A ground-breaking clinical trial on patients with congestive heart failure is to take place in Jordan in the capital’s Jordan Hospital, according to Dr Karl Groth, Chairman and CEO of Bioheart, Inc.. Bioheart is fueled by a Middle East medical fund, the Ascent Medical Technology Fund II, LP.
The FDA-approved study, REGEN, is set to observe 15 patients with congestive heart failure treated with genetically-modified MyoCell®, a process that uses the patient’s own muscle as a basis for treatment.
Groth said that MyoCell has been successfully tested in four clinical trials and advised that pre-trial research results from studies using Myocell with SDF-1, indicate significant improvement in patients with congestive heart failure (CHF).
“The results of REGEN pre-clinical studies using modified myoblasts show a marked improvement in the heart function of patients with CHF,” said Dr Groth. Groth is also President and CEO of the General Partner, and member of the Ascent Group.
He explained that modified myoblasts induce a higher release of SDF-1 protein, the catalyst that generates stem cells in the body after an injury.
“The research conducted in advance of pre-clinical trials strongly indicates that genetically modified stem cell therapy may increase the speed of repair or regeneration of heart muscles. This means that a patient can return to a normal lifestyle, faster.
We have found that SDF-1 releases additional therapeutic proteins to assist in the tissue repair process, resulting in a more expansive and quicker repair,” said Groth.
The REGEN clinical trial is the first and only FDA-approved clinical study evaluating the therapeutic benefit of combined modified gene-cell therapy for CHF.
Dr. Imad Alhaddad, MD, FACC, FACP and Co-Director of the Jordan Cardiovascular Centre, is Principal Investigator, leading the Study. He said that until now heart muscle damage was considered irreversible and permanent. “As a result of the trials, we can now help regenerate and repair heart muscle using innovative techniques like stem cell therapy. The REGEN trial is the milestone study that will help us achieve these goals.”
Groth added that the REGEN trial is designed to test the safety and effectiveness of the composition of muscle stem cells that have been gene-modified to induce a greater than usual release of the SDF-1 protein.
“We fully expect that this trial will significantly enhance the clinical improvements we have already observed in our Phase II/III MyoCell study,” Groth said.
He explained that unlike other tissues, the heart muscle does not release sufficient SDF-1 to attract the number of stem cells to promote complete self-healing, often resulting in scar tissue formation and an impairment of normal heart function.
According to statistics (American Heart Association), the US spends approximately US$22.5 billion per year on the treatment of patients with heart failure.
After completing the REGEN trial, we plan to transition this second-generation product into its FDA approved Phase II/III MARVEL study.
“Bioheart plans to further study the impact of modified myoblasts by observing three groups; a set of patients who are participating in the study and observing the differences in clinical and heart function among the modified group, those who are treated with MyoCell® alone, and a placebo group, concluded Groth.
