Paper Describing Universal Stem Cell Product Earns Author the 2014 SCTM Young Investigator Award

Durham, NC (PRWEB) February 04, 2015

STEM CELLS Translational Medicine (SCTM) presented Marc H. Dahlke, M.D., Ph.D. its second annual STEM CELLS Translational Medicine Young Investigator Award. The award fosters advancements in the field of stem cells and regenerative medicine by honoring a young researcher who is principle author of an article published in SCTM over the course of a year that is deemed to have the most impact and to push the boundaries of novel and insightful research.

Dr. Dahlkes paper describes the discovery of a universal stem cell product that not only seems to increase the long-term survival of organ transplants in instances when the donor is not related to the recipient, but also retains that immunological privileged state when the organ is then transplanted into yet another unrelated recipient. The paper was published in the August 2013 issue of SCTM.

This excellent study by Dr. Dahlke and his co-authors demonstrate the potential for multipotent adult progenitor cells to serve as a universal cell product. Being able to reduce the level of immunosuppressant drugs post-transplant could have significant benefits to patients, said Anthony Atala, M.D., Editor-in-Chief of SCTM. This study represents a promising pathway for clinical immunotherapy, and I congratulate our Young Investigator Award winner on this important accomplishment.

Dr. Dahlke is a lecturer for experimental surgery at Regensburg University, Germany, and an attending surgeon at Regensburg University Medical Center. He received both his M.D. (in 2002) and his Ph.D. (2004) from Hannover Medical School, where he was enrolled in the program for molecular medicine. He went on to receive specialty training in surgery as a fellow at the University of Sydney (Australia) and at Memorial Sloan Kettering Cancer Center in New York (US).

Currently, his lab in Regensburg focuses on the immunobiology of mesenchymal stem cells and the use of stem cell products for clinical application in solid organ transplantation and other indications. His group publishes regularly in this field, and Dr. Dahlke is the principal investigator of the first phase I study applying a mesenchymal stem cell product to liver transplant recipients.

He also is the founder of the MiSOT network (http://www.misot.eu), which aims to bring together academic and commercial research with the goal of bringing mesenchymal stem cell therapies to the transplantation clinic. He also serves as a reviewer for numerous journals in the immunology field.

The STEM CELLS Translational Medicine Young Investigator Award, which includes a $10,000 cash incentive, is co-sponsored by CIRM and Quintiles in cooperation with the Regenerative Medicine Foundation. Its winner is selected each year by the journals editorial board, made up of leading experts in the field of regenerative medicine worldwide.

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About STEM CELLS Translational Medicine: STEM CELLS TRANSLATIONAL MEDICINE (SCTM), published by AlphaMed Press, is a monthly peer-reviewed publication dedicated to significantly advancing the clinical utilization of stem cell molecular and cellular biology. By bridging stem cell research and clinical trials, SCTM will help move applications of these critical investigations closer to accepted best practices.

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Paper Describing Universal Stem Cell Product Earns Author the 2014 SCTM Young Investigator Award

Stem Cell Therapy, Stem Cell Treatments, Stem Cell Clinics …

With the onset of Alzheimers disease, information transfer at the synapses (the connection between the nerve cells and extensions) starts to break down, and the number of synapses decreases significantly.

Autoimmune diseases are conditions in which the patients immune system generates cellular and antibody responses to substances and tissues normally present in the body.

In each condition there is chronic obstruction of the flow of air through the airways and out of the lungs, and the obstruction generally is permanent and may be progressive over time.

Diabetes is the condition in which the body does not properly process food for use as energy. When you have diabetes, your body either doesn't make enough insulin or can't use its own insulin as well as it should.

Multiple sclerosis (or MS) is a degenerative disease involving the deterioration of nerve cells. MS attacks the central nervous system (CNS), which is made up of the brain, spinal cord, and optic nerves.

Osteoarthritis, or degenerative joint disease, is the most common type of arthritis. It is caused by the degradation of a joints cartilage.

Parkinson's disease is a chronic progressive neurological disease that affects nerve cells (neurons) in an area of the brain known as the substantia nigra.

Rheumatoid Arthritis is an autoimmune disease that attacks the bodys own tissues, specifically the synovium, a thin membrane lining the joints. As a result, joint fluid builds up, causing pain in the joints and inflammation thats systemic.

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Stem Cell Therapy, Stem Cell Treatments, Stem Cell Clinics ...

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TORONTO - Gordie Howe's son says the hockey legend's stroke symptoms have improved since his treatment with stem cells at a Mexican clinic in early December and he wants him to repeat the procedure.

But regenerative medicine experts say there's no scientific evidence such therapies work, and in some cases they can be seriously harmful or even deadly.

The 86-year-old Howe suffered two disabling strokes late last year. In December, the family took him to a Tijuana clinic where he received stem cell injections as part of a clinical trial being run under a licensing agreement with Stemedica Cell Technologies of San Diego, Calif.

The experimental treatment involved injecting neural stem cells into Howe's spinal canal, along with intravenous infusions of mesenchymal stem cells, which are found in bone marrow, fat and umbilical cord blood.

Marty Howe said his father can walk again, his speech is improving and he is regaining some of the weight he lost following the strokes.

"After his stem cell treatment, the doctor told us it was kind of an awakening of the body, and it was all that," he told The Canadian Press while in Calgary for a hockey promotion event Tuesday. "They call it the miracle of stem cells and it was nothing less than a miracle."

However, experts in the field question whether stem cells are responsible for Howe's improvement and caution that most so-called stem cell therapies have not gone through rigorous scientific trials, nor have they been approved as treatments by Health Canada or the U.S. Food and Drug Administration.

Mick Bhatia, director of McMaster University's Stem Cell and Cancer Research Institute, said there are many unknowns in Howe's case, such as how many stem cells were administered, were tests done to see whether they migrated to the targeted area of the body, and did they take up residence where they might have some effect or simply disappear?

"Is this a transient effect, or is it really a perceived or somewhat of a placebo effect and is there something really happening? Scientifically and biologically that is important," Bhatia said Wednesday from Hamilton.

And because Howe received adult stem cells produced from donor cells, he may have needed to take drugs to prevent an immune reaction as well as anti-inflammatory medications, he said.

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ESI BIO A Division of BioTime, Inc. Announces New UK Distribution Agreement with 2BScientific

ALAMEDA, Calif.--(BUSINESS WIRE)--ESI BIO, the stem cell products division of BioTime, Inc., announces that its cGMP and research grade stem cell lines, reagents and cell matrix products are now available in the UK and Ireland through 2BScientific Ltd.

ESI BIOs (esibio.com) research products are used by stem cell researchers around the world and include clinical and research grade human embryonic stem cells from ES Cell International (ESI) and HyStem hyaluronan-based hydrogel extracellular matrices. ESI BIO also provides unique PureStem Embryonic Progenitors, antibodies and small molecules for stem cell differentiation and reprogramming.

Jeffrey Janus, CEO at ESI BIO commented, "We are pleased to hear that 2BScientific would like to be our distributor in the UK market and we expect that we can build a strong partnership in the future." James Bernard, CEO of 2BScientific added, "2BScientific is excited to have signed a distribution agreement with ESI BIO to sell all of their stem cell products and services in the United Kingdom and Ireland. We are excited to offer their cell lines and supporting products for stem cell researchers."

About ESI BIO

ESI BIO - A Division of BioTime, Inc., markets and distributes stem cell related research products provided by BioTime and its subsidiary companies. Many of these products can be provided as a research grade or clinical grade, including ES Cell Internationals human embryonic stem cell lines and HyStem hyaluronan-based hydrogels produced under conditions designed to be compliant with principles of current Good Manufacturing Practices (cGMP), making them suitable for use in clinical research and regenerative medicine. ESI BIO's portfolio includes PureStem human embryonic progenitors, antibodies, and small molecules for stem cell differentiation and reprogramming. ESI BIO's mission is to develop innovative research products that help translate scientific discoveries to the clinic. ESI BIO facilities are located in La Jolla and Alameda, California. Learn more at http://www.esibio.com.

About 2B Scientific

2B Scientific is a specialist distributor of immunological reagents to the UK life science market. 2B Scientific takes a novel approach to life science reagents distribution and provides a wide range of products including antibodies, PCR and flow cytometry reagents, apoptosis assays, proteins and life science consumables. Learn more at http://www.2BScientific.com.

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ESI BIO A Division of BioTime, Inc. Announces New UK Distribution Agreement with 2BScientific

I've been 'scammed': doctor

Winnipeg Free Press - ONLINE EDITION

By: Mary Agnes Welch and Melissa Martin

Posted: 01/18/2015 10:42 PM | Comments:

PHIL HOSSACK / WINNIPEG FREE PRESS Enlarge Image

Medical researcher Doug Broeksas firm, Regenetek, is located at 1213 Chevrier Blvd. in Winnipeg. A family physician who worked with him says she is shocked by revelations he inflated his credentials. Photo Store

The Winnipeg physician who worked closely with a now-discredited medical researcher says she was "duped" by Doug Broeska and is shocked by recent revelations.

"Scammed, yes. Duped, yes," said Susan Hauch, a physician and associate professor at the University of Manitoba medical school. "Weve all been duped."

She said shes shocked by news Broeska inflated his credentials, overstated the effects of the stem cell treatment and was asked recently by an Indian ethics committee to resign as the studys principal investigator because he put patient safety at risk. "Its very unfortunate things had to come out this way because its shattered a lot of lives," Hauch said by phone Sunday. "This has been a very shocking situation."

For the last three years, patients with multiple sclerosis and, more recently, Lou Gehrigs disease, have paid Broeskas Winnipeg company, Regenetek Research, as much as $45,000 to travel to Pune, India, for stem cell treatment. Thats despite ethics rules that bar doctors from charging patients to be part of clinical trials.

While many Regenetek patients saw their MS symptoms shrink, many others did not, and began raising questions about Broeska and his treatment.

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I've been 'scammed': doctor

Agencies mum on Regenetek

Winnipeg Free Press - PRINT EDITION

By: Mary Agnes Welch and Melissa Martin

Posted: 01/16/2015 3:00 AM | Comments:

News that a Winnipeg man falsified his credentials and charged chronically ill people thousands of dollars to participate in a questionable clinical trial has prompted health officials, regulators and police to pass the buck.

Meanwhile, Doug Broeska and his associates, including a Winnipeg physician, are in Trinidad this week preparing to open a new stem-cell clinic.

So far, at least three people have filed complaints with the RCMP about Broeska and his Winnipeg firm, Regenetek Research. The earliest complaints were filed in the summer of 2013 in Alberta and Manitoba. Another complaint was lodged in Saskatchewan last month.

RCMP would not say whether they are actively investigating Broeska and Regenetek. The three people who lodged the complaints told the Free Press they have not been contacted since their initial contact with RCMP.

In the last three years, Regenetek charged about 70 people as much as $45,000 for stem-cell treatment in India that Broeska claimed would halt the progress of multiple sclerosis and, more recently, Lou Gehrig's disease.

"Each and every one of over 60 patients in the trial has demonstrated significant functional improvement with enduring effect," Broeska wrote on his website. "Many have returned to complete health without symptoms, and some have been declared 'disease-free' by their neurologist."

But, a Free Press investigation found at least half a dozen patients experienced no improvement after travelling to India. And Broeska overstated the ethical approvals awarded to his clinical trial and falsified his credentials, claiming to have a PhD when he does not. In December, the Indian hospital where the stem-cell treatments are performed asked Broeska to step down as principal investigator, claiming he was putting patient safety at risk.

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Stem-cell therapy clinic to open in Valley

The new clinic claims its stem-cell treatment can benefit those suffering from emphysema, chronic bronchitis, pulmonary fibrosis and most forms of lung disease.(Photo: Getty Images/iStockphoto)

The Lung Institute, a national clinic that uses adult stem cells extracted from fat and blood to treat pulmonary conditions, is set to open next month in Scottsdale, the for-profit company's first location in the western United States.

The new clinic claims its treatment can benefit those suffering from emphysema, chronic bronchitis, pulmonary fibrosis and most forms of lung disease.

Such stem-cell therapy is part of a growing trend particularly among affluent Americans who can afford it to treat a variety of health problems with cells taken from their own bodies.

The industry remains largely controversial, with plenty of doubters and detractors who say the science is unproven and potentially dangerous.

The International Society for Stem Cell Research, an independent non-profit organization based in Illinois, cautions against the potential risk of some treatments, which it says could cause cancer or result in infection from the procedure itself. The group suggests patients speak with their doctor about the potential benefits or risks of stem-cell therapy.

For its part, Lung Institute says the treatment helps fight lung conditions including chronic obstructive pulmonary disease, one of the world's leading killers. Cells extracted from one organ can create healthy tissue in another organ, the company claims.

The therapy is provided as an outpatient service, and patients can have cells drawn, isolated and planted in the affected area all in the same day. The clinic does not use embryonic, umbilical cord or donor stem cells.

Lung Institute, a clinic that uses stem cells to treat pulmonary conditions, is set to open its first West Coast location in Scottsdale in February 2015.(Photo: Courtesy of Lung Institute)

Patients typically visit the clinic for a few hours over three consecutive days. The treatment seeks to slow disease progression, calm inflammation or repair damaged tissue.

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Stem-cell therapy clinic to open in Valley

Bedford clinic seeks stem cell match for man with leukemia

If youre between 17 and 35 years old, you may be able to save Chris LeBruns life.

LeBrun, 48, was diagnosed with leukemia last May. The accountant and father of two learned last fall that he needs a stem cell donation to beat the disease.

But the donor cant be just anyone. It has to be someone who is a match for the genetic markers in the proteins of LeBruns white blood cells.

That sounds complicated, but the test to find a genetic match is quite simple. Just by swiping the inside of the mouth with a cotton swab, enough cells are collected to determine whether a match has been found.

Donors between 17 and 35 are accepted, and males are preferred, as transplants from men tend to be more successful.

On Saturday in Bedford, 36 people joined the stem cell registry through Canadian Blood Services to try to help LeBrun and others with certain forms of cancer, bone marrow deficiency diseases, anemia and other immune system and metabolic disorders.

LeBrun lives in Cambridge, Ont., but has deep ties to Nova Scotia, says his longtime friend, Barb Leighton.

Leighton describes her friend as a community leader who volunteers tirelessly for causes that are important to him.

Hes very quiet, very humble, very modest, not at all for attention. Complete, pure altruism, she says.

It seems that LeBruns community spirit runs in the family. His great-uncle, Gerald LeBrun, was a well-regarded Bedford doctor who regularly made house calls long after that practice fell out of fashion. Saturdays stem cell clinic was held at the LeBrun Recreation Centre, which was named after the doctor.

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Bedford clinic seeks stem cell match for man with leukemia

Stem Cell Treatment In US – Choosing a Stem Cell Clinic

Its important to recognize that the pace of medical discovery is nothing less than amazing. Initially, there was complete ignorance of stem cells. Then there was the birth of stem cell therapy in the 70-80s, limited to cancers of the blood/lymph system and now as with all changes, there initially is a disbelief period followed by experimental and unproven claims and then finally acceptance. Arthur C. Clarke stated it well, New ideas pass through three periods: 1) It cant be done. 2) It probably can be done, but its not worth doing. 3) I knew it was a good idea all along! We are currently experiencing mild acceptance that stem cell therapy is a medical procedure with potentials. The old school anti-clinical applications groups remain vocal, however they are quickly loosing their impact.

At present the forces of big pharma and regulatory agencies (read the FDA) are dictating your choices, based on the lost revenue models that stem cell therapies may impact, in the US. There is a study suggesting that the stem cell industry will rise to 10% of the current pharmaceutical industrys net revenue in the next 10 years. This represents a 9 Billion dollar challenge to this entrenched big phama, clearly a formable business concern. For those of you interested in the methods of restraint used, read the Code of Federal Regulations Title 21 part 1271. The key words are minimal manipulation and those surrounding the definition of a drug. Your cells become a drug with even a smidgen of treatment and require the full testing and 10+ years of development.

Internationally there has been a much more favorable attitude and many of the most important steps forward are made overseas. The predominant attitude of many international governments is that the implosion of the health care industry in the US will lead to an explosion of medical tourism. A recent survey has foreign hospitals clamoring to achieve JCAHO certification, which stands for Joint Commission on Accreditation of Healthcare Organizations, to assure the public of their quality control. This organization evaluates and certifies hospitals to meet standards and receive Medicare/Medicade funding.

Curiously, many of the tools of the stem cell trade are manufactured in the US. However, the same firms can sell the products domestically if used only for research. They collect a certification statement to this effect, when selling in the US.

Its vitally important that as a consumer of medical services you chose a facility that is unequivocally interested in both an appropriate and well delivered level of services. There are, as with any procedures, risks and benefits. The practice of medicine is both an art and science and requires the correct practitioner, laboratory support and coordination team to provide the highest level of care possible.

This checklist is intended to give you a more precise approach, toward making your medical decisions. Please excuse its length, however a more specific and all encompassing look at this important decision is very significant.

1. There are no guarantees in medicine. The understanding of how the human body functions is still not fully understood. At this time stem cell therapies are not offered as a cure for any disease or a substitute for other forms of care. One of the most potentially misleading approaches to selling medical procedures is the use of anecdotal evidence or personal experiences, regardless of how miraculous they appear. The response of a patient is so individual in nature, without scientific study and collection of data, as to be only a sign of a potential, not proof of a treatments overall effect. ___

2. Does a specific board-certified physician perform the procedures? There are many levels of expertise and only an experienced physician, in the field specific to your disease, should be involved. A board of advisers is helpful and appropriate to have a better opportunity to keep up with the fast pace of medicine, but these individuals are not those administering the actual procedures. ___

3. Are the clinics physicians in compliance with existing medical laws? Although this may seem a strange question, consider the Mexican laws. There they issue a very limited number of licenses, specifically for stem cells, with both allogeneic and autologous limitations. Ask to see a picture of these certifications and check who is listed. Many countries have no regulation and allow any type of physician to perform the procedures. ___

4. Personal experiences with a clinic in regards to their delivery of services, facilities, and personnel should not be relied upon to make a decision for treatment. Its important to feel comfortable, particularly in a foreign country where you will need assistance to navigate and express your needs. At World Stem Cells Clinic we pride ourselves in paving the way toward making your treatments as smooth an experience as possible. Our well-trained team assists you from the start, at the time of contact at the airport, to end of the treatment and with follow-up thereafter. ___

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Report on remission in patients with MS 3 Years after stem cell transplant

Three years after a small number of patients with multiple sclerosis (MS) were treated with high-dose immunosuppressive therapy (HDIT) and then transplanted with their own hematopoietic stem cells, most of the patients sustained remission of active relapsing-remitting MS (RRMS) and had improvements in neurological function, according to a study published online by JAMA Neurology.

MS is a degenerative disease and most patients with RRMS who received disease-modifying therapies experience breakthrough disease. Autologous (using a patient's own cells) hematopoietic cell transplant (HCT) has been studied in MS with the goal of removing disease-causing immune cells and resetting the immune system, according to the study background.

The Hematopoietic Cell Transplantation for Relapsing-Remitting Multiple Sclerosis (HALT-MS) study examines the effectiveness of early intervention with HDIT/HCT for patients with RRMS and breakthrough disease. The article by Richard A. Nash, M.D., of the Colorado Blood Cancer Institute at Presbyterian/St. Luke's Medical Center, Denver, and coauthors reports on the safety, efficacy and sustainability of MS disease stabilization though three years after the procedures. Patients were evaluated through five years.

Study results indicate that of the 24 patients who received HDIT/HCT, the overall rate of event-free survival was 78.4 percent at three years, which was defined as survival without death or disease from a loss of neurologic function, clinical relapse or new lesions observed on imaging. Progression-free survival and clinical relapse-free survival were 90.9 percent and 86.3 percent, respectively, at three years. The authors note that adverse events were consistent with the expected toxic effect of HDIT/HCT and that no acute treatment-related neurologic adverse events were seen. Improvements in neurologic disability, quality-of-life and functional scores also were noted.

"In the present study, HDIT/HCT induced remission of MS disease activity up to three years in most participants. It may therefore represent a potential therapeutic option for patients with MS in whom conventional immunotherapy fails, as well as for other severe immune-mediated diseases of the central nervous system. Most early toxic effects were hematologic and gastrointestinal and were expected and reversible. Longer follow-up is needed to determine the durability of the response," the authors conclude.

(JAMA Neurol. Published online December 29, 2014. doi:10.1001/jamaneurol.2014.3780. Available pre-embargo to the media at http://media.jamanetwork.com.)

Editor's Note: Authors made conflict of interest disclosures. This work was sponsored by the Division of Allergy, Immunology and Transplantation, National Institute of Allergy and Infectious Diseases, National Institutes of Health. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

Editorial: Moving Targets for Stem Cell Transplantation for Patients with MS

In a related editorial, M. Mateo Paz Soldn, M.D., Ph.D., of the University of Utah, Salt Lake City, and Brian G. Weinshenker, M.D., of the Mayo Clinic, Rochester, Minn., write: "This study and another phase 2 single-arm study leave little doubt that high-dose immunotherapy is able to substantially suppress inflammatory disease activity in patients with MS who have active disease in the short term. There is some evidence for long-term suppression of MS. Lessons have been learned about how treatment-related morbidity and mortality may be reduced. However, deaths have occurred, even in small studies, and aggressive regimens have resulted in lymphomas associated with Epstein-Barr virus."

"Nash et al show evidence of prolonged depletion of memory CD4+ cells, depletion of CD4+-dominant T-cell receptor clones and evidence of 'immune reset'; however, clinical or radiologic evidence of relapse trumps immunologic evidence of immune reset, and this study raises concern that those end points have not been adequately achieved. The jury is still out regarding the appropriateness and indication of HCT for MS," the authors conclude.

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Report on remission in patients with MS 3 Years after stem cell transplant