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news.Hemostemix announced its progress in expanding the international, multicenter, phase-2 clinical trial of its lead product ACP-01 for critical limb ischemia (CLI) to the US.
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The ongoing phase-2 clinical trial investigates the safety and efficacy of ACP-01, which uses angiogenic progenitor cells to combat the life-threatening complications of CLI.
These proprietary cells are grown from a patient’s own blood and, once injected into his or her diseased tissue, are able to support the formation of new blood vessels.
The clinical trial currently recruits patient at two sites in Canada and four sites in South Africa.
Hemostemix vice president of clinical research and operations Hardean Achneck said: "After receiving clearance from the FDA to recruit patients in the United States, we’ve been engaged in a multistep site-initiation process with qualified medical centers that involves executing nondisclosure agreements and discussing our clinical trial protocol.
"I’m encouraged and inspired by the positive feedback on the design of our clinical trial that we’ve been receiving from vascular surgeons at such leading U.S. medical centers as Houston Methodist DeBakey Heart & Vascular Center, University of California Davis Vascular Center, Ronald Reagan UCLA Medical Center, Temple University, Malcom Randall Veterans Affairs Medical Center, and Yale University. We are discussing the terms of contractual agreements with some of these sites, and several sites are currently in the process of submitting study documents to their respective institutional review boards."
Hemostemix president and CEO Elmar Burchardt said: "Leading medical centers in the United States are increasingly recognizing the groundbreaking potential of our lead product ACP-01 for the treatment of CLI.
"There is tremendous need for a therapy that reduces the number of limb amputations and improves survival. ACP-01 gives hope to patients who suffer from CLI and to physicians who lack other treatment options."
About Critical Limb Ischemia (CLI)
CLI is a severe form of peripheral artery disease (PAD) caused by reduced blood flow to the legs. About half of CLI patients either die or require amputation of the affected limb within one year of diagnosis. Demand for a treatment is on the rise, as CLI predominately affects the growing population aged 50 and older.