Calgary, Alberta — November 20, 2025 — Leads & Copy —
Hemostemix Inc. (TSXV: HEM, OTCQB: HMTXF, FSE: 2VF0) has announced that Dr. William R. Shankle will lead the Phase I clinical trial of its VesCell™ (ACP-01) therapy as a treatment for vascular dementia (VaD).
Dr. Shankle, a neurologist specializing in cognitive disorders, is the founder of The Shankle Clinic in Newport Beach, CA. He has held leadership roles at the University of California, Irvine (UCI) and Hoag’s Pickup Family Neurosciences Institute, and has been affiliated with UCI’s Department of Cognitive Sciences.
According to a press release issued November 20, 2025, Hemostemix believes that ACP-01 warrants formal clinical study to assess its safety, feasibility, and preliminary efficacy in treating patients with vascular contributions to cognitive impairment, given the vascular underpinnings of vascular dementia.
Dr. Shankle is reviewing his patient database of roughly 500 individuals diagnosed with cognitive impairment to identify and pre-screen up to 30 patients whose condition is primarily vascular in origin. This cohort may form the foundation for subject enrolment and baseline characterization in the Phase 1 study, which is designed to assess ACP-01’s safety, feasibility, and potential cognitive benefits in vascular dementia.
The Phase 1 vascular dementia protocol, co-authored by Dr. Fraser Henderson Sr. and Dr. William R. Shankle, has been formally submitted to an Institutional Review Board (IRB) for ethical review and approval.
ACP-01 (Angiogenic Cell Precursors) is Hemostemix’s autologous, blood-derived cell therapy designed to promote angiogenesis and microvascular repair.
Hemostemix is an autologous stem cell therapy platform company that developed, patented, is scaling and selling autologous (patient’s own) blood-based stem cell therapy, VesCell™ (ACP-01). The company has completed seven clinical studies of 318 subjects and published its results in eleven peer reviewed publications. ACP-01 is clinically relevant and statistically significant as a treatment for peripheral arterial disease, chronic limb threatening ischemia, non ischemic dilated cardiomyopathy, ischemic cardiomyopathy, congestive heart failure, and angina. Hemostemix completed its Phase II clinical trial for chronic limb threatening ischemia and published its results in the Journal of Biomedical Research & Environmental Science.
Thomas Smeenk, President and CEO of Hemostemix, highlighted Dr. Shankle’s extensive experience and contributions to understanding neurodegenerative and vascular contributions to vascular dementia.
Regulatory note: ACP-01 is an investigational, autologous cell therapy and is not approved by the U.S. FDA or Health Canada for the treatment of vascular dementia. Any future clinical use will occur strictly within applicable research, ethics, and regulatory frameworks.
Thomas Smeenk, President, CEO EM: tsmeenk@hemostemix.com / PH: 905-580-4170
Source: Hemostemix Inc.
