Bioheart to Appeal to the FDA for Compassionate Use Designation
Bioheart, Inc. is preparing to request of the FDA’s Center for Biologics Evaluation and Research (CBER) permission to allow access to investigational drugs outside of a clinical trial setting. Bioheart's cell therapy products address an unmet need in the cardiac market by providing true regenerative medicine where the MyoCell® product line may regenerate muscle in areas of scar tissue and the LipiCell® product may help reduce inflammation and promote the growth of new blood vessels.
Expanded access, sometimes called "compassionate use," is the use of an investigational drug outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options. FDA regulations allow access to investigational drugs for treatment purposes on a case-by-case basis for an individual patient, or for intermediate-size groups of patients with similar treatment needs who otherwise do not qualify to participate in a clinical trial.
"We decided to initiate this program as we have had a continuing large number of requests by physicians and patients to make MyoCell® and LipiCell® available on a compassionate basis," said Mike Tomas President/CEO of Bioheart. "Preliminary analysis of interim data results from our cardiac products and centers of excellence suggests that we can safely provide MyoCell® and LipiCell® for treatment of selected cardiac patients, and that the agent has potential to benefit some of these patients. Knowing this information, we believe the ethical choice is to make the drug available on a compassionate use basis."