Cytomedix, a regenerative therapies company focused on the development of innovative platelet and adult stem cell technologies, has inked an agreement with the National Institute of Health (NIH) to collaborate on a phase 2 clinical study of patients with intermittent claudication (IC), a condition that causes reduced flow of blood and oxygen to muscles in the leg.
The study is being funded by the National Heart, Lung and Blood Institute/NIH, and will be managed by the Cardiovascular Cell Therapy Research Network (CCTRN), which will also assume responsibility for patient enrollment.
The phase 2 PACE (Patients with Intermittent Claudication Injected with ALDH Bright Cells) study is an 80 patient, double-blind, placebo-controlled clinical trial designed to demonstrate the safety and efficacy of ALD-301 (Bright Cells) in patients diagnosed with IC. The study will be the first randomized clinical trial to demonstrate the benefits of autologous stem cell therapy in PAD patients with IC.
In addition, researchers will examine changes in leg collateral arterial anatomy, calf muscle blood flow, and tissue perfusion via magnetic resonance imaging (MRI) to potentially support the angiogenic mechanism of Bright Cells.
Cytomedix in February acquired Aldagen and the Bright Cell technology, a move that CEO Martin P. Rosendale says puts Cytomedix in a favorable position to investigate promising clinical paths in regenerative medicine, in synch with today's agreement.
"We look forward to supplying a highly differentiated personalized cell therapy product to the participating CCTRN centers involved with this important PAD indication. Intermittent claudication is a serious consequence of arteriosclerosis which, if left untreated, will likely progress to pain at rest and possibly open wounds," Rosendale stated in the press release. "Our experience with the AutoloGel product and the clinical treatment of lower extremity wounds resulting from CLI has provided us with a full appreciation of the difficult clinical outcomes associated with this compromised patient population. We are hopeful that improvements in lower leg blood flow will lead to increased peak walking time which has been accepted as an FDA approvable endpoint in pivotal phase 3 trials in IC."
The clinical study has received Investigational New Drug approval from the U.S. Food and Drug Administration (FDA). CCTRN plans to commence patient enrollment in the first quarter of 2013 upon the Investigational Review Board approvals from the participating centers.
For more information, visit cytomedix.com
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