Sunrise, Fla.-based regenerative therapies maker Bioheart Inc. is preparing to ask the FDA to allow "compassionate use" of its cell therapies outside of clinical trial settings.
Bioheart hopes to gain expanded access for its MyoCell and LipiCell treatments in certain heart failure patients who have limited alternative options for treatment, according to a press release.
"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," Bioheart president & CEO Mike Tomas said in prepared remarks. "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," he added.
Bioheart’s flagship MyoCell product is a muscle-derived cell therapy designed to help regenerate cardiac tissue marred by scarring. The LipiCell therapy aims to reduce inflammation and promote new blood vessel growth, according to a press release.
The FDA’s "compassionate use" access allows manufacturers to provide non-approved treatments to doctors dealing with patients who have "a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options."
The federal watchdog agency permits use of such devices based on case-by-case assessments of need or for groups of patients with similar treatment goals who aren’t appropriate for existing clinical trials.
Earlier this month Bioheart launched its ANGEL clinical trial after having raised sufficient funding to run the study, which will evaluate the safety and efficacy of the LipiCell therapy in congestive heart failure patients. The company will enroll the 1st cohort of 5 patients to establish a preliminary safety and efficacy profile.