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Fifty-six CLI Patients Enrolled At 20 Clinical Trial Sites.

CALGARY, Alberta, Canada, January 17, 2020 -- Hemostemix Inc. (OTC: HMTXF) added a twentieth site for its Phase 2 clinical trial of ACP-01 treatment for critical limb ischemia (CLI), a severe form of peripheral artery disease.

Fifty-six patients are now enrolled.

The Hemostemix Phase 2 study of ACP-01 is an international randomized double-blind placebo-controlled clinical trial to assess the safety and efficacy of ACP-01 injected into the lower extremity of 95 CLI patients who have exhausted all other options.

A futility analysis for potentially stopping enrolment into the study will be performed when 42 subjects have completed at least 26 weeks of follow-up.

Germany, Greece, Netherlands, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Monaco, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.

"ACP-01 has been studied and trialed, with reports published concerning patients suffering from angina, peripheral arterial disease, critical limb ischemia, ischemic and dilated cardiomyopathy," said Thomas Smeenk, president.

NCP-01 will be the subject of an animal study to reverify its safety and preliminary efficacy data as generated in two previous studies.


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Title Annotation:Clinical TRIALS
Publication:Stem Cell Research News
Article Type:Clinical report
Date:Jan 27, 2020
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