The Gamida Cell-Teva Joint Venture Concludes Enrollment for the Phase III Study of StemEx(R), a Cord Blood Stem Cell Product, for Leukemia and Lymphoma
The results of the StemEx study are expected during the second half of 2012
Gamida Cell announced today that the Gamida Cell-Teva Joint Venture (JV), equally held by Gamida Cell and Teva Pharmaceutical Industries, has enrolled the last of 100 patients in the international, multi-center, pivotal registration, Phase III clinical trial of StemEx, a cell therapy product in development as an alternative therapeutic treatment for adolescents and adults, with blood cancers such as leukemia and lymphoma, who cannot find a family related, matched bone marrow donor.
StemEx is a graft of an expanded population of stem/progenitor cells, derived from part of a single unit of umbilical cord blood and transplanted by IV administration along with the remaining, non-manipulated cells from the same unit.
Cytori Therapeutics announced today the publication of previously reported six-month outcomes from APOLLO, the Company’s European clinical trial evaluating adipose-derived stem and regenerative cells (ADRCs) in patients with acute myocardial infarction (heart attack or AMI), as Research Correspondence in the Journal of the American College of Cardiology. The APOLLO trial was a 14-patient, prospective, randomized, double-blind, placebo-controlled, feasibility trial (Phase I/IIA) evaluating autologous ADRCs extracted with the Company’s proprietary Celution® System for the treatment of patients suffering from acute myocardial infarction.
In the APOLLO trial all patients were treated with standard-of-care and subsequently underwent an abdominal liposuction. Each patient’s adipose tissue was processed by the Celution® System where ADRCs were extracted, washed and concentrated into a syringe of clinical grade cells. Within 36 hours of the myocardial infarction and no longer than 24 hours after undergoing percutaneous coronary intervention, patients received an injection of either 20 million ADRCs (n=10) or a placebo (n=4).