Hemostemix (TSXV:HEM, OTCQB:HMTXF) has announced it has received all its approvals from UC Davis Health to be the location for the company’s Phase II clinical trial for critical limb ischemia. As quoted in the press release: UC Davis Medical Center brings state-of-the-art vascular care to patients throughout Central and Northern California. The Division of Vascular Surgery … Continued
Hemostemix (TSXV:HEM, OTCQB:HMTXF) has announced it has received all its approvals from UC Davis Health to be the location for the company’s Phase II clinical trial for critical limb ischemia.
As quoted in the press release:
UC Davis Medical Center brings state-of-the-art vascular care to patients throughout Central and Northern California. The Division of Vascular Surgery at UC Davis Medical Center has grown to become the largest vascular specialty group in the region. The division is committed to supporting UC Davis Medical Center in its emerging role as a nationally-recognized tertiary care referral center, providing state-of-the-art care for patients with all types of vascular diseases. Clinical and basic science research is one of the core elements of the division. Dr. Matthew W. Mell, M.D, M.S. is the principal investigator for the trial at UC Davis. Dr. Mell specializes in vascular surgery and is the Medical Director of the Vascular Center at UC Davis. He is also a professor and the Chief of Vascular Surgery. Dr. Mell specializes in complex vascular and endovascular surgery, is a well-regarded expert in health policy, and is nationally recognized for his work in aneurysm screening, surveillance, and improving systems of care for treating ruptured abdominal aortic aneurysms.
With the addition of UC Davis, the Company has a total of twelve trial sites now open for patient enrollment, of which eleven are located in the United States and one in Vancouver, Canada. All sites are actively screening patients for enrollment in the study. In addition, the Company also has several clinical trial sites located in Canada and the United States that are in various stages of the on-boarding process. The Company specifically targets strategic clinical sites throughout the United States and Canada that serve large populations or have the demographics to support patient enrollment.
The clinical trial is a randomized, placebo-controlled, double blind Phase II clinical trial to confirm the safety and efficacy of ACP-01. Under the current USA Food and Drug Administration (“FDA”) and Health Canada approved protocol approximately 95 patients will be followed for a minimum period of six months and a maximum of twelve months. 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.