Bioheart, Inc, announced that they would be going into the final phase of clinical trial with muscle stem cell in cardiovascular disease treatment.
After reviewing supporting pre-clinical data dating back to 1988 and clinical data from controlled studies which began in early 2000 (nearly 400 patients), a panel of experts strongly endorses moving forward to complete the final phase of clinical trials (MARVEL) to advance muscle stem cell (myoblast) therapy for treating heart failure to mainstream use with FDA approval and CMS reimbursement.
The MARVEL II program aims to streamline both screening and follow-up to facilitate enrollment and to enhance safety monitoring.
During the panel discussion, Dr. Christopher O’Connor, Director Heart Center, Duke University Medical Center commented on the MARVEL program “We believe it is an endeavor worthy of strong support. It is hopeful that MARVEL II, which is one stage of the broader MARVEL program, will meet a key efficacy end point - the six-minute walk.”
Dr. Carl Pepine, MD, Professor of Medicine, University of Florida College of Medicine, discussed the difficulties of stem cell therapy in scar tissue. “Cells of the myoblast variety seem to be able to overcome this barrier…and this is what’s so exciting about the myoblast trials that Bioheart has proposed. We are very encouraged and would like very much to continue these trials.”
Highlights from the call include Dr. Doris Taylor’s, Director, Center for Cardiovascular Repair, University of Minnesota, recollection of the more than 20 years of research in this field. “I’ll never forget the home run. We were able to show that we could grow new muscle in the center of ischemic myocardium and improve functional outcome.” Dr. Nabil Dib, Director, Cardiovascular Research, Mercy Gilbert & Chandler Medical Centers, added that “Myoblast transplantation to patients with congestive heart failure and specifically to scar tissue (not living tissue) has shown that the cells survive, engraft and form new muscle and they do excrete fatigue resistant proteins similar to the heart muscle protein.” Dr. HJ Duckers, Interventional Cardiologist, Thoraxcenter, Rotterdam discussed the history of the Bioheart trials in Europe to date and added that “the myoblast therapy is at this time point the only stem cell therapy that is making the claim to actually induce neomyogenesis and that is why it deserves our attention.”
Dr. Warren Sherman, Director, Stem Cell Research and Regenerative Medicine, Columbia University Medical Center, discussed the anticipated MARVEL study, “this study, once completed, will be the bench mark and we are all very optimistic. Thomas Povsic, Assistant Professor of Medicine, Duke University Medical Center worked directly with the investigational sites on the MARVEL study and commented on “the enthusiasm by the investigators that were involved in the study to get patients in and the enthusiasm that the patients have to get into this study.”
Bioheart’s latest Phase II/III MARVEL study has undergone interim analysis and although data are not disclosed due to pending publication confidentiality, the panel of experts has reviewed these data and has unanimously and enthusiastically endorsed moving forward to finish the pivotal studies to bring this product to FDA approval based on their review.
Research by these experts and others has shown that myoblasts may have an advantage over other cell types in treating heart failure as they can survive in low oxygen environments (such as the damaged areas of the heart), they are committed to becoming muscle, and they are the only progenitor cell in the human body that normally develop the ability to contract making them more likely to restore contractile function of the damaged heart.
About Bioheart, Inc.
Bioheart, Inc. is committed to delivering intelligent devices and biologics that help monitor, diagnose and treat heart failure and cardiovascular diseases. Its goals are to improve a patient’s quality of life and reduce health care costs and hospitalizations.
Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage. Its lead product candidate, MyoCell(R), is an innovative clinical muscle-derived stem cell therapy designed to populate regions of scar tissue within a patient’s heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients.
The Company’s pipeline includes multiple product candidates for the treatment of heart damage, including Bioheart Acute Cell Therapy, an autologous, adipose tissue-derived stem cell treatment for acute heart damage, and MyoCell(R) SDF-1, a therapy utilizing autologous cells that are genetically modified to express additional potentially therapeutic growth proteins. For more information on Bioheart.
Source: PR News Wire