Mr. Thomas Smeenk reports
DR. WILLIAM R. SHANKLE TO ADVANCE ACP-01 AS A TREATMENT FOR VASCULAR DEMENTIA
Dr. William R. Shankle, MS, MD, FACP, will lead Hemostemix Inc.'s phase I clinical trial of ACP-01 as a treatment for vascular dementia (VaD).
"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," stated Thomas Smeenk, chief executive officer. "As a leader in this filed, he has approximately 500 individuals diagnosed with cognitive impairment, and is identifying and prescreening up to 30 patients whose condition is primarily vascular in origin to enrol in the trial. Dr. Shankle has consistently advanced the understanding of neurodegenerative and vascular contributions to vascular dementia while maintaining an active portfolio of peer-reviewed publications, clinical research and scholarly activity that continues to influence standards of care in cognitive neurology," Mr. Smeenk said.
About Dr. William R. Shankle and the Shankle Clinic
William R. Shankle, MS, MD, FACP, is a neurologist specializing in the prevention, diagnosis and management of cognitive disorders, including Alzheimer's disease and vascular cognitive impairment/dementia. He is the founder of The Shankle Clinic (Newport Beach, Calif.), established in 1997, a neurology practice focused on neurodegenerative conditions and cognition care.
Dr. Shankle has held academic and clinical leadership roles connected to the University of California, Irvine (UCI) and Hoag's Pickup Family Neurosciences Institute, including co-founding UCI's Alzheimer's Research Center and serving as clinical/program director for memory and cognitive disorders initiatives. He has also been affiliated with UCI's Department of Cognitive Sciences.
Dr. Shankle's selected contributions to vascular dementia and cognition medicine
- Early work contributed to diagnostic frameworks for ischemic vascular dementia, alongside leading figures in dementia research;
- Co-authored peer-reviewed research spanning cognition across aging and dementia -- methodological and clinical perspectives;
- Co-authorship in the leading neurology literature addressing vascular dementia.
Across his career, Dr. Shankle has been featured in clinical programs and public education initiatives aimed at preventing or delaying cognitive decline, while maintaining an active portfolio of publications and scholarly activity.
About ACP-01 and vascular dementia
ACP-01 (Angiogenic Cell Precursors) is Hemostemix's autologous, blood-derived cell therapy designed to promote angiogenesis and microvascular repair. Given the vascular underpinnings of vascular dementia, Hemostemix believes ACP-01 warrants formal clinical study to assess safety, feasibility and preliminary efficacy in patients with vascular contributions to cognitive impairment.
Regulatory steps and recruitment
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. The IRB has provided its initial comments, which Hemostemix and its investigators have now addressed through a set of comprehensive revisions. The revised protocol is being resubmitted for final IRB approval.
As part of the initial recruitment phase, Dr. Shankle is reviewing his patient database of approximately 500 individuals diagnosed with cognitive impairment, to identify and prescreen 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.
Regulatory note: ACP-01 is an investigational, autologous cell therapy. It is not approved by the United States Food and Drug Administration or Health Canada for the treatment of vascular dementia. Any future clinical use will occur strictly within applicable research, ethics and regulatory frameworks.
About Hemostemix Inc.
Hemostemix is an autologous stem-cell therapy platform company, founded in 2003. A winner of the World Economic Forum Technology Pioneer Award, the company has developed, patented, is scaling and selling autologous (patient's own) blood-based stem cell therapy, VesCell (ACP-01). Hemostemix has completed seven clinical studies of 318 subjects and published its results in 11 peer-reviewed publications. ACP-01 is safe, 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. As compared with a five-year mortality rate of 50 per cent in the CLTI patient population, University of British Columbia and University of Toronto reported to the 41st meeting of vascular surgeons: 0-per-cent mortality, cessation of pain, wound healing in 83 per cent of patients followed for up to 4.5 years, as a midpoint result.
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