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Hemostemix Reaches Milestone in the ACP-01 Phase 2 Critical Limb Ischemia Clinical Trial
Hemostemix (TSXV:HEM, OTCQB:HMTXF) has announced an enrollment milestone in its continuing Phase 2 clinical trial for critical limb ischemia (CLI). As quoted in the press release: Enrollment rates have increased substantially over the past several weeks, with an additional nine (9) patients enrolled and treated under the Company’s CLI clinical trial protocol. A total of …
Hemostemix (TSXV:HEM, OTCQB:HMTXF) has announced an enrollment milestone in its continuing Phase 2 clinical trial for critical limb ischemia (CLI).
As quoted in the press release:
Enrollment rates have increased substantially over the past several weeks, with an additional nine (9) patients enrolled and treated under the Company’s CLI clinical trial protocol. A total of thirty-three (33) patients have been treated to date, representing over one third of the total trial enrollment goal.
The Company currently has twelve (12) trial sites open, of which eleven are located in the United States and one in Vancouver, Canada, that are actively screening patients for enrollment in the study. The Company has additional clinical trial sites starting up in Canada and the United States. The Company has been successful in attracting investigators that are top of their field vascular surgeons and podiatrists who are highly regarded for treating CLI patients. The Company continues to see positive interest in ACP-01 as a treatment for advanced CLI patients facing this life-threatening condition and imminent lower extremity amputations.
The clinical trial is a randomized, placebo-controlled, double blind Phase II trial of the safety and efficacy of ACP-01 in patients with advanced CLI who have exhausted all surgical and medical treatment options. Under the current USA Food and Drug Administration (“FDA”) and Health Canada approved protocol, approximately 95 patients will be treated with ACP-01 and followed for twelve months. The Company’s patented ACP-01 autologous stem cells have been shown in previous clinical studies to stimulate the generation of new blood vessels in CLI patients and improve amputation-free survival. ACP-01 is derived from the patient’s own blood, expanded in culture and then re-injected into the diseased tissue.
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