Bioheart, Inc., (OTCBB:BHRT) announced today that the company has
commenced work on its REGEN trial, a Phase I Clinical Trial to test
genetically modified MyoCell® in patients suffering from
Congestive Heart Failure (CHF). Bioheart’s MyoCell® is a
regenerative cell therapy that uses myoblasts, or muscle stem cells,that
are grown from a patient’s own muscle. MyoCell® has been tested
successfully on patients in four clinical trials. The REGEN trial is
designed to test the safety and effectiveness of a composition of muscle
stem cells that have been gene-modified to induce a greater than usual
release of the SDF-1 protein. The SDF-1 protein is a molecule in the
human body that, after an injury, is naturally released by most tissues
to attract stem cells. The stem cells assist with the healing process.
“Seven years of
intense preclinical development, sponsored substantially by Bioheart, at
The Cleveland Clinic with Dr. Marc Penn and the University of Florida
with Dr. Barry Byrne and Dr. Carl Pepine led to this landmark clinical
study.”
Unlike other tissues, the heart muscle does not release enough SDF-1 to
attract the number of stem cells that would result in complete
self-healing. As a result, scar tissue forms and impairs normal heart
function.
Results from Bioheart’s preclinical animal studies have shown that the
genetically modified MyoCell® is far more effective than MyoCell®
alone in accomplishing repair and tissue regeneration. With SDF-1,
there is a release of additional therapeutic proteins to assist in the
tissue repair process, resulting in a more expansive and quicker repair.
Once that repair or regeneration has occurred, the patient’s improved
heart function permits the patient to return to a normal life style.
Karl Groth, Bioheart’s Chairman and Chief Executive Officer says, “We
are extremely proud and excited to be able to commence our
REGEN clinical trial: the first and only FDA-approved clinical study
evaluating the therapeutic benefit of combined modified gene/cell
therapy for CHF. Bioheart's pre-clinical results using this therapy have
demonstrated that our combined gene/cell therapy should significantly
enhance the clinical improvements we have already observed in our Phase
II/III MyoCell® study. As the leader in regenerative
medicine, Bioheart, through its REGEN trial, takes the first step toward
making available a solution for the treatment of heart failure, the most
rapidly growing of all cardiovascular disorders. According to statistics
provided by the American Heart Association, in the US, approximately
$22.5 billion are the direct and indirect annual costs of heart failure
treatment. To bring effective, safe and cost effective clinical
treatments to those with congestive heart failure is our mission.”