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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