Hemostemix Expands Clinical Trial for Critical Limb Ischemia (CLI) to Four Sites in South Africa, Treats First South African ParticipantMarch 19, 2015
Multicenter, international, double-blinded trial now operates in Canada and South Africa under the same clinical protocol
Hemostemix Inc. announced today the expansion of its phase II clinical trial for critical limb ischemia (CLI) to four sites in South Africa: Life Kinsgbury Hospital and Mediclinic Cape Gate in Cape Town, Netcare Sunninghill Hospital in Johannesburg, and Netcare Unitas Hospital in Pretoria. Operating under the same phase II protocol as Canadian hospitals in Toronto and Vancouver, the multicenter, international, double-blinded trial has enrolled and treated its first South African participant.
“Adding sites in South Africa to our roster of existing sites in Canada will enable us to significantly expedite enrollment,” said Eilat Bain, director of operations. “We are proud to support the trial with a functional global supply chain from our Israeli manufacturing site.”
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. The double-blind, randomized, placebo-controlled trial targets a participant’s diseased tissue with proprietary cells that are grown from his or her blood and able to support the formation of new blood vessels.
“Approval from the Medicines Control Council to expand this trial in South Africa under the same clinical protocol as our Canadian sites further validates the quality of our ongoing clinical protocol and of our lead product, ACP-01, which contains angiogenic cell precursors,” said Dr. Hardean Achneck, vice president of clinical research and operations at Hemostemix.
“Expanding the trial to South Africa reinforces our commitment to develop a nonsurgical, regenerative cell therapy for CLI patients suffering diminished quality of life,” said Dr. Elmar Burchardt, president and CEO of Hemostemix. “With multiple international trial sites actively recruiting participants, we are gaining valuable clinical experience and expediting the global development process.”
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