Clinical Research in Ischemic Conditions
Hemostemix conducts regulated clinical research evaluating ACP-01 in ischemic diseases involving impaired blood flow. Our programs are structured under defined protocols, regulatory engagement, and independent ethical oversight.
Clinical Research in Ischemic Conditions
ACP-01 is investigational and has not been approved by the U.S. Food and Drug Administration.
Our clinical programs are conducted under defined regulatory pathways, prespecified safety endpoints, and independent ethical oversight.
Research Strategy and Development Framework
Many ischemic diseases share a central mechanism: impaired perfusion and reduced oxygen delivery to tissues.
Hemostemix has proposed a basket protocol strategy designed to evaluate ACP-01 across multiple vascular-related conditions that share this pathophysiology. This structured development framework allows coordinated research while maintaining:
• Clearly defined inclusion and exclusion criteria
• Prespecified clinical and statistical endpoints
• Defined safety monitoring protocols
• Regulatory engagement across indications
Hemostemix has completed a pre-Investigational New Drug meeting with the U.S. FDA and filed submission 1517 in preparation for advancing ACP-01 across multiple ischemic and vascular indications. Investigational New Drug clearance is required before interventional trials may proceed under U.S. jurisdiction.
Published Clinical Trial Data
Hemostemix completed a Phase II randomized clinical trial evaluating ACP-01 in subjects with chronic limb-threatening ischemia.
The study utilized a randomized, dual-arm design with predefined safety assessments and clinical endpoints. Results were published in the Journal of Biomedical Research and Environmental Sciences, providing peer-reviewed documentation of study methodology and observed findings within a controlled clinical research environment.
ACP-01 remains investigational.
Clinical Trial Announcements and Regulatory Filings
For transparency, Hemostemix provides direct access to clinical trial results, regulatory submissions, and research milestones.
Phase II Randomized CLTI Trial – Published Results
Updated Phase II Clinical Trial Results Published by the Journal of Biomedical Research and Environmental Sciences
FDA Support for Basket Protocol Strategy
Hemostemix Receives FDA Support for Its Basket Protocol Approach
FDA Submission 1517 – Basket Protocol Filing
Hemostemix Files FDA Submission for Basket Protocol Filing 1517 to Advance ACP-01 Across Multiple Ischemic and Vascular Indications
Refractory Angina Added to Phase I Basket Protocol
Hemostemix Receives FDA Support for Its Basket Protocol Approach
Vascular Dementia Research Initiative
Dr. William R. Shankle to Advance ACP-01 as a Treatment for Vascular Dementia
Vascular Dementia Study - Ethics Approval Filing
Hemostemix Files for Ethics Approval of its Study of Vascular Dementia
Cardiovascular Clinical Trial Leadership Appointments
Hemostemix Announces Dr. Giannetti and Dr. Cecere as Co-Lead Medical Consultants for Cardiovascular Clinical Trials
Peer-Reviewed Cardiovascular Research Publication
Hemostemix’s Fourth Heart Study Published in Stem Cell Research & Therapy
Regulatory and Ethical Oversight
Hemostemix structures its clinical research programs in alignment with regulatory standards and ethical oversight principles.
Core elements include:
• Institutional Review Board review and approval
• Clearly defined inclusion and exclusion criteria
• Prespecified safety and efficacy endpoints
• Data integrity safeguards
• Regulatory submissions and IND review processes
Clinical trials conducted under U.S. jurisdiction require Investigational New Drug clearance prior to initiation.
Participation in Clinical Research
Eligibility for participation in clinical research is determined by protocol-specific inclusion and exclusion criteria, regulatory approvals, and geographic considerations.
Individuals interested in learning more about ongoing or upcoming clinical research programs may contact Hemostemix for additional information regarding study status, regulatory progress, and general participation pathways.
ACP-01 is investigational and has not been approved by the U.S. Food and Drug Administration. Participation in clinical research is subject to regulatory clearance and defined study protocols.
Contact our clinical research team to request information about current study programs.
Explore Related Clinical Research
Peripheral Arterial Disease (PAD)
Peripheral arterial disease is characterized by reduced blood flow to the lower extremities. Hemostemix’s PAD clinical research evaluates vascular insufficiency and perfusion-related endpoints under structured study design.
Chronic Limb-Threatening Ischemia (CLTI)
CLTI represents advanced ischemic disease with significant vascular compromise. Hemostemix has completed a Phase II randomized clinical trial in CLTI and continues to evaluate investigational approaches within this indication.
Cardiovascular Ischemia and Angina
Cardiovascular ischemia involves reduced blood flow to the heart muscle and is associated with angina, cardiomyopathy, and heart failure. Hemostemix’s investigational research evaluates vascular-related mechanisms within structured clinical programs.
Vascular Dementia and Cerebral Ischemia
Vascular dementia is associated with impaired cerebral blood flow and vascular injury affecting cognitive function. Hemostemix is advancing investigational research under defined neurological study protocols aligned with its broader ischemic development strategy.
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