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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Doubt cast on clinical stem cell tests

Friday, Oct. 12, 2012

Harvard University said neither it nor Massachusetts General Hospital have ever authorized any iPS-related clinical studies by Hisashi Moriguchi, who claims to have achieved the first clinical application using the revolutionary stem cell technology.

"No clinical trials related to Moriguchi's work have been approved by institutional review boards at either Harvard University or Massachusetts General Hospital," a statement issued by Harvard and related institutes said Thursday.

The statement confirmed that Moriguchi "was a visiting fellow at Massachusetts General Hospital from 1999-2000," but added that he "has not been associated with (the institution) or Harvard since that time."

Moriguchi, a researcher at University of Tokyo Hospital, claimed to be a visiting lecturer at Harvard and to have conducted clinical trials at Massachusetts General Hospital with other researchers to transplant artificial cardiac muscle cells developed from iPS cells into six patients with heart disease.

The claim came just after Shinya Yamanaka of Kyoto University and a British scholar were jointly awarded this year's Nobel Prize in physiology or medicine for their research on iPS cells. Yamanaka and John Gurdon were credited with the discovery that mature human cells can be reprogrammed as immature cells capable of developing into all types of body parts.

"Research has been conducted after going through due procedures, such as consultations with a university ethics committee," Moriguchi claimed. "I have been told my method of creating iPS cells is different from the one used by Yamanaka (and Gurdon), but I have been doing it my way and no problems have been identified after transplants."

Moriguchi, who is thought to have asked a heart surgeon to carry out cell transplants, unveiled details about the treatment at a meeting of annual stem-cell research conference at Rockefeller University in New York held Wednesday and Thursday.

But the event's organizer, the nonprofit New York Stem Cell Foundation, subsequently said it "has received information from Harvard University that raises legitimate questions concerning a poster presentation" by Moriguchi, and has withdrawn it from the conference.

Moriguchi graduated from Tokyo Medical and Dental University with a degree in nursing science and does not have a license to practice medicine, according to a professor who taught him as an undergraduate.

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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

Stem Cell Transplants May Show Promise for Multiple Sclerosis

By Denise Mann WebMD Health News

Reviewed by Louise Chang, MD

Oct. 10, 2012 -- New research suggests that stem cell transplants to treat certain brain and nervous system diseases such as multiple sclerosis may be moving closer to reality.

One study found that experimental stem cell transplants are safe and possibly effective in children with a rare genetic brain disease. Another study in mice showed that these cells are capable of transforming into, and functioning as, the healthy cell type. The stem cells used in the two studies were developed by study sponsor StemCells, Inc.

Both papers appear online in Science Translational Research.

The work, while still in its infancy, may have far-reaching implications for the treatment of many more common diseases that affect the brain and nervous system.

Researchers out of the University of California, San Francisco (UCSF), looked at the how neural stem cells behaved when transplanted into the brains of four young children with an early-onset, fatal form of Pelizaeus-Merzbacher disease (PMD).

PMD is a very rare genetic disorder in which brain cells called oligodendrocytes can't make myelin. Myelin is a fatty substance that insulates the nerve fibers of the brain, spinal cord, and optic nerves (central nervous system), and is essential for transmission of nerve signals so that the nervous system can function properly.

In multiple sclerosis, the myelin surrounding the nerve is targeted and damaged by the body's immune system.

The new study found that the neural stem cell transplants were safe. What's more, brain scans showed that the implanted cells seem to be doing what is expected of them -- i.e. making myelin.

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Stem Cell Transplants May Show Promise for Multiple Sclerosis

RBCC: Nobel Prize Could Bring Big Investments in Stem Cell Research

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

The awarding of the Nobel Prize this week to two scientists who have revolutionized stem cell research could lead to an influx of investment capital into the industry, said Rainbow Coral Corp. (RBCC) CEO Patrick Brown on Wednesday.

Japans Shinya Yamanaka and Britain's John Gurdon were jointly awarded the medicine prize for proving that adult cells can be regressed back into stem cells, creating cells known as induced pluripotent stem cells (iPS) that allow for stem-cell research that doesnt necessitate the destruction of a fetus.

The tremendous recognition of this groundbreaking research that the Nobel Prize brings could spark a host of medical breakthroughs, investment interest and business developments in the stem cell field, Brown said. Its a very exciting time to be part of a young company striving to grow alongside this explosive industry.

Wire service AFP reported this week that Yamanaka will likely get up to 30 billion yen ($383 million) for his stem cell research over the next decade. RBCC is currently working to help speed up the research of Yamanaka and others into potential cures for deadly diseases by commercializing the use of a groundbreaking new technology in select markets around the world. The company has engaged Regenetech in discussions regarding the potential acquisition of a license to perform cell expansion using that companys Rotary Cell Culture SystemTM.

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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Early Results Show Promise for Stem Cells in Treating Chronic Liver Failure

Stem cell transfusions may someday replace the need for transplants in patients who suffer from liver failure caused by hepatitis B, according to a new study coming out of Beijing. . The results are published in the October issue of STEM CELLS Translational Medicine. Worldwide more than 500,000 people die each year from this condition.

Durham, NC (PRWEB) October 11, 2012

In China, hepatitis B virus (HBV) infection accounts for the highest proportion of liver failure cases. While liver transplantation is considered the standard treatment, it has several drawbacks including a limited number of donors, long waiting lists, high cost and multiple complications. Our study shows that mesenchymal stem cell (MSCs) transfusions might be a good, safe alternative, said Fu-Sheng Wang, Ph.D., M.D., the studys lead author and director of the Research Center for Biological Therapy (RCBT) in Beijing.

Wang along with RCBT colleague, Drs. Ming Shi and Zheng Zhang of the Research Center for Biological Therapy, The Institute of Translational Hepatology led the group of physician-scientists from the centers and Beijing 302 Hospital who conducted the study.

MSC transfusions had already been shown to improve liver function in patients with end-stage liver diseases. This time, the researchers wanted to gauge the safety and initial efficacy of treating acute-on-chronic liver failure (ACLF) with MSCs. The American Association for the Study of Liver Diseases and the European Association for the Study of the Liver define ACLF as an acute deterioration of pre-existing chronic liver disease usually related to a precipitating event and associated with increased mortality at three months due to multisystem organ failure. The short-term mortality rate for this condition is more than 50 percent.

MSCs have self-renewing abilities and the potential to differentiate into various types of cells. More importantly, they can interact with immune cells and cause the immune system to adjust to the desired level.

Of the 43 patients in this pilot study each of whom had liver failure resulting from chronic HBV infection 24 were treated with MSCs taken from donated umbilical cords and 19 were treated with saline as the control group. All received conventional therapy as well. The liver function, adverse events and survival rates were then evaluated during the 48-week or 72-week follow-up period.

Along with increased survival rates, the patients liver function improved and platelet count increased. No significant side effects were observed throughout the treatment and follow-up period.

While the results are preliminary and this pilot study includes a small number of patients, MSC transfusions appear to be safe and may serve as a novel therapeutic approach for HBV-associated ACLF patients, Dr. Shi said.

The study also highlights several key issues that will need to be considered in the design of future clinical studies, such as the optimal type of stem cells that will be infused, the minimum effective number of the cells and the best route of administration, Dr. Wang added.

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Early Results Show Promise for Stem Cells in Treating Chronic Liver Failure

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

ScienceDaily (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 October 11 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.

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The above story is reprinted from materials provided by University of Texas Health Science Center at Houston.

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

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

Brain Stem-Cell Implants Help Children With Rare Illness

Four boys with a rare and often fatal brain disease were implanted with stem cells that began fixing damage that impeded their ability to walk, talk and eat, a trial found.

The findings, published today in the journal Science Translational Medicine, are from the first stage of human tests funded by StemCells Inc. (STEM), a Newark, California-based company.

The children have a genetic disorder called Pelizaeus- Merzbacher, in which the brain cant make myelin, the fatty insulation for nerve cells that helps conduct brain signals. The children all had evidence of myelin growth a year later. The increased abilities shown by three of the boys in the University of California San Francisco study may bode well for other diseases caused by a lack of myelin insulation, including multiple sclerosis and cerebral palsy, the authors wrote.

Those were severely impaired children, said Stephen Back, a professor of pediatrics and neurology at Portlands Oregon Health & Science University, in a telephone interview. The fact that they showed any neurological improvement is very encouraging.

Back did work in mice that preceded todays work in humans, which he wasnt directly involved in. His study, published simultaneously, showed that the animals with no myelin at all grew some after being implanted with human stem cells.

Pelizaeus-Merzbacher disease causes the degeneration of the nervous system, and there is no cure or standard treatment. People with the illness experience a loss of coordination, thinking and motor abilities. Its one of several disorders linked to genes that control myelin production.

The incidence of the disease is 1 in 200,000 to 500,000 people, according to todays study of the boys.

The boys were between the ages of 1 and 6. They were given purified neural stem cells from a fetal brain, which was then grown in culture. The stem cells were inserted into the frontal lobe, using brain imaging as a guide. The boys brains were scanned 24 to 48 hours after surgery to assess safety.

The children were on drugs to suppress their immune systems and prevent their bodies from rejecting the stem cells for nine months. Side effects included rashes, diarrhea and fever. One boy had fluid collect under his scalp, which later vanished on its own. A second subject had some bleeding in the brain after the surgery, which was without clinical consequence, according to the paper.

One of the boys developed the ability to take steps with assistance and began to speak single words. Another started eating solid food on his own. A third began to walk without the assistance of a walker and began eating on his own.

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Brain Stem-Cell Implants Help Children With Rare Illness