Dr. William R. Shankle to Advance ACP-01 as a Treatment for Vascular Dementia

Executive Summary

• Hemostemix Inc. announced that Dr. William R. Shankle will lead a Phase I clinical trial of its autologous cell therapy ACP‑01 (VesCell™) for vascular dementia.
• The trial protocol has been revised and resubmitted to the Institutional Review Board for final approval; up to 30 pre‑screened patients are being identified from Dr. Shankle’s database of ~500 cognitively impaired individuals.
• This represents Hemostemix’s first formal investigation of ACP‑01 in a neurodegenerative indication, expanding its therapeutic portfolio beyond cardiovascular and peripheral vascular diseases.

Key Details

• Lead Investigator: Dr. William R. Shankle, MS, MD, FACP – neurologist and founder of The Shankle Clinic (Newport Beach, CA).
• Trial Scope: Phase I, safety‑feasibility study of ACP‑01 in patients with vascular contributions to cognitive impairment (vascular dementia).
• Patient Recruitment: Dr. Shankle will pre‑screen up to 30 candidates from his practice’s ~500 diagnosed individuals; these subjects form the anticipated enrollment cohort.
• Regulatory Status: Protocol co‑authored by Dr. Fraser Henderson Sr. and Dr. Shankle has been submitted to an IRB, received initial comments, and is being resubmitted after revisions for final approval.
• Therapeutic Candidate: ACP‑01 (Angiogenic Cell Precursors) – autologous, blood‑derived cell therapy designed to promote angiogenesis and microvascular repair; currently investigational and not FDA or Health Canada approved for any indication.
• Company Background: Hemostemix has completed seven clinical studies (318 subjects) across cardiovascular indications; Phase II CLTI trial showed 0% mortality and 83% wound‑healing in a mid‑point analysis.
• Forward‑Looking Statements: The release contains forward‑looking information regarding the Phase I trial, future regulatory approvals, potential commercialization pathways, and financing needs.

Notable Quotes

“Across his more than 35 years of medical practice, Dr. Shankle has been featured in numerous clinical programs and public education initiatives dedicated to the prevention, early diagnosis, and management of cognitive decline,” – Thomas Smeenk, CEO, Hemostemix.

“Dr. Shankle has consistently advanced the understanding of neurodegenerative and vascular contributions to vascular dementia while maintaining an active portfolio of peer‑reviewed publications…” – Thomas Smeenk, CEO, Hemostemix.