GAITHERSBURG, MD--(Marketwire - Dec 6, 2012) - Cytomedix, Inc. ( OTCQX : CMXI ) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, announced today the signing of an agreement with NIH to collaborate on a Phase 2 clinical study in patients with intermittent claudication (IC).IC is caused by peripheral arterial disease (PAD), a condition causing reduced flow of blood and oxygen to muscles of the leg. The study is being funded by NHLBI/NIH and managed by the Cardiovascular Cell Therapy Research Network (CCTRN), which is also responsible for enrolling patients. The CCTRN is a network that includes seven centers in the United States with experience and expertise in stem cell clinical trials studying treatments for cardiovascular heart diseases. The Phase 2 PACE (Patients with Intermittent Claudication Injected with ALDH Bright Cells) study is an 80 patient, double-blind, placebo-controlled clinical trial intended to demonstrate the safety and efficacy of ALD-301 (Bright Cells) in patients diagnosed with IC.The primary endpoints of the study are safety and the change in peak walking time at 6 months compared to baseline.Additionally, changes in leg collateral arterial anatomy, calf muscle blood flow, and tissue perfusion as determined by … Continue reading
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