ACP-01: An Investigational Autologous Stem Cell Therapy for Ischemic Conditions
ACP-01 is an investigational autologous cell product derived from a patient’s own blood and studied in regulated clinical research for ischemic conditions involving impaired blood flow. Ongoing trials evaluate its role within vascular signaling environments under structured safety and regulatory oversight.
ACP-01
ACP-01 is an investigational autologous cell product derived from a patient’s own blood. It contains angiogenic precursor cells that are being evaluated in structured clinical research for their role in ischemic conditions characterized by impaired blood flow and reduced tissue perfusion.
ACP-01 is investigational and has not been approved by the U.S. Food and Drug Administration.
Hemostemix Inc. is a clinical-stage biotechnology company conducting regulated research to evaluate the safety profile and predefined clinical endpoints associated with ACP-01 in vascular-related diseases.
Understanding Ischemia
Ischemia occurs when tissues do not receive sufficient oxygen and nutrients due to reduced blood flow. This reduction in perfusion may occur in:
• Peripheral arteries
• Coronary circulation
• Cerebral vessels
When oxygen delivery declines, tissues shift into a state of metabolic stress. Over time, this may affect cellular signaling, vascular function, and tissue integrity.
ACP-01 is being studied within this ischemic framework.
Why Autologous Matters
ACP-01 is autologous, meaning it is derived from the same individual who receives it.
Unlike donor-derived cellular products, autologous cells originate from the patient’s own biological material.
Because ACP-01 is autologous:
• It does not require donor matching
• It is not associated with graft-versus-host reactions
• It avoids risks related to donor immune incompatibility
Safety and clinical outcomes remain under evaluation within structured research environments.
Autologous Cell Processing Platform
In research settings, the investigational process involves:
• Collection of peripheral blood
• Laboratory processing under controlled conditions
• Concentration of angiogenic precursor cells
• Re-administration within defined clinical protocols
All procedures are conducted within regulated research frameworks and ethical oversight structures.
Mechanism of Action Under Investigation
ACP-01 contains angiogenic precursor cells that are being studied for their involvement in vascular signaling pathways.
In ischemic tissue environments, reduced oxygen tension activates complex biological signaling processes related to angiogenesis and vascular adaptation.
In clinical research settings, ACP-01 is being evaluated for its role in:
• Endothelial signaling pathways
• Microvascular interaction
• Perfusion-related biological processes
• Inflammatory and reparative signaling networks
The precise biological mechanisms and clinical implications remain under investigation. No conclusions regarding therapeutic effect can be drawn outside structured clinical study results.
Safety Monitoring in Clinical Research
ACP-01 research is conducted under structured protocols that include:
• Defined inclusion and exclusion criteria
• Prespecified safety endpoints
• Institutional Review Board oversight
• Regulatory engagement where applicable
Institutional Review Boards independently evaluate clinical research protocols to ensure patient safety, informed consent, and ethical compliance.
Clinical trials conducted within the United States require Investigational New Drug clearance from the U.S. FDA prior to initiation.
Clinical Research History
Hemostemix has conducted multiple clinical studies evaluating ACP-01 in ischemic conditions.
Research milestones include:
• Completion of a Phase II randomized clinical trial in chronic limb-threatening ischemia
• Publication of trial results in the Journal of Biomedical Research and Environmental Sciences
• Pre-Investigational New Drug engagement with the U.S. FDA
• Filing of FDA submission 1517 to advance a proposed basket protocol across multiple ischemic indications
• Institutional Review Board approvals for specific research protocols, including angina
Across completed and ongoing studies, ACP-01 has been evaluated within structured clinical research programs involving hundreds of subjects.
ACP-01 is being evaluated in conditions including:
• Peripheral arterial disease
• Chronic limb-threatening ischemia
• Cardiovascular ischemia and angina
• Vascular dementia
Regulatory Status
ACP-01 is an investigational product.
It has not been approved by the U.S. Food and Drug Administration.
Clinical use outside of approved research protocols depends on regulatory jurisdiction and applicable oversight requirements.
Frequently Asked Questions
What is ACP-01?
ACP-01 is an investigational autologous cell product derived from a patient’s own blood and evaluated in structured clinical research.
What does investigational mean?
Investigational means the product is being studied in clinical trials to evaluate safety and predefined endpoints. It has not been approved for commercial use.
How is ACP-01 different from donor cell therapies?
ACP-01 is autologous and derived from the patient’s own blood. It does not involve donor matching and is not associated with donor-related immune rejection. Safety remains under evaluation.
Is ACP-01 approved by the FDA?
No. ACP-01 has not been approved by the U.S. Food and Drug Administration.
Can patients request ACP-01 treatment?
Participation depends on eligibility criteria within approved research protocols and applicable regulatory pathways.
Disclaimer