COPD & Emphysema Support Group

Osiris Therapeutics Announces Positive Results in Groundbreaking Stem Cell Trial to Treat Heart Disease

Pulmonary Data

Lung function tests were performed to monitor subjects for potential adverse changes related to the treatment. Surprisingly, patients who received PROVACEL had significantly improved pulmonary function following treatment compared to placebo as measured by improvement in FEV1 % predicted values (17 point PROVACEL vs. 6 point placebo, p less than 0.05). Preclinical studies performed at Osiris Therapeutics had previously demonstrated that the anti-inflammatory and anti-fibrotic (anti-scarring) effects of the stem cells may be of benefit to patients with conditions such as Chronic Obstructive Pulmonary Disease (COPD) and Idiopathic Pulmonary Fibrosis (IPF). However, this finding is the first placebo-controlled evidence in humans that indicates MSCs may play a beneficial role in the treatment of certain lung disorders.

The PROVACEL trial is one of five ongoing clinical trials at Osiris, including two Phase III trials using the cells in the treatment of steroid refractory Graft vs. Host Disease and Crohn's Disease, both of which have been granted fast track status by FDA. Osiris is developing PROVACEL as part of a strategic alliance with Boston Scientific Corporation (NYSE:BSX) for commercialization of Osiris' mesenchymal stem cell technology in the cardiac field.

Evaluation of patients in the PROVACEL trial will continue for a total of two years following treatment.

Here's the link
http://tinyurl.com/36586m
Posted on 06/14/07, 01:06 am