Clinical Research in Ischemic Conditions
Clinical Research in Ischemic Conditions
Hemostemix is evaluating ACP-01, an investigational autologous cell therapy, across multiple conditions that share a common root cause: impaired blood flow and reduced oxygen delivery to tissue. This page is for patients who want to understand the science, and for physicians who want to evaluate the research.
ACP-01 is investigational and has not been approved by the U.S. Food and Drug Administration.
Our Research Approach
Most investigational therapies are studied one condition at a time. Hemostemix is taking a different approach.
Because PAD, CLTI, cardiovascular ischemia, and vascular dementia all share the same fundamental problem, blood vessels that can no longer deliver adequate oxygen to the tissues they serve, we are evaluating ACP-01 across all four conditions simultaneously under a single coordinated research framework called a basket protocol.
This approach allows us to study shared vascular mechanisms across multiple indications at once, advance findings from one condition to inform research in others, and move the science forward without sacrificing rigor or patient protections. Every program operates under clearly defined eligibility criteria, prespecified safety endpoints, and independent ethical oversight.
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.
Where We Are
Hemostemix has been advancing structured clinical research in ischemic conditions for over two decades. The milestones below reflect our regulatory progress, published science, and ongoing development activity.
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
Our Research Standards
Physician Leadership
ACP-01 research is being advanced under the direct leadership of specialist physicians with deep clinical expertise in the conditions being studied. Our research team includes specialists in vascular medicine, cardiology, and cognitive neurology who bring rigorous clinical judgment to every aspect of study design, patient evaluation, and safety monitoring.
Physician led research is not just a regulatory requirement for Hemostemix. It is how we ensure that every protocol reflects real clinical understanding of the patients we are trying to help.
Regulatory and Ethical Oversight
Every ACP-01 research program is structured under independent ethical oversight and defined regulatory standards. This is not a formality. It is the framework that protects patients, ensures data integrity, and maintains the credibility of every finding we publish.
All research programs include Institutional Review Board review and approval before any patient participation begins, clearly defined inclusion and exclusion criteria, prespecified safety and clinical endpoints, independent safety monitoring throughout the study, and regulatory submissions reviewed under U.S. FDA oversight.
Clinical trials conducted under U.S. jurisdiction require Investigational New Drug clearance from the FDA prior to initiation. Hemostemix does not proceed without it.
Get Involved in Clinical Research
Whether you are a patient exploring investigational options or a physician evaluating ACP-01 for a patient in your care, the next step is a conversation with our clinical research team.
For Patients
If you have been diagnosed with PAD, CLTI, cardiovascular ischemia, or vascular dementia and continue to experience symptoms despite standard treatment, a clinical evaluation may help determine whether investigational research is appropriate for your situation. Our team reviews each case individually and is committed to honest, transparent communication about what this process involves and what it does not.
For Physicians
If you have a patient with advanced ischemic disease who has exhausted standard revascularization or treatment options, we welcome physician initiated referrals and clinical inquiries. Our team can provide detailed information about current study status, eligibility criteria, and the evaluation process.
Explore Related Clinical Research
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.
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.
Request A Clinical Research Consultation
Request A Clinical Research Consultation
If you have been diagnosed with an advanced vascular or ischemic condition and are exploring investigational clinical research options, you may request a consultation to determine whether further review is appropriate.
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