung transplant would be their son's only chance.

They put their trust in a Southwest Florida cardiologist, Dr. Zannos Grekos, more than 1,000 miles from their Texas home. They learned Grekos performs an experimental stem cell therapy that possibly could help. That's despite a lack of clinical studies and scientific papers.

The U.S. Food and Drug Administration hasn't approved stem cell therapy despite a buzz of optimism of its potential for repairing damaged tissue.

"I was willing to do anything to give my son a fighting chance," said Jimmy Bell, 43, who owns a landscaping company in Keller, a suburb of Fort Worth. "When you are given no other option, you've got to try something."

The treatment would involve a trip to Bonita Springs where Grekos has his practice, Regenocyte; a trip to the Dominican Republic where the treatment would be done, and an up-front payment of $57,000.

"They looked at his medical records first. They didn't know if they could treat him," Bell said. "Once they agreed to treat him, I talked to Grekos. It was the greatest news in my life. I broke down. I just knew this was going to be the miracle to save his life."

* * * * *

The family wired the money in late October 2011 to a Regenocyte account in the Dominican Republic, according to a copy of the paid invoice furnished to the Daily News.

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Texas family turned to Bonita stem cell doctor, but 5-year-old died before 'miracle'

Stem cell study ‘should aim at innovation in treatment’

By Bonnie James Deputy News Editor The stem cell and regenerative therapy programme, constituting a major part of research at Qatar Cardiovascular Research Centre (QCRC), has important clinical and scientific implications, co-chairman Prof Sir Magdi Yacoub has said. He was giving a keynote presentation at the Qatar International Conference on Stem Cell Science and Policy 2012, which concluded on Thursday at Qatar National Convention Centre. Myocardium (the muscular tissue of the heart) regeneration and tissue engineering and valves tissue engineering are among the focal areas at QCRC, which aims to establish in Qatar an internationally competitive centre of excellence for cardio-vascular research. QCRC, which has a heart muscle lab and a tissue engineering, regeneration lab, works with a mission to maintain a translational focus, relevant to the development of health policy and practice, and provide opportunities for capacity building, professional development and research collaborations in Qatar. It is also meant to provide opportunities for biotechnology development in Qatar and contribute to cardio-vascular health in the developing world through improved knowledge base, capacity building and development of appropriate tools and strategies focused on poorer countries. Cardio-vascular diseases (CVDs) kill 17mn people per year globally and there is particularly high incidence in the Middle East and Gulf region, Prof Yacoub pointed out. The incidence of CVDs is three times more in the region than in the UK, the US or Europe. Smoking, one of the main reasons for CVDs, is also increasing in the eastern Mediterranean region compared to the Americas. There is a significant lack of clinical, epidemiological and genetic data from this region and an overwhelming need exists to better understand epidemiology and disease mechanisms of CVDs. Research should then be linked to development of appropriate tools and strategies to strengthen prevention, diagnosis and treatment, he said. Pointing out that heart transplant options for those suffering from severe heart failure are becoming increasingly rare, Prof Yacoub observed that the number of donor hearts is going down globally. While we used to do up to 130 heart transplants a year at Royal Brompton and Harefield Hospitals in the UK in the late 80s, now we would be lucky to do 20, he said while emphasising the need to focus more on the reversibility of heart failure. Few recent drug trials have shown evidence of minor reverse remodelling and there have been near-complete reversal of almost every change in myocardium in some patients. There are unprecedented opportunities to unravel the secrets of heart failure at cellular and molecular levels, he stressed.

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Stem cell study ‘should aim at innovation in treatment’

Pat was Diagnosed with “CMT” Disease and was Given a Second Chance with a Stem Cell Treatment

Pat receive a life altering Stem Cell Treatment with the help of World Stem Cells, LLC. Pat went from couch bound to walking 1.5 miles on country dirt road, climbing stairs, gardening and playing piano all thanks to a stem cell treatment.

(PRWEB) March 03, 2012

Pats neurological disorder is hereditary, and the official position of the National Institute of Neurological Disorders and Stroke is that CMT has no cure. Decades ago, Pat had gone to a neurologist for electromyography, or EMG. The purpose of the procedure was to evaluate her muscle function, and it involved painful needles and days of muscle soreness after each session. Pats neurologist had refused to tell her the results because he said that she would just give up if she knew how bad they were. At this point, Pats symptoms were so crippling and unbearable that she contacted World Stem Cells, LLC worldstemcells.com to explore stem cell treatment as an option. She knew that the procedures were still being developed and experimental, and that they came with no guarantees. She remained interested in learning more and becoming educated on the options presented. At the time, she was unable to walk without a four-leg quad cane, and air and car travel were exhausting and caused unbearable pain. Pat has a long history of surgeries and was told that further surgeries would not assist her. She decided that she was not interested in any treatment that involved surgery with incisions, which is an aggressive approach and would demand recovery time. Stem cell therapy met her requirements of being minimally uncomfortable, requiring only hours for recovery and having a high level of safety, along with a good potential for changing her health quotient for the better.

Pat arrived in Cancun, Mexico, to the treatment site of World Stem Cells, LLC contract clinics, doctors, and hospitals. The first day, she met with physicians to be evaluated, discuss her course of treatment and learn what to expect. She had been corresponding with Dr. Alan Kadish, the President of World Stem Cells, LLC. worldstemcells.com

Dr. Kadish is an unusual physician as he has training and practiced integrated primary care medicine combining conventional and naturopathic diagnostics and therapeutics for 27 years. He has been recognized as one of the leading quality physicians, in his field. Dr. Kadish is an American Board of Anti-Aging Medicine diplomat and completed numerous training programs in Achieving Clinical Excellence, or ACE, which provided opportunities to improve his practical skills in diagnosing and treating people based on their individual needs, using functional medical testing and treatment. He has been an advanced level practitioner (Autistic Research Institute) for autistic spectral disorder children and adults, since early 2000 and is certified in chelation therapy. As a naturopathic medical physician he lecturers frequently and is a host and guest on radio and internet outlets along with appearing in a number of print media publications. At World Stem Cells , LLC in addition to his management duties, he is a primary investigator engaged in research and designs of stem cell therapeutic protocols.

In Cancun, Pat met with specialists at Advanced Cellular Medicine Clinic. The clinic is headed by Dr. Sylvia Abblitt, who has the exclusive distinction of being among the few physicians who are licensed to perform autologous and allogeneic stem cell transplants in Mexico. Dr. Abblitt is a board-certified hematologist and oncologist. She has 11 years of expertise as a laboratory director and head of the hematology department at the Fernando Quiroz Hospital. She is a member of the American Association of Blood Banks and the International Cellular Medicine Society (ICMS). The Cancun clinic that Pat visited is a contract clinic of World Stem Cells, LLC. It houses the state-of-the-art Advanced Cellular Engineering Lab. The high-tech lab is suited for providing patients with the most up to date stem cell treatments and for conducting stem cell research to improve future opportunities for health.

After her evaluation and discussion of treatment options, Pat decided to go ahead with the stem cell therapy. The procedure involved a needle puncture to harvest her bone marrow utilizing her own stem cells. Only a local anesthesia was necessary and though she described the procedure as uncomfortable, she added that it was livable. The procedure took less than half an hour, and she experienced no side effects.

Pats improvement was remarkable and rapid. In fact, she did not feel fatigued and overwhelmed with pain, as she had in the past, when she traveled back home from Cancun by airplane and car. Within days, she had regained her ability to play piano. Playing at church concerts had always been a passion of hers, but she had been unable to play before her stem cell treatment because of a lack of coordination. She had much more energy after treatment, and was able to garden, run errands and work, without feeling exhausted. Her sleep was more restful. Her husband and friends noticed that her agility and balance were better. She could climb up and down stairs more easily and walk around the house without clutching the walls. Her speed on the treadmill was increasing gradually and she now walks a mile and a half on country roads.

Pat is extremely grateful to World Stem Cells, LLC for changing her life and giving her hope. For the first time, she has reversed many of the negative changes that she had been experiencing for years due to her CMT and lack of effective treatment. Now, Pat and her husband are experiencing a bright future and thankful that Pat was given this second opportunity, following stem cell therapy. worldstemcells.com.

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Pat was Diagnosed with “CMT” Disease and was Given a Second Chance with a Stem Cell Treatment