Preliminary data from bioheart Phase 1 angel trial.
SUNRISE, Fla., October 13, 2014--Bioheart, Inc. (OTCQB: BHRT) released preliminary 12-month data from its self-funded Phase 1 ANGEL trial being conducted in Mexico at the Hospital Angeles in conjunction with the Regenerative Medicine Institute (RMI).
After 12 months, patients are demonstrating a statistically significant average improvement in ejection fraction (EF) by echocardiogram. After three months, all of the patients demonstrated either improvement or stayed the same. Patients showed an average absolute improvement of 3 percentage points in EF.
The patients continued to improve from 3 months to 6 months with a statistically significant average absolute improvement of 10 percentage points (p = 0.01) and at the 12 month follow up patients showed this same level of improvement (p = 0.01).
The company said it was looking forward to expanding this trial to include more clinical sites and patients.
This Phase 1 study will provide necessary safety and preliminary efficacy of adipose derived stem cells (AdipoCell(TM)) in patients with congestive heart failure. Endpoints include safety, exercise capacity, quality of life, and ejection fraction at 3 months, 6 months and 12 months.
|Printer friendly Cite/link Email Feedback|
|Title Annotation:||In The Clinic|
|Publication:||Stem Cell Lab World|
|Date:||Oct 20, 2014|
|Previous Article:||Cardios biosciences allowed to enroll patients in phase 3 clinical trial.|
|Next Article:||First patient treated in neuralstem phase 1 spinal cord injury stem cell trial.|