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Bioheart Inc Announces US FDA Clinical Program Using Adipose Cells


Wednesday, 14 Sep 2011 08:01am EDT 

Bioheart Inc announced that they will begin a US clinical program called the ANGEL trial utilizing adipose derived cells or LipiCell for congestive heart failure patients. Using the clinical data from a Phase I/II trial in Mexico and preclinical studies, Bioheart will apply to the FDA to begin a Phase I study in the US. In collaboration with the Regenerative Medicine Institute of Tijuana, Mexico, six congestive heart failure patients have been successfully treated in a Phase I/II trial at Hospital Angeles Tijuana. The therapy involves the use of stem cells derived from the patient's own fat (adipose tissue) obtained using liposuction. These patients have 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. 

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