Pluristem Therapeutics Inc. today announced that it has begun enrolling patients in the U.S. for a Phase I clinical trial with its unmatched placenta-derived stem cell product, PLX-PAD, the Company`s leading product candidate for the treatment of critical limb ischemia (CLI), the end-stage of peripheral artery disease (PAD).
Enrollment began at the Center for Therapeutic Angiogenesis in Birmingham, Ala., one of two clinical sites in the U.S. Duke University Medical Center will also be screening patients for the trial. The initiation of this study follows the approval of the Company`s Investigational New Drug (IND) application to begin clinical trials with
Reviewing the technology, business models, intellectual property, regulatory concerns, transplantation and immune rejection.
BioMedReports: There has been some talk about the upcoming opening of your new state-of-the-art facility. Can you tell us about that?
CEO Matthew L. Schissler: We always try to focus on three core goals and in 2010 we are opening our new state of the art laboratory. One of those three core goals is the diversification of revenue streams. Not only will we have our own organic growth engine, by processing and storing for our own company, but we recently entered into a letter of agreement to process and store for another very successful stem cell company. That’s
Aastrom Biosciences, Inc. (Nasdaq:ASTMD), a leading developer of autologous cellular therapies for the treatment of severe cardiovascular diseases, today reported results from a planned interim analysis of the company’s multi-center, randomized, double-blind, placebo-controlled U.S. Phase 2b clinical trial designated RESTORE-CLI. According to the interim analysis the safety profile was similar between the treatment and placebo arms.
Based on a composite efficacy endpoint assessing time to treatment failure (including major amputations, wound size and gangrene), Aastrom’s autologous vascular repair cells (VRCs) were more effective than placebo (P<0.05). Other clinically meaningful endpoints (e.g., major amputation rate, complete wound closure) approached but did
Image by steve p2008 via Flickr
After making news on several occasions, scientists may have made a definitive breakthrough, with the first possible transfusion using blood obtained from embryonic stem cells possibly coming within the next three years. The transfusion would be done with type O blood, which can be donated to any patient, and would be obtained by researchers using excess embryos from assisted fertilization. The project, which will be led by Marc Turner of Edinburgh University, will also receive contributions from the Transfusion and Transplant Service of the British National Health Service, as well as the