Global Clinical Trials, a global mid-sized contract research organization (CRO), has been selected by Israeli biotechnology company BioGenCell to conduct an upcoming Phase II study for the treatment of chronic limb-threatening ischemia (CLI), a painful disease typically affecting heavy smokers and diabetics.
GCT will manage the trial in USA and EU within 7 sites, providing data management, biostatistics, safety and legal representation services as well as clinical monitoring. The primary objectives of the study are safety and efficacy of potential breakthrough cell-based solution for treatment of incurable patients with life-threatening microvascular diseases. BioGenCell’s treatment has already prevented limb loss due to CLI in five previously untreatable patients who had tried every other available option and were about to undergo limb amputation. The company later successfully treated another four.
“GCT is pleased to have been selected for this important project and we look forward to working with BioGenCell. We are hopeful that supporting this research is a significant step in the global effort to find suitable treatment options for patients with vascular diseases, said Dr. Jeffrey T. Apter, GCT President.