(…) 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.
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.
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