First case of alleged stem-cell fraud enters US courts

The days of "stem-cell tourism" could be numbered. Six residents of Los Angeles, California, are suing South Korean company RNL Bio and associates in a Californian court for alleged fraud. They claim the company convinced them to travel to clinics in South Korea, China or Mexico to donate fat tissue and have stem cells from it re-administered to cure diseases and even reverse ageing.

Stem cells hold great medical promise, but only one treatment is licensed in the US and that is for a rare blood disorder. Others are experimental and it is illegal to offer them commercially. Yet some companies still tout stem-cell "cures" that are carried out outside the US. RNL Bio calls its fat-tissue stem cells "safe technologies" for treating various disorders.

There have been protests against these treatments for years, but this is the first civil lawsuit for damages, says Paul Knoepfler of the University of California at Davis. It "serves notice to the purveyors of unproven stem-cell treatments" that they may face litigation if they market in the US, says Bernard Siegel of the Genetics Policy Institute, a stem-cell watchdog in Palm Beach, Florida.

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First case of alleged stem-cell fraud enters US courts

Arthritis stem cell jab 'could ease pain for millions'

Stem cells taken from stomach fat and used to regenerate knee tissue Charity chief says therapy potentially 'transformational'

By Claire Bates

PUBLISHED: 05:15 EST, 10 July 2012 | UPDATED: 08:23 EST, 10 July 2012

An injection of stem cells taken from body fat could one day help patients recover from crippling osteoarthritis.

The treatment, which has been successfully trialled on animals, helps the body regrow tissue and cartilage that has been damaged by the degenerative condition.

Although still at an experimental stage, experts say the therapy could be 'transformational' for the six million people in the UK who suffer from the condition.

Osteoarthritis occurs when there is damage in and around a joint which the body cannot repair

Early results suggest the treatment, from Australian company Regeneus, could delay the need for joint repair by 10 or 20 years. There is the possibility that it could stop the disease's progression altogether if caught early.

Judith Brodie, chief executive of Arthritis Care, told Mail Online: 'This new stem cell therapy, if the trials continue to show success, could be transformational.

'While the long-term effects are unknown, and there should be caution due to the early stage of development, Arthritis Care welcomes progress in treating this painful condition.'

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Arthritis stem cell jab 'could ease pain for millions'

Fort Myers doctor reaching settlement with state in stem cell patient's death

K.K.Yankopolus

Photo by Allie Garza

Dr. Zannos Grekos, a cardiologist whose practice is in Bonita Springs, speaks with a seminar attendant after one of his educational seminars about stem cell treatment, using one's own stem cells, for treating heart disease and other medical conditions, on Monday, March 14, 2011, at the Collier County Library. Allie Garza/Staff

FORT MYERS A Fort Myers physician whose license was restricted for his involvement in a controversial stem cell treatment on a patient who died has a settlement in the works with state regulators.

Terms of the deal between Dr. Konstantine Yankopolus and the Florida Department of Health weren't immediately available Monday.

"It's in draft form," said Yankopolus' attorney, Steven Ramunni, of Fort Myers.

Yankopolus said Monday he expects the restriction on his license to be lifted soon.

"I want to stay in the world of service," he said. "Let's move on."

An obstetrician for years before switching to a general practice, Yankopolus assisted Dr. Zannos Grekos, a Bonita Springs cardiologist, on March 2 in a stem cell procedure on a 77-year-old Indiana man. The patient, Richard Poling, came to Grekos for stem cell treatment against his pulmonary hypertension.

Grekos accepted the patient even though he was under a 2011 state order not to do anything with stem cells or bone marrow aspirate in his Bonita Springs practice. The order came after the death of a breast cancer patient treated by Grekos, who had developed a following for sending patients to the Dominican Republic for stem cell procedures for their chronic medical conditions.

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Fort Myers doctor reaching settlement with state in stem cell patient's death

Capricor Announces FDA Approval To Initiate ALLSTAR Trial of Allogeneic Stem Cell Therapy In Patients Following Heart …

LOS ANGELES--(BUSINESS WIRE)--

Capricor, Inc., a privately held biotechnology company focused on regenerative medicine, today announced that the U.S. Food and Drug Administration has approved initiation of its Investigational New Drug (IND) application for the ALLSTAR study, which will use allogeneic cardiac-derived stem cells (CDCs) to treat patients following large myocardial infarctions (MI).

ALLSTAR will study the use of CAP-1002 delivered directly into a coronary artery from thirty days to one year following a heart attack. The trial will have a 14 patient lead in phase and is planned as a 260 patient, twenty center randomized controlled trial. ALLSTAR will study a variety of safety and effectiveness endpoints with the goal of demonstrating sufficiently strong data to permit an eventual Phase III trial as a path to commercialization of CAP-1002.

ALLSTAR is predicated on the positive results of the landmark CADUCEUS trial that showed approximately 50 percent reduction of scar size and 50 percent more viable muscle in the infarction zones of patients studied one year after a heart attack. ALLSTAR will use donor cells whereas CADUCEUS used each patients own CDCs. The shift from autologous to allogeneic cells is supported by extensive pre-clinical evidence of safety and effectiveness and is expected to expand the market opportunity as well as to reduce the costs for treatment.

"IND approval for ALLSTAR is another major milestone for Capricor as we continue to develop cardiac-derived stem cells for the treatment of heart disease," said Linda Marbn, Ph.D., CEO of Capricor. "There are greater than 6 million people in the US living with heart failure, and that number continues to rise as heart disease remains the number one killer. Capricors CDCs represent a novel treatment to repair the heart after muscle loss following large heart attacks through the regeneration of heart muscle and the shrinking of scar tissue. Our ultimate goal will be to demonstrate that muscle regeneration in these patients will result in clinically meaningful improvements to their lives."

"This is terrific news, says Ellen Feigal, M.D., Senior Vice President for Research and Development at Californias stem cell agency, CIRM. This is the first time a Disease Team funded by CIRM has been given an Investigational New Drug (IND) approval from the FDA, a critical step in testing promising therapies in patients. Its a reflection of the progress being made in turning promising therapies into real-world treatments.

Capricor has asked CIRM to assist in the funding of a portion of ALLSTAR. Capricor was founded Baltimore and moved to California almost five years ago in part because of the environment that CIRM has created to foster stem cell research in this state. We are grateful to have received the seed support from CIRM that has funded a portion of our research. Our mission is to develop meaningful treatments for patients suffering from heart disease and to grow Capricor into a major California biotechnology company, said Linda Marbn.

About CAP-1002

CAP-1002, Capricor's lead candidate, is a proprietary allogeneic adult stem cell product for the treatment of myocardial infarction. The product contains multiple progenitor cells and is derived from donor heart tissue. The cells are multiplied in the laboratory using a specialized process, and then introduced directly into a patients heart via infusion in a coronary artery at the time of standard cardiac catherization.

About Capricor, Inc.

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Capricor Announces FDA Approval To Initiate ALLSTAR Trial of Allogeneic Stem Cell Therapy In Patients Following Heart ...

UCLA researcher discovers epigenetic links in cell-fate decisions of adult stem cells

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

Contact: Brianna Deane bdeane@dentistry.ucla.edu 310-206-0835 University of California - Los Angeles

The ability to control whether certain stem cells ultimately become bone cells holds great promise for regenerative medicine and potential therapies aimed at treating metabolic bone diseases.

Now, UCLA School of Dentistry professor and leading cancer scientist Dr. Cun-Yu Wang and his research team have made a significant breakthrough in that direction. The scientists have discovered two key epigenetic regulating genes that govern the cell-fate determination of human bone marrow stem cells.

Wang's new research is featured on the cover of the July 6 issue of Cell Stem Cell, the affiliated journal of the International Society for Stem Cell Research.

The groundbreaking study grew out of Wang's desire to better understand the epigenetic regulation of stem cell differentiation, in which the structure of genes is modified while the sequence of the DNA is not. He and his team found that KDM4B and KDM6B, two gene-activating enzymes, can promote stem cells' differentiation into bone cells by removing methyl markers from histone proteins. This process occurs through the activation of certain genes favoring a commitment to one lineage and the concurrent deactivation of genes favoring other lineages.

The findings imply that chemical manipulation of these gene-activating enzymes may allow stem cells to differentiate specifically into bone cells, while inhibiting their differentiation into fat cells. The group's research could pave the way toward identifying potential therapeutic targets for stem cellmediated regenerative medicine, as well as the treatment of bone disorders like osteoporosis, the most common type of metabolic bone disease.

"Through our recent discoveries on the lineage decisions of human bone marrow stem cells, we may be more effective in utilizing these stem cells for regenerative medicine for bone diseases such as osteoporosis, as well as for bone reconstruction," Wang said. "However, while we know certain genes must be turned on in order for the cells to become bone-forming cells, as opposed to fat cells, we have only a few clues as to how those genes are switched on."

The research group, through its study of aging mice, found that the two enzymes KDM4B and KDM6B could specifically activate genes that promote stem cell differentiation toward bone, while blocking the route toward fat.

"Interestingly, in our aged mice, as well as osteoporotic mice, we observed a higher amount of silencing histone methyl groups which were normally removed by the enzymes KDM4B and KDM6B in young and healthier mice," Wang said. "And since these enzymes can be easily modified chemically, they may become potential therapeutic targets in tissue regeneration and treatment for osteoporosis."

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UCLA researcher discovers epigenetic links in cell-fate decisions of adult stem cells

Discovery of epigenetic links in cell-fate decisions of adult stem cells paves way for new osteoporosis treatments

ScienceDaily (July 9, 2012) The ability to control whether certain stem cells ultimately become bone cells holds great promise for regenerative medicine and potential therapies aimed at treating metabolic bone diseases.

Now, UCLA School of Dentistry professor and leading cancer scientist Dr. Cun-Yu Wang and his research team have made a significant breakthrough in that direction. The scientists have discovered two key epigenetic regulating genes that govern the cell-fate determination of human bone marrow stem cells.

Wang's new research is featured on the cover of the July 6 issue of Cell Stem Cell, the affiliated journal of the International Society for Stem Cell Research.

The groundbreaking study grew out of Wang's desire to better understand the epigenetic regulation of stem cell differentiation, in which the structure of genes is modified while the sequence of the DNA is not. He and his team found that KDM4B and KDM6B, two gene-activating enzymes, can promote stem cells' differentiation into bone cells by removing methyl markers from histone proteins. This process occurs through the activation of certain genes favoring a commitment to one lineage and the concurrent deactivation of genes favoring other lineages.

The findings imply that chemical manipulation of these gene-activating enzymes may allow stem cells to differentiate specifically into bone cells, while inhibiting their differentiation into fat cells. The group's research could pave the way toward identifying potential therapeutic targets for stem cell-mediated regenerative medicine, as well as the treatment of bone disorders like osteoporosis, the most common type of metabolic bone disease.

"Through our recent discoveries on the lineage decisions of human bone marrow stem cells, we may be more effective in utilizing these stem cells for regenerative medicine for bone diseases such as osteoporosis, as well as for bone reconstruction," Wang said. "However, while we know certain genes must be turned on in order for the cells to become bone-forming cells, as opposed to fat cells, we have only a few clues as to how those genes are switched on."

The research group, through its study of aging mice, found that the two enzymes KDM4B and KDM6B could specifically activate genes that promote stem cell differentiation toward bone, while blocking the route toward fat.

"Interestingly, in our aged mice, as well as osteoporotic mice, we observed a higher amount of silencing histone methyl groups which were normally removed by the enzymes KDM4B and KDM6B in young and healthier mice," Wang said. "And since these enzymes can be easily modified chemically, they may become potential therapeutic targets in tissue regeneration and treatment for osteoporosis."

"The discovery that Dr. Wang and his team have made has considerable implications for craniofacial bone regeneration and treatment for osteoporosis," said Dr. No-Hee Park, dean of the UCLA School of Dentistry. "As a large portion of our population reaches an age where osteoporosis and gum disease could be major health problems, advancements in aging-related treatment are very valuable."

Professor Wang holds the No-Hee Park Endowed Chair in Dentistry at the UCLA School of Dentistry, where he is also chair of the division of oral biology and medicine and the associate dean for graduate studies.

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Discovery of epigenetic links in cell-fate decisions of adult stem cells paves way for new osteoporosis treatments

Antibodies from rabbits improve survival of leukemia and myelodysplasia patients receiving stem cell transplant

ScienceDaily (July 6, 2012) Researchers at Virginia Commonwealth University (VCU) Massey Cancer Center's Bone Marrow Transplant Program have demonstrated that the use of antibodies derived from rabbits can improve the survival and relapse outcomes of leukemia and myelodysplasia patients receiving a stem cell transplant from an unrelated donor.

Recently published in the journal Bone Marrow Transplantation, a study led by Amir Toor, M.D., hematologist-oncologist in the Bone Marrow Transplant Program and member of the Developmental Therapeutics program at VCU Massey Cancer Center, retrospectively compared the outcomes of 50 patients who received rabbit anti-thymocyte globulin (ATG) before receiving a transplant of stem cells from an unrelated donor to the outcomes of 48 patients who received a transplant of stem cells from a related donor. While unrelated stem cell transplants typically have poorer outcomes than related stem cell transplants, the results from this study showed similar outcomes for each group in terms of mortality, relapse and the development of graft-versus-host disease (GVHD), a common complication that can occur after a stem cell or bone marrow transplant in which the newly transplanted material attacks the transplant recipient's body.

"Unfortunately, we can't always find a related (genetically similar) donor for patients in need of stem cell transplantation," says Toor, who is also associate professor of internal medicine in the Department of Hematology, Oncology and Palliative Care at VCU School of Medicine. "Obtaining better outcomes with unrelated donor stem cell transplants could represent a significant advancement in extending the lives of more patients with blood cancers."

Unrelated donor stem cell transplants are generally considered a high-risk treatment due to historically higher rates of disease relapse and GVHD in comparison to stem cells transplanted from donors related to the patients. The results of the study indicated no survival differences between the two groups of patients regardless of age or diagnosis. Relapse rates and incidence of GVHD were also similar. Chronic GVHD, on the other hand, was diagnosed less frequently in patients in the ATG group. In addition, the researchers noticed a higher rate of infections in patients receiving the highest dose of ATG, but this risk was diminished in patients who received slightly lower doses.

This study is one of the first to use ATG in stem cell transplantation. ATG works by reducing the number of circulating T-lymphocytes, a key component of the immune system. It is primarily used in organ transplantation to prevent patients' immune systems from rejecting transplanted tissue. It is also used to treat aplastic anemia, a condition where the bone marrow does not create enough new cells. Currently, there are two types of ATG agents available for clinical use. The one used in this study is derived from rabbit antibodies while the other is derived from horse antibodies.

"Our study results should serve as a guide for designing future clinical trials using ATG to improve outcomes in unrelated donor stem cell transplants," says Toor. "Our findings are encouraging. If many of the risks commonly associated with unrelated donor stem cell transplants are reduced, transplantation becomes an option for more patients."

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The above story is reprinted from materials provided by Virginia Commonwealth University, via EurekAlert!, a service of AAAS.

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Antibodies from rabbits improve survival of leukemia and myelodysplasia patients receiving stem cell transplant

Annabelle magpapa-stem cell na rin

Nakatanggap ako kahapon ng phone call mula kay Annabelle Rama dahil type na rin niya na sumailalim sa stem cell treatment sa Germany.

Sa totoo lang, happy ako dahil na-discover sa Germany ang stem cell treatmentdahil talagang worth it na dayuhin, kesehodang isang araw ang tagal ng biyahe mula sa Pilipinas.

Plano ni Bisaya na gawin ang stem cell treatment sa third week ng July at in-encourage ko siya na ituloy ang kanyang balak dahil maganda talaga ang epekto sa katawan.

Rubby waging 2012 CEO excel

Congrats sa aking friend na si Rubby Sy ng Flawless dahil isa siya sa mga awardee ng 2012 CEO Excel (Communication Excellence in Organizations) na pinili ng Board of Trustees ng International Association of Business Communicators (IABC).

Hindi nakakagulat na napili si Rubby na awardee dahil siya ang sikreto kaya very successful ang Flawless, ang leading facial clinic ng bansa.

Doble ang tagumpay ni Mama Rubby dahil kabilang siya sa mga tumanggap ng Go Negosyo Outstanding Entrepreneur citation. Pararangalan si Mama Rubby ng CEO EXCEL sa awarding ceremonies na gaganapin sa July 12 sa Intercontinental Hotel, Makati City.

Tuwang-tuwa siya siyempre sa parangal na matatanggap niya.

Very thankful siya dahil ang pakiramdam niya, blessed na blessed siya.

We are just really working hard at Flawless every day. This award is a bonus.I couldnt have done it without my equally hardworking team. This award is really for all of us, ang nagpapasalamat na statement ni Mama Rubby.

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Annabelle magpapa-stem cell na rin