RANCHO CORDOVA, Calif. and GURGAON, India, June 10, 2014 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (Nasdaq:KOOL) an autologous cell-based regenerative medicine company, today announced longer-term follow up from its feasibility study of SurgWerks®-CLI, its candidate therapeutic device kit for treating Rutherford category 5 and Fontaine IV (end-stage) critical limb ischemia (“CLI”). The Safety and Efficacy of Autologous Bone Marrow Mononuclear Cells in Patients with Severe Critical Limb Ischemia (NCT01472289) was a single center, unblinded, single arm study in 17 patients with late-stage CLI. The original study results were announced in January 2014. This extended six month follow-up period beyond the study closure at 12 months was approved as a protocol amendment by the central Institutional Ethics Committee of Fortis Escorts Heart Institute (New Delhi) specifically to measure certain safety endpoints. One such safety endpoint is to ensure that vasculogenesis occurs in the targeted treatment limb but not in other areas of the body. The standard for assessing undesired neovasculogenesis is the assessment of the fundus (eye retinal bed) for changes in vascularity over time. The other safety endpoints evaluated were specific to serious adverse events including new amputation procedures or rehospitalization.
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