Bioheart has registered an investigational new drug (IND) application with the US Food and Drug Administration (FDA) to start its Angel trial.
The trial is designed to evaluate autologous adipose derived stem cells’ (LipiCell) safety and cardiovascular effects in chronic ischemic cardiomyopathy patients.
Bioheart has submitted in its IND results from an ongoing Phase I/II trial in Mexico which showed an absolute improvement of 13 % points in ejection fraction and an increase of 100 meters in their 6 minute walk distance.
Bioheart CSO Kristin Comella said they are looking forward to being one of the first companies to bring these therapies to US trials.
"We have successfully showed the safety and efficacy of adipose cells in preclinical studies as well as our clinical trial in Mexico," Comella said.