Hemostemix has received all approvals from two new medical centers to be clinical trial sites for its Phase II clinical trial for critical limb ischemia (CLI), the company said in an update on the patient enrolment.
Medical University of South Carolina (MUSC) is located in Charleston, South Carolina, USA with Dr. Thomas E. Brothers, MD as the principal investigator, and it operates a 700-bed medical center.
Moses H. Cone Memorial Hospital (MCMH) is located in Greensboro, North Carolina, USA with Dr. Vance Wells Brabham IV, MD as principal investigator.
Hemostemix said that, with the addition of these two new sites, it now has a total of eleven trial sites now open for patient enrollment, of which ten are located in the United States and one in Vancouver, Canada.
The company expects to grow the number of enrolled patients rapidly with these additional trial sites on-boarded.
The clinical trial is a randomized, placebo-controlled, double blind Phase II clinical testing of ACP-01. About 95 patients will be followed for a minimum period of six months and a maximum a year. The company’s patented process results in specific stem cells that have the ability to support the generation of new blood vessels to combat the life-threatening complications of CLI. The stem cells are differentiated and expanded from the patient’s blood and then re-injected into the diseased tissue, the company said in a press release Wednesday.
Kyle Makofka, President and CEO of Hemostemix, said that the two new sites have recognized heart and vascular centers with leading vascular surgeons acting as principal investigators. Makofka concluded: “The escalation in site enrollment is a positive indication of the interest in our trial and the need for new treatments for CLI that could offer an alternative to life altering amputations which is currently one of the limited treatment options available for some CLI sufferers.”