Enrollment Milestone In Phase 2 CLI Trial.
CALGARY, Alberta, Canada, April 9, 2019 --Hemostemix Inc. (OTCQB: HMTXF) said it has reached an enrollment milestone in its continuing Phase 2 clinical trial for critical limb ischemia (CLI).
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.
Thirty-three (33) patients have been treated to date, representing over one third of the total trial enrollment goal.
The company has twelve 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 U.S. The company has attracted top investigators who are vascular surgeons and podiatrists 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 2 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 FDA- and Health Canada-approved protocol, approximately 95 patients will be treated with ACP-01 and followed for twelve months.
The 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.
Hemostemix is developing blood-derived cell therapies for medical conditions not adequately addressed by current treatments.
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|Title Annotation:||Clinical Research|
|Publication:||Stem Cell Research News|
|Date:||Apr 22, 2019|
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