Study of stem cell trials links discrepancies in data with reported success of treatment

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28-Apr-2014

Contact: Franca Davenport f.davenport@imperial.ac.uk 020-759-42198 Imperial College London

New research looking at the success of clinical trials of stem cell therapy shows that trials appear to be more successful in studies where there are more discrepancies in the trial data.

Researchers from Imperial College London conducted a meta-analysis of 49 randomised controlled trials of bone marrow stem cell therapy for heart disease. The study, published today in the British Medical Journal, identified and listed over 600 discrepancies within the trial reports.

Discrepancies were defined as two (or more) reported facts that could not both be accurate because they were logically or mathematically incompatible. For example, one trial reported that it involved 70 patients, who were divided into two groups of 35 and 80.

The researchers found eight trials that each contained over 20 discrepancies.

The researchers found that the discrepancy count in a trial was the most important determinant of the improvement in cardiac function reported by that trial. Trials with fewer and fewer discrepancies showed progressively smaller improvements in cardiac function. The five trials with no discrepancies at all showed an effect size of zero (see bar chart in Notes to Editors).

Previous meta-analyses looking at the results of lots of clinical trials have suggested that on average, bone marrow stem cell therapy has a significant positive effect on improving heart function. However, some trials have shown that it successfully improves heart function whilst others have not. The reasons for this are unclear.

Professor Darrel Francis, one of the study authors from the National Heart and Lung Institute at Imperial College London, said: "Clinical trials involve a huge amount of data and so it is understandable that discrepancies sometimes arise when researchers are presenting their findings. However, our study suggests that these discrepancies can have a significant impact on the overall results. It is a powerful reminder to all of us conducting clinical trials to be careful and vigilant to avoid discrepancies appearing in the work.

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Study of stem cell trials links discrepancies in data with reported success of treatment

Stem cell therapies look promising for heart disease

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29-Apr-2014

Contact: Jennifer Beal sciencenewsroom@wiley.com 44-124-377-0633 Wiley

Stem cell therapies work as a complement to standard treatments, potentially cutting the number of deaths after a year, suggests evidence from the latest Cochrane review: Stem cell therapy for chronic ischaemic heart disease and congestive heart failure. Taking stem cells from a patient's bone marrow and injecting them into their damaged heart may be an effective way to treat heart disease.

The new review, published today in The Cochrane Library, uses data involving 1,255 people from 23 randomised controlled trials, where all participants received standard treatments. Compared to standard treatment alone or with placebo, stem cell therapy using bone marrow cells resulted in fewer deaths due to heart disease and heart failure, reduced the likelihood of patients being readmitted to hospital, and improved heart function. However, researchers say that with much larger clinical trials underway, the findings are awaited to enable more certainty about the effects.

Dr Enca Martin-Rendon, author of the review, Cochrane Heart Review Group, and based at NHS Blood and Transplant and the University of Oxford, UK, said: "This is encouraging evidence that stem cell therapy has benefits for heart disease patients. However, it is generated from small studies and it is difficult to come to any concrete conclusions until larger clinical trials that look at longer- term effects are carried out."

Stem cell therapies are experimental treatments that are currently only available in facilities carrying out medical research. If eventually found to be effective, they might offer an alternative or complementary treatment to standard drug and surgical treatments for some patients with chronic heart disease. The procedure involves collecting stem cells from a patient's own blood or bone marrow and using them to repair damaged tissues in the patient's heart and arteries.

Although within the first year there were no clear benefits of stem cell therapy over standard treatment alone, when longer term data were analysed a year or more later about 3 per cent of people treated with their stem cells had died compared with 15 per cent of people in the control groups. Hospital readmissions were reduced to 2 in every 100 people compared to 9 in the control group, and adverse effects were rare.

Dr Martin-Rendon continued, "It isn't clear which types of stem cells work best or why stem cell therapies seem to work for some people but not for others. We need to find out what's different in the people who aren't responding well to these treatments as it might then be possible to tailor therapies to these patients, so that they work better."

Dr David Tovey, Editor-in-Chief, Cochrane, said: "This review should help to raise awareness of the potential of stem cell therapy to improve patient outcomes, but it also demonstrates the importance of recognising the uncertainty of initial findings and the need for further research. A Cochrane review aims to analyse all available data to give a clear picture of what the evidence shows. Ensuring health decision makers, health professionals and the general public has access to up-to-date, relevant evidence research will help to raise awareness of the effectiveness of treatments and medications and therefore improve health care."

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Stem cell therapies look promising for heart disease

Doubts over heart stem-cell therapy

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Chaiwat Subprasom/Reuters/Corbis

Many companies around the world offer stem-cell treatments to patients with heart disease.

An analysis of clinical studies that use adult stem cells to treat heart disease has raised questions about the value of a therapy that many consider inappropriately hyped.

Early-phase clinical trials have reported that adult stem cells are effective in treating heart attack and heart failure, and many companies are moving quickly to tap into this potentially lucrative market. But a comprehensive study that looked at discrepancies in trials investigating treatments that use patients own stem cells, published this week in the journal BMJ (ref. 1), finds that only trials containing flaws, such as design or reporting errors, showed positive outcomes. Error-free trials showed no benefit at all.

The publication comes as two major clinical trials designed to conclusively test the treatments efficacy are recruiting thousands of patients.

The BMJ paper is concerning because the therapeutic approach is already being commercialized, argues stem-cell researcher Paolo Bianco at the Sapienza University of Rome. Premature trials can create unrealistic hopes for patients, and divert resources from the necessary basic studies we need to design more appropriate treatments.

Therapies that use adult stem cells typically involve collecting mesenchymal stem cells from bone marrow taken from the patients hip bone. The cells are then injected back into the patient, to help repair damaged tissue. Original claims that they differentiated into replacement cells have been rejected2, and many clinicians now believe that the cells act by releasing molecules that cause inflammation, with an attendant growth of oxygen-delivering small blood vessels, in the damaged tissue.

The approach has spawned international commercialization of various forms of the therapy, with companies offering treatments for disorders ranging from Parkinsons disease to heart failure. But the effectiveness of such therapies remains unproven.

I have a lot of hope for regenerative medicine, but our results make me fearful.

The BMJ study, led by cardiologist Darrel Francis at Imperial College London, examined 133 reports of 49 randomized clinical trials published up to April last year, involving the treatment of patients who had had a heart attack or heart failure. It included all accessible randomized studies, and looked for discrepancies in design, methodology and reporting of results.

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Doubts over heart stem-cell therapy

Stem Cell Institute Welcomes Special Guest Speaker Roberta F. Shapiro DO, FAAPM&R to Stem Cell Therapy Public Seminar …

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New York, NY (PRWEB) April 29, 2014

The Stem Cell Institute located in Panama City, Panama, welcomes special guest speaker Roberta F. Shapiro, DO, FAAPM&R to its public seminar on umbilical cord stem cell therapy on Saturday, May 17, 2014 in New York City at the New York Hilton Midtown from 1:00 pm to 4:00 pm.

Dr. Shapiro will discuss A New York Doctors Path to Panama.

Dr. Shapiro operates a private practice for physical medicine and rehabilitation in New York City. Her primary professional activities include outpatient practice focused on comprehensive treatment of acute and chronic musculoskeletal and myofascial pain syndromes using manipulation techniques, trigger point injections, tendon injections, bursae injections, nerve and motor point blocks. Secondary work at her practice focuses on the management of pediatric onset disability.

She is the founder and president of the Dayniah Fund, a non-profit charitable foundation formed to support persons with progressive debilitating diseases who are faced with catastrophic events such as surgery or illness. The Dayniah Fund educates the public about the challenges of people with disabilities and supports research on reducing the pain and suffering caused by disabling diseases and conditions.

Dr. Shapiro serves as assistant clinical professor in the Department of Rehabilitation and Regenerative Medicine at Columbia University Medical Center.

Stem Cell Institute Speakers include:

Neil Riordan PhD Clinical Trials: Umbilical Cord Mesenchymal Stem Cell Therapy for Autism and Spinal Cord Injury

Dr. Riordan is the founder of the Stem Cell Institute and Medistem Panama Inc.

Jorge Paz-Rodriguez MD Stem Cell Therapy for Autoimmune Disease: MS, Rheumatoid Arthritis and Lupus

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Stem Cell Institute Welcomes Special Guest Speaker Roberta F. Shapiro DO, FAAPM&R to Stem Cell Therapy Public Seminar ...

Cloning: Scientists make insulin-producing cells

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It was not the first study to create stem cells in this way, but it was the first to use cells sourced from a diseased adult person with the aim of producing therapy-specific cells.

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Scientists said yesterday they had used cloning technology to make embryonic stem cells that carry a diabetic womans genes, and turned them into insulin-producing beta cells that may one day cure her disease.

The team reported clearing an important hurdle in the quest to make personalised stem cells for use in disease therapy, but a bioethicist said the breakthrough also highlighted the need for better regulation of lab-grown embryos.

We are now one step closer to being able to treat diabetic patients with their own insulin-producing cells, said Dieter Egli of the New York Stem Cell Foundation (NYSCF), who led the study published in the journal Nature.

Egli and a team had transplanted the nuclei of cells taken from the womans skin into human eggs to create stem cells, which they could then coax into becoming beta cells a shortage of which causes insulin deficiency and high blood-sugar in diabetics.

In doing so, the team confirmed a potentially important source for future cell-replacement therapy.

It was not the first study to create stem cells in this way, but it was the first to use cells sourced from a diseased adult person with the aim of producing therapy-specific cells.

Insoo Hyun, a bioethicist from the Case Western Reserve Universitys school of medicine in Cleveland, Ohio, said the research, the latest to produce embryonic stem cells that carry the genomes of living people, raised red flags.

This repeated cloning of embryos and generation of stem cells, now using cells collected from adults, increases the likelihood that human embryos will be produced to generate therapy for a specific individual, he wrote in a comment carried by Nature.

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Cloning: Scientists make insulin-producing cells

Mira Richard (Blanche Rachel Mirra Alfassa) – Spirituality – Vedic Astrology – Chart Analysis – Video

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Mira Richard (Blanche Rachel Mirra Alfassa) - Spirituality - Vedic Astrology - Chart Analysis
Panchamahapurusha Yoga, Ruchika Yoga My Blog: http://wheniwentout.blogspot.in/ My Astro Analysis Blog: http://horadiary.blogspot.in/

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Mira Richard (Blanche Rachel Mirra Alfassa) - Spirituality - Vedic Astrology - Chart Analysis - Video