Bioheart has initiated work on its Regen trial, a Phase I clinical trial to test genetically modified MyoCell in patients suffering from congestive heart failure (CHF).
MyoCell has been tested on patients in four clinical trials. TheRegen 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 company said that the results from the preclinical animal studies have shown that the genetically modified MyoCell is 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 quicker repair. Once that repair or regeneration has occurred, the patient’s improved heart function permits to return to a normal life style.
After completing the Regen trial, the company plans to transition this product into FDA approved Phase II/III Marvel study.
Karl Groth, chairman and chief executive officer of Bioheart, said: “We are proud to be able to commence ourRegen 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 enhance the clinical improvements we have already observed in our Phase II/III MyoCell study.”