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Bioheart Approved for Clinical Trial

Bizjournals.com, July 28, 2009

Bioheart announced today that it has received U.S. FDA approval to begin testing it proprietary adult stem cell product, MyoCell SDF-1, for use in the treatment of heart failure. The Phase I clinical trial has a target enrollment of 15 patients and is scheduled to commence later this year.

MyoCell SDF-1 contains autologous (in which the donor and recipient are the same person) adult myogenic stem cells that are derived from each patient's own thigh muscle and which are then genetically modified to produce specific growth factors (such as the cytokine known as stromal cell-derived factor-1) which are involved in the regeneration of muscle tissue. According to Howard Leonhardt, chairman and CEO of Bioheart, "To our knowledge, this will be the first clinical trial ever to test a combination gene and stem cell therapy for cardiovascular disease."

Headquartered in Florida and founded in 1999, Bioheart is focused on the development and commercialization of autologous adult stem cell therapies for the treatment of chronic and acute heart damage. As described on their website, "Our lead product candidate is MyoCell, an innovative clinical therapy designed to populate regions of scar tissue within a patient's heart with autologous muscle cells, or cells from the patient's body, for the purpose of improving cardiac function in chronic heart failure patients. The core technology used in MyoCell has been the subject of human clinical trials conducted over the last six years involving 95 enrollees and 76 treated patients. Our most recent clinical trials of MyoCell include the SEISMIC Trial, a completed 40-patient, randomized, multicenter, controlled, Phase II-a study conducted in Europe and the MYOHEART Trial, a completed 20-patient, multicenter, Phase I dose-escalation trial conducted in the United States."

Additionally, Bioheart has also been cleared by the U.S. FDA to proceed with its "MARVEL Trial" - a 330-patient, multicenter Phase II/III trial of MyoCell to be conducted in North America and Europe. Additional products in Bioheart's pipeline include multiple candidates for the treatment of heart damage such as the Bioheart Acute Cell Therapy, a proprietary formulation of autologous adult stem cells derived from adipose tissue.



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