Stem Cell Clinic

Patients seek stem-cell 'miracle,' but scientists warn of dangers

Boca Raton parents Gary and Judy Susser say they know the hope and promise of stem-cell therapy. Nine years ago they traveled to Mexico for stem cell injections for their son Adam, who has cerebral palsy.

"Maybe it will do some good," Gary Susser said he and his wife thought at the time. They spent $25,000.

But the Sussers stopped stem cell injections in 2005, after spending about $25,000 and seeing no improvement. Now armed with more information, the Sussers are grateful the treatments didn't harm Adam, now 12. While they are advocates of "responsible" stem cell research, they warn other parents against making trips to Costa Rica, Mexico, Russia or other offshore clinics for experimental treatments.

With promising breakthroughs making the news, as well as Internet hype, desperate parents and seriously ill patients may look to stem-cell therapy as the modern miracle that could cure them. And one day, stem cells may be routinely used to repair damaged cells, improve the treatment of diseases and even cure paralysis.

But there are hidden dangers to today's stem cell treatments, both in the U.S. and offshore, scientists said at the recent World Stem Cell Summit in West Palm Beach. They pointed to reports of deaths, tumors, lumbar punctures and other potential harm, as well as vulnerable people being conned out of thousands of dollars.

Patients are "buying hope," said University of Miami scientist James Guest, working on The Miami Project to Cure Paralysis. But he and other scientists say that responsible research takes years to complete. The Miami Project, in the making for 25 years, is just now reaching the human clinical trial stage, he says.

Scientists urge consumers look for regulated clinical trials at universities and research institutions, saying that even those are not without risks.

"Clinics are operating out of loopholes, a gray area disguised as the practice of medicine," said George Q. Daley, director of the stem cell transplantation program at HHMI/Children's Hospital in Boston.

Industry researcher Douglas Sipp has kept records of more than 400 companies advertising stem cell products or procedures on websites since 2007. When he rechecked this summer, Sipp said 80 of the sites were no longer online, though they could have simply changed web addresses.

Some of the offshore clinics have been closed by individual countries after patients died, according to Sipp, who leads the research unit for Science Policy and Ethics Studies at the RIKEN Center in Japan.

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Patients seek stem-cell 'miracle,' but scientists warn of dangers

Perry brings Texas stem-cell cause to Houston

Gov. Rick Perry pushed Friday for Texas to become the center of adult stem-cell therapy, disregarding the federal government's increasing crackdown on clinics marketing the experimental medicine.

Perry told a crowd of stem-cell researchers, industry leaders and patients gathered in Houston that the young science "holds the promise of miracles" desperately needed by people across the world and suggested Texas' "wildcat spirit" and "conducive climate" can make it happen here.

"I'm not shy about asking people to relocate or start up their companies in Texas," said Perry, likening stem-cell treatment to previous innovations in space and heart care. "All of you outside the state of Texas - come on in. The water's fine. We've got an amazing environment here."

Perry, who famously got the unlicensed treatment for an ailing back in 2011, said the state has made sure that innovators won't be "hindered by exorbitant taxes, wrapped up by bureaucratic red tape or at the mercy of predatory attorneys, seeking to make steady money off extensive, drawn-out court cases."

Perry's remarks, made at the first of a planned annual Houston conference, came as the state appears headed toward a collision with the Food and Drug Administration, which has begun stepping up action against businesses that treat patients with their own stem cells. Last month, it issued a warning letter to Celltex Therapeutics Corp., the largest facilitator of the therapy in the Houston area, saying the process it puts the cells through alters them and makes them a biologic drug. The letter said the therapy was thus under FDA jurisdiction.

Perry's position

The letter was delivered just a few months after the Texas Medical Board began implementing a policy allowing doctors to use stem cells banked at facilities such as Celltex as long as it's part of research overseen by a panel that reviews clinical trials for patient safety. The TMB said it was allowing stem-cell use because it couldn't wait on the FDA.

As a result of the FDA letter, Celltex is in the process of closing down its 2012 trials.

Perry told the media after his keynote address that he disagrees with the FDA's decision on Celltex. He said that therapy involving one's own stem cells should no more be regulated by the FDA than bone marrow transplants or in-vitro fertilization.

Stem cells are cells in the body that multiply to replenish dying cells. The basis of what's known as regenerative medicine because of their ability to grow new tissue and repair diseased or injured body parts, they are touted by some as the future of medicine.

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Perry brings Texas stem-cell cause to Houston

Gene variation may shape bladder cancer treatment, study suggests

Jan. 3, 2013 Patients who have inherited a specific common genetic variant develop bladder cancer tumors that strongly express a protein known as prostate stem cell antigen (PSCA), which is also expressed in many pancreatic and prostate tumors, according to research at the National Institutes of Health.

A therapy targeting the PSCA protein on the tumor cell surface is under evaluation in clinical trials for prostate and pancreatic cancer. The researchers hope that this therapy will be tested in bladder cancer patients with the genetic variant, which could help to reduce potentially harmful side-effects, lower costs, and improve treatment efficacy.

Every gene contains a very long string of DNA components termed nucleotides (referenced commonly as T, C, G or A). A single letter variation in the string of letters can lead to changes in cell development, resulting in cancer.

In a previous study, the researchers identified a variant located in the PSCA gene on chromosome 8 as associated with bladder cancer susceptibility. The gene determines whether the corresponding protein is expressed in bladder tumor tissue. In the latest report, they found that the 'T' nucleotide that comprises a gene variant called rs2294008 is a strong predictor of PSCA protein expression. The variant results in increased delivery of the protein to the cell surface, where it is involved in signaling and promotes tumor growth. The study by scientists from the National Cancer Institute (NCI), part of the National Institutes of Health, appeared online in the Journal of the National Cancer Institute on Dec. 23, 2012.

"We've been pursuing this mechanism for some time now. It started with our early results from the initial genome-wide association study that revealed a marker in the PSCA gene related to bladder cancer risk. This latest work reveals how a specific letter change in DNA influences protein expression at the cell surface. The big payoff is that a simple genetic test can determine which patients could benefit from anti-PSCA therapy," said Ludmila Prokunina-Olsson, Ph.D., NCI Division of Cancer Epidemiology and Genetics, and senior author of this publication.

In 2012 in the United States alone, there were an estimated 73,510 new cases of bladder cancer and 14,880 deaths. The recurrence rate of bladder cancer is between 50 and 70 percent, and patients require life-long surveillance and treatment, making it an expensive cancer to live with and a major economic burden on the health care system and patients. Up to 75 percent of bladder cancer patients carry this genetic variant.

"This is one of the first studies to show direct clinical implications of a genetic variant identified through genome-wide association studies for common cancers," said Stephen J. Chanock, M.D., acting co-director for the NCI Center for Cancer Genomics.

The scientists note that additional work is needed to develop alternative drugs targeting PSCA, and to evaluate drug delivery methods, such as systemic delivery for advanced muscle-invasive tumors and local, inter-bladder delivery in the case of non-muscle invasive tumors. Anti-PSCA therapy is likely to be effective only against tumors that express PSCA. A genetic test for the "T" nucleotide of this genetic variant can identify bladder cancer patients who could benefit from this treatment.

This research was supported by intramural funding at the NCI under contract number ZIA CP010201-04.

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Gene variation may shape bladder cancer treatment, study suggests

How you can use Facebook to help this leukemia patient find his missing donor

A sign outside of Facebook headquarters (Atlantic Wire)It was literally a one in ten million chance when Paul Zamecnik was matched up with a stem cell donor who could finally help the 53-year-old Virginia man get a sustainable treatment for his leukemia.

But after the potential donor failed to show up for his scheduled appointment, Zamecnik has been forced to turn to Facebook in a desperate attempt to find the man who could literally save his life.

"Basically I'm a really good candidate for a transplant. The only thing I'm missing is a donor," Zamecnik told a Virginia NBC affiliate.

"I have no way of knowing who it is and where he lives," Zamecnik said. "The donor programs keep all that at an arm's length. But I sure would love to get him to change his mind.

To that end, Zamecnik has started a Facebook page, which he hopes will eventually put him in touch with the anonymous donor about which Zamecnik knows very little only that he is a 25-year-old man living in the U.S.

"After all, we are only 6 degrees of separation from everyone in the world, right? Zamecnik writes on the page. And what better gift is there during this holiday season than giving someone a second chance at life? Would you please help me out by reposting this?"

Though we here at the Sideshow specialize in bringing you the days odd news, we also like to share the occasional opportunity for Yahoo! readers to reach out and help others from time to time.

And even if you cant help him track down his potentially life saving donor, Zamecnik encourages people to become donors themselves, by visiting the BeTheMatch.com site.

The Facebook page has already received more than 45,000 likes since first going live on Friday morning. Hundreds of readers have posted comments of support and have pledged their effort to help Zamecnik find his potential donor.

Diagnosed at age 45, Zamecnik has received three different types of chemotherapy treatment over the past eight years, but says the treatments are becoming less effective and are expected to eventually not help at all.

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How you can use Facebook to help this leukemia patient find his missing donor

Stem Cell Showdown: Celltex vs. the FDA

Cecelia Johnson was an artist, cellist, tap dancer, and 22-year-old college student when she was diagnosed with multiple sclerosis in 2001. The disease, in which the bodys immune system attacks the tissue protecting nerves, proceeds at its own pace: Sometimes the deterioration is halting, sometimes it can be delayed, but there is no cure. Johnsons decline was swift.

Six years after her diagnosis, undone by fatigue and pain and often unable to walk, Johnson gave up on conventional medicine. In the spring of 2007 she traveled from her home in Houston to Mexico, where an American doctor gave her an infusion of adult stem cells that were supposed to regenerate her damaged tissue. I thought this guy might be peddling snake oil, says Johnson. But I would have taken snake oil. The procedure cost her $14,000.

Within a few months, she began to feel better. The effects werent lasting, though, and she returned to Mexico every year until the Federal Bureau of Investigation arrested her doctor in December2011. Francisco Morales was accused of conspiracy and fraud: He wasnt a licensed doctor, and he was using umbilical-cord stem cells he bought in the U.S. for treatments that the Food and Drug Administration had not approved. He pleaded guilty in September 2012 and awaits sentencing.

By then, Johnson had learned she could receive infusions of her own stem cells in Houston. An orthopedic surgeon there, Stanley Jones, had recently co-founded Celltex Therapeutics, a company that multiplied and stored adult stem cells. It took Johnson and her mother much of the spring and summer of 2012 to raise the $30,000 fee for the treatment, which was part of a clinical study. A study I have to pay $30,000 for? Sure, Im skeptical, says Johnson. The point is that stem cells are available, I desperately need them, and I will pay for them. In August, Johnson had several hundred thousand stem cells harvested from her abdominal fat.

Photograph by Thomas Prior for Bloomberg BusinessweekEller and Jones founded Celltex in 2011

Jones was not just a doctor, he was also a satisfied customer. He had been treated for autoimmune arthritis with his own adult stem cells through a South Korean company, RNLBio. In March2011, he and Houston businessman David Eller founded Celltex, one of the first commercial stem cell laboratories in the country. They had RNLs technology and eventually some 200 paying patients desperate for relief. One of them was Texas Governor Rick Perry, who suffered from back problems. Together they encouraged the state medical authority to let doctors provide stem cell treatments under its supervision.

Then the FDA got involved: The agency inspected Celltexs lab, found 14 major manufacturing problems, and later warned the company it was illegally marketing an unlicensed drug. Celltex shut down the lab in early October 2012, four days before Johnson was to receive her first batch of cells. It hasnt yet resumed processing stem cells for Johnson or anyone else. In a December letter to patients the company stated: Celltex remains fully committed to advance the most promising new field in human health in decadesregenerative medicine.

Celltexs venture raises some of the most vexing, emotional issues in the business of medicine. Stem cells hold enormous promise, but promise isnt proof, and anecdotal evidence isnt science. Small companies often cant do the research required by the FDA and make money at the same time. Some patients will pay to be part of an experiment, but many doctors and regulators dont think they should. In Texas the science of stem cells has collided with a governors ambitions, a businessmans optimism, a doctors faith, and patients hopes. It seemed too good to be true, Johnson says, and it was. Stem cells, often thought of as the bodys master cells, help form and repair tissue, organs, and blood. There are different types of stem cells, each with their own capabilities. Embryonic stem cells, potentially the most powerful, are the most controversial; George W. Bush restricted federal funding for embryonic stem cell research when he was in office. Induced pluripotent stem cells are adult cells that have been genetically reprogrammed to have some attributes of embryonic stem cells. Adult stem cells are believed to exist in tissue throughout the body. The main function of mesenchymal adult stem cells, the type Celltex works with, is to repair tissue damaged by daily use. They also have anti-inflammatory properties. The cells can be found in special niches in bone marrow, umbilical-cord blood, muscle, and fat. When the body is injured, the cells leave their niche and become more specialized, but they are not, like embryonic stem cells, able to transform into any kind of cell. A blood-forming cell can become a red blood cell; it cant become a brain cell.

Dr. Gary D. Gaugler/PhototakeA blood-forming adult stem cell, found in bone marrow

Hundreds of clinical studies are under way in the U.S. to test the safety and efficacy of stem cells for all sorts of disorders: Alzheimers, Crohns, Epstein-Barr, lymphoma, diabetes, multiple sclerosis, infertility. Scientists say stem cells could help repair the heart or spine, regenerate cartilage, and improve brain function after a stroke. Were formed from stem cells, everything about our body is a stem cell product, says James Willerson, president of the Texas Heart Institute, where about half of the research conducted involves stem cells. I believe the right cells in the right place in the right person will do amazing things. Arnold Caplan, a professor of biology at Case Western Reserve University and founder of two stem cell companies, says: It sounds like stem cells could be the magic elixir for every malady. The answer is that, on a scientific basis, they could be.

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Stem Cell Showdown: Celltex vs. the FDA

Stem cell technology could help harness patients' own immune cells to fight disease

Jan. 3, 2013 The human body contains immune cells programmed to fight cancer and viral infections, but they often have short lifespans and are not numerous enough to overcome attacks by particularly aggressive malignancies or invasions. Now researchers reporting in two separate papers in the January 4th issue of the Cell Press journal Cell Stem Cell used stem cell technology to successfully regenerate patients' immune cells, creating large numbers that were long-lived and could recognize their specified targets: HIV-infected cells in one case and cancer cells in the other.

The findings could help in the development of strategies to rejuvenate patients' exhausted immune responses.

The techniques the groups employed involved using known factors to revert mature immune T cells into induced pluripotent stem cells (iPSCs), which can differentiate into virtually any of the body's different cell types. The researchers then expanded these iPSCs and later coaxed them to redifferentiate back into T cells. Importantly, the newly made T cells were "rejuvenated" with increased growth potential and lifespan, while retaining their original ability to target cancer and HIV-infected cells. These findings suggest that manipulating T cells using iPSC techniques could be useful for future development of more effective immune therapies.

In one study, investigators used T cells from an HIV-infected patient. The redifferentiated cells they generated had an unlimited lifespan and contained long telomeres, or caps, on the ends of their chromosomes, which protect cells from aging. This is significant because normal aging of T cells limits their expansion, making them inefficient as therapies. "The system we established provides 'young and active' T cells for adoptive immunotherapy against viral infection or cancers," says senior author Dr. Hiromitsu Nakauchi, of the University of Tokyo.

The other research team focused on T cells from a patient with malignant melanoma. The redifferentiated cells they created recognized the protein MART-1, which is commonly expressed on melanoma tumors. "The next step we are going to do is examine whether these regenerated T cells can selectively kill tumor cells but not other healthy tissues. If such cells are developed, these cells might be directly applied to patients," says senior author Dr. Hiroshi Kawamoto, of the RIKEN Research Center for Allergy and Immunology. "This could be realized in the not-so-distant future."

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The above story is reprinted from materials provided by Cell Press, via EurekAlert!, a service of AAAS.

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Stem cell technology could help harness patients' own immune cells to fight disease

EastBridge Investment Group announces Cellular BioMedicine Group a keynote speaker at New York Stem Cell Summit

PHOENIX, Jan. 2, 2013 /PRNewswire/ -- EastBridge Investment Group Corporation (EBIG), a provider of financial consulting services to companies in Asia ("EBIG") today announced Cellular BioMedicine Group ("CBMG") has been invited to give a keynote speech at the 8th Annual New York Stem Cell Summit, February 19, 2013. Dr. William Cao, president of CBMG , will deliver the keynote speech for CBMG.

EastBridge plans to merge with CBMG in January, 2013.

About Cellular Biomedicine GroupCellular Biomedicine Group, Ltd. is in the development of cell therapies for the treatment of certain cancer and degenerative diseases. Our developmental stem cell, progenitor cell, and immune cell projects are the result of collaborative research and development between scientists and doctors from the U.S. and China. Its flagship GMP facility, consisting of eight independent cell production lines, is designed, certified and managed according to U.S. standards. To learn more about CBMG, please visit: http://www.cellbiomedgroup.com

About EastBridgeEastBridge Investment Group focuses on high-growth companies in Asia and in the United States, offering assistance with all aspects of IPOs, joint ventures and merchant banking services. EastBridge targets industries in the fields of electronics, real estate, auto, metal, energy, environmental, bioscience and retail food distribution. To learn more about EastBridge Investment Group go to our web site: http://www.EbigCorp.com. To receive EBIG's email alert, send a blank email to info@EbigCorp.com.

Forward-Looking StatementsStatements in this press release relating to plans, strategies, economic performance and trends, projections of results of specific activities or investments, and other statements that are not descriptions of historical facts may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include, but are not limited to, risk factors inherent in doing business. Forward-looking statements may be identified by terms such as "may," "will," "expects," "plans," "intends," "estimates," "potential," or "continue," or similar terms or the negative of these terms. Although EastBridge and CBMG believe the expectations reflected in the forward-looking statements are reasonable, they cannot guarantee that the announced merger will in fact be consummated or that future results, levels of activity, performance or achievements will be obtained. Neither EastBridge nor CBMG has any obligation to update these forward-looking statements other than as required by law.

Contact: Jeff Ramson Investor Relations ProActive Capital Group 646-863-6341

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EastBridge Investment Group announces Cellular BioMedicine Group a keynote speaker at New York Stem Cell Summit

NIH Study Suggests Gene Variation May Shape Bladder Cancer Treatment

Newswise Patients who have inherited a specific common genetic variant develop bladder cancer tumors that strongly express a protein known as prostate stem cell antigen (PSCA), which is also expressed in many pancreatic and prostate tumors, according to research at the National Institutes of Health.

A therapy targeting the PSCA protein on the tumor cell surface is under evaluation in clinical trials for prostate and pancreatic cancer. The researchers hope that this therapy will be tested in bladder cancer patients with the genetic variant, which could help to reduce potentially harmful side-effects, lower costs, and improve treatment efficacy.

Every gene contains a very long string of DNA components termed nucleotides (referenced commonly as T, C, G or A). A single letter variation in the string of letters can lead to changes in cell development, resulting in cancer.

In a previous study, the researchers identified a variant located in the PSCA gene on chromosome 8 as associated with bladder cancer susceptibility. The gene determines whether the corresponding protein is expressed in bladder tumor tissue. In the latest report, they found that the T nucleotide that comprises a gene variant called rs2294008 is a strong predictor of PSCA protein expression. The variant results in increased delivery of the protein to the cell surface, where it is involved in signaling and promotes tumor growth. The study by scientists from the National Cancer Institute (NCI), part of the National Institutes of Health, appeared online in the Journal of the National Cancer Institute on Dec. 23, 2012.

Weve been pursuing this mechanism for some time now. It started with our early results from the initial genome-wide association study that revealed a marker in the PSCA gene related to bladder cancer risk. This latest work reveals how a specific letter change in DNA influences protein expression at the cell surface. The big payoff is that a simple genetic test can determine which patients could benefit from anti-PSCA therapy, said Ludmila Prokunina-Olsson, Ph.D., NCI Division of Cancer Epidemiology and Genetics, and senior author of this publication.

In 2012 in the United States alone, there were an estimated 73,510 new cases of bladder cancer and 14,880 deaths. The recurrence rate of bladder cancer is between 50 and 70 percent, and patients require life-long surveillance and treatment, making it an expensive cancer to live with and a major economic burden on the health care system and patients. Up to 75 percent of bladder cancer patients carry this genetic variant.

This is one of the first studies to show direct clinical implications of a genetic variant identified through genome-wide association studies for common cancers, said Stephen J. Chanock, M.D., acting co-director for the NCI Center for Cancer Genomics.

The scientists note that additional work is needed to develop alternative drugs targeting PSCA, and to evaluate drug delivery methods, such as systemic delivery for advanced muscle-invasive tumors and local, inter-bladder delivery in the case of non-muscle invasive tumors. Anti-PSCA therapy is likely to be effective only against tumors that express PSCA. A genetic test for the T nucleotide of this genetic variant can identify bladder cancer patients who could benefit from this treatment.

This research was supported by intramural funding at the NCI under contract number ZIA CP010201-04.

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NIH Study Suggests Gene Variation May Shape Bladder Cancer Treatment

Desperate patients seek stem-cell 'miracle,' but scientists warn of hidden dangers

Boca Raton parents Gary and Judy Susser say the know the hope and promise of stem-cell therapy. Nine years ago they traveled to Mexico for stem cell injections for their son Adam, who has cerebral palsy.

"Maybe it will do some good," Gary Susser said he and his wife thought at the time. They spent $25,000.

But the Sussers stopped stem cell injections in 2005, after spending about $25,000 and seeing no improvement. Now armed with more information, the Sussers are grateful the treatments didn't harm Adam, now 12. While they are advocates of "responsible" stem cell research, they warn other parents against making trips to Costa Rica, Mexico, Russia or other offshore clinics for experimental treatments.

With promising breakthroughs making the news, as well as Internet hype, desperate parents and seriously ill patients may look to stem-cell therapy as the modern miracle that could cure them. And one day, stem cells may be routinely used to repair damaged cells, improve the treatment of diseases and even cure paralysis.

But there are hidden dangers to today's stem cell treatments, both in the U.S. and offshore, scientists said at the recent World Stem Cell Summit in West Palm Beach. They pointed to reports of deaths, tumors, lumbar punctures and other potential harm, as well as vulnerable people being conned out of thousands of dollars.

Patients are "buying hope," said University of Miami scientist James Guest, working on The Miami Project to Cure Paralysis. But he and other scientists say that responsible research takes years to complete. The Miami Project, in the making for 25 years, is just now reaching the human clinical trial stage, he says.

Scientists urge consumers look for regulated clinical trials at universities and research institutions, saying that even those are not without risks.

"Clinics are operating out of loopholes, a gray area disguised as the practice of medicine," said George Q. Daley, director of the stem cell transplantation program at HHMI/Children's Hospital in Boston.

Industry researcher Douglas Sipp has kept records of more than 400 companies advertising stem cell products or procedures on websites since 2007. When he rechecked this summer, Sipp said 80 of the sites were no longer online, though they could have simply changed web addresses.

Some of the offshore clinics have been closed by individual countries after patients died, according to Sipp, who leads the research unit for Science Policy and Ethics Studies at the RIKEN Center in Japan.

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Desperate patients seek stem-cell 'miracle,' but scientists warn of hidden dangers