A total of 100 patients will be enrolled in the new trial, which will include a randomized control arm and will expand on the results that were showed in the trial in Mexico.
The company along with the team at the Regenerative Medicine Institute in Mexico has been studying the safety and efficacy of using adipose derived cells in many indications.
In one trial, patients with COPD were evaluated for a period of six months.
The new trial has been reviewed and approved by the Institutional Review Board (IRB) of the International Cellular Medicine Society (ICMS) and they have committed to provide peer review of proposed studies of cell-based medical therapies based upon appropriate clinical translation, patient care and safety.
Bioheart is mainly focused on the discovery, development and commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease.