Tuesday, 6 May 2014

Bioheart announces update on stem cell trial for heart failure

Bioheart, Inc. a biotechnology company focused on the discovery, development and commercialization of autologous cell therapies, announced yesterday an update on the phase I safety trial using adipose derived stem cells.

About four years ago in April, 2010, Bioheart initiated a study using adipose derived mesenchymal stem cells (AdipoCell™) in congestive heart failure patients. In collaboration with the Regenerative Medicine Institute of Tijuana, Mexico, five congestive heart failure patients were successfully treated in the initial pilot trial at Hospital Angeles Tijuana.

Patients underwent a mini-lipoaspiration procedure where 60ccs of fat were removed. This fat was processed to obtain the stromal vascular fraction (SVF) which contains mesenchymal stem cells, progenitor/endothelial cells, pericytes, hematopoetic stem cells and more. The SVF was injected into the damaged areas of the heart using Bioheart's MyoCath® catheter allowing for a minimally invasive delivery. Patients were followed on protocol for 6 months and demonstrated on average, an absolute improvement of 13 percentage points in ejection fraction and an increase of 100 meters in their 6 minute walk distance.

The patients were recently contacted to assess quality of life. The patients have reported that they are in good spirits and doing well. According to the American Heart Association, about half of the people who develop heart failure die within 5 years of diagnosis. 

The most compelling data from this trial is the strong safety profile. All adverse events were adjudicated by an independent data safety monitoring board and deemed not related to the therapy. In addition, the four year information from the original pilot study demonstrates preliminary long term safety of the AdipoCell product.

"We are pleased that we have been able to help these patients who have very limited options. We are looking forward to collecting additional data on the AdipoCell product and providing these therapies to more patients." said Kristin Comella, Bioheart's Chief Science Officer.
Bioheart's AdipoCell product is currently being studied in a variety of indications including erectile dysfunction, chronic obstructive pulmonary disease and dry macular degeneration.

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