Clinical Research on ACP-01 for Vascular and Ischemic Disease

Clinical Burden of Peripheral Arterial Disease

and CLTI

Peripheral arterial disease (PAD) affects more than 200 million individuals globally and represents a major manifestation of systemic atherosclerosis. Progressive disease may lead to chronic limb threatening ischemia (CLTI), characterized by rest pain, non-healing wounds, or tissue loss.

Patients with advanced PAD frequently present with limited revascularization options due to diffuse disease, small vessel involvement, or high operative risk.

Ischemic cardiomyopathy and congestive heart failure similarly reflect impaired tissue perfusion and progressive vascular compromise. Vascular dementia represents vascular-related cognitive decline associated with cerebral microvascular disease.

 ACP-01 clinical research has focused on these areas of unmet need in advanced ischemic disease. 

Mechanism of Action: Autologous Angiogenic Cell Therapy

ACP-01 comprises autologous angiogenic precursor cells derived from a patient’s peripheral blood. Cells are isolated and prepared under controlled laboratory protocols prior to re-administration.

The biological rationale includes:

Support of angiogenesis in ischemic tissue
Modulation of endothelial repair pathways
Potential enhancement of microvascular perfusion
Autologous compatibility minimizing immunologic mismatch

Additional scientific background is available on the ACP-01 therapy page. 

ACP-01 is investigational and continues to be evaluated in clinical research settings.

 Phase II Clinical Evidence in Chronic Limb Threatening Ischemia 

Study Design

Prospective Phase II structured clinical evaluation in patients with advanced CLTI who were not candidates for further revascularization.

Patient Population

Patients diagnosed with advanced peripheral arterial disease progressing to chronic limb threatening ischemia.

Endpoints

Ulcer size reduction
Amputation-free survival
Mortality tracking
Safety outcomes

Key Observations

Published data have reported reductions in ulcer size at defined follow-up intervals compared to baseline measurements. Lower combined amputation or death rates were observed in treated cohorts relative to control groups in reported analyses. Follow-up extended through defined timepoints, with no treatment-related complications reported at one year in published findings.

Detailed study information and references are available in the Clinical Research section. 

Clinical Research in Ischemic Cardiomyopathy and Heart Failure

ACP-01 has been evaluated in patients with ischemic and dilated cardiomyopathy characterized by reduced ejection fraction and symptomatic heart failure.

Structured evaluations have included assessment of:

Left ventricular ejection fraction
Functional capacity measures
Symptom burden
Safety monitoring

Published and retrospective analyses have described changes in cardiac function parameters in defined patient subsets. These findings remain investigational and require further validation through controlled clinical trials.

For additional research summaries:

 Vascular Dementia Clinical Trial Program

Vascular dementia is associated with impaired cerebral perfusion and microvascular ischemic injury.

ACP-01 investigational research in vascular dementia is grounded in its angiogenic and microvascular support rationale. Ongoing and planned studies are designed to evaluate safety and defined cognitive endpoints in selected patient populations.

For patient-facing overview of vascular dementia research:

Study Design, Endpoints and Safety Monitoring

Across evaluated programs, ACP-01 clinical research has incorporated:

Prospective Phase II evaluations
Defined inclusion and exclusion criteria
Intent-to-treat analytical frameworks
Structured safety monitoring protocols
Longitudinal follow-up assessments

Real-world evidence generation under jurisdictional oversight may complement structured clinical research where applicable.

Further randomized and controlled trials are required to determine comparative efficacy and long-term outcomes.

Regulatory Status and Investigational Use

ACP-01 is an investigational therapy and is not approved by the U.S. Food and Drug Administration for general use. Regulatory status varies by jurisdiction.

In select jurisdictions, autologous cellular therapies may be offered within defined regulatory frameworks and under appropriate oversight. Physicians should review applicable local regulations and institutional policies before considering investigational approaches.

Physician Inquiry and Research Collaboration

Physicians seeking additional clinical data, study protocols, peer-reviewed publications, or collaboration discussions may submit a professional inquiry.

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