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FDA Approves REGEN Trial To Test Bioheart’s MyoCell SDF-1 In Heart Failure Patients

Bioheart, Inc announced that the US FDA cleared a phase I clinical trial for MyoCell SDF-1 (Stromal Derived Factor - 1) to treat congestive heart failure. The REGEN trial will enroll 15 patients in a multicenter, randomized, dose escalation study. The study will assess the safety and cardiovascular effects of the implantation of MyoCell SDF-1 in congestive heart failure patients post myocardial infarction(s).

We are happy to be able to begin the REGEN trial to test this promising product candidate in heart failure patients after completing very successful preclinical testing, said Howard Leonhardt, Bioheart’s Chairman and CEO. To our knowledge, this will be the first clinical trial ever to test a combination gene and stem cell therapy for cardiovascular disease.

The US trial is expected to begin this year. The company after completing the REGEN safety protocol with one-month follow-up hopes to transition this second-generation product into its FDA-authorized Phase II/III MARVEL study. MyoCell SDF-1 is substantially similar to the original MyoCell composition which has been active in clinical trials from early 2001 at more than 50 centers worldwide.

The patents Bioheart has acquired covering the myogenic cells and SDF-1 compositions and methods are expected to provide intellectual property protection until 2023.