When Revascularization Fails,
What Do You Offer Your No-Option Patients? 

ACP-01: Autologous Angiogenic Cell Therapy Under Investigation for Advanced Ischemic Disease

 

The Challenge You Face Daily

Critical limb-threatening ischemia (CLTI) patients with no revascularization options. Limited pathways. High amputation rates. Mortality risk. You're looking for credible alternatives backed by science—not promises.

 

The Scientific Approach

ACP-01 is an investigational autologous angiogenic cell therapy being studied for its potential role in supporting angiogenesis and microvascular repair in ischemic tissue. Early clinical research suggests potential for limb salvage, support of wound healing processes, and improved perfusion in no-option CLTI, cardiac angina, and cardiomyopathy.

 

ACP-01 is not FDA approved. Treatment is available in Florida under SB 1768, Toronto under compassionate access, and through licensed physicians outside FDA jurisdiction in the Bahamas and Dominican Republic.

 

Early Clinical Evidence: CLTI

83%

Limb Salvage Rate

(Phase II Data)

146→0.48mm2

Ulcer Closure

(Published Outcomes)

70% vs 25%

Limb Salvage

vs Control Group

Data from peer-reviewed publications. ACP-01 is investigational.

 

How ACP-01 Works

Autologous Angiogenic Cell Precursors

ACP-01 is derived from the patient's own peripheral blood and enriched for endothelial progenitor cells (EPCs). Research suggests these cells may support:

  • Angiogenesis: Formation of new microvasculature
  • Endothelial repair: Restoration of damaged vessel lining
  • Perfusion improvement: Enhanced blood flow to ischemic tissue
  • Tissue viability support: Promoting wound healing processes
 

Peer-Reviewed Publications

Critical Limb-Threatening Ischemia (CLTI)

Angiogenic Precursor Cell Treatment of Critical Limb Ischemia Decreases Ulcer Size, Amputation and Death Rate: Re-Examination of phase II ACP NO-CLI Trial Data

Autologous stem cell treatment for CLI patients with no revascularization options: ACP-01 4.5-year clinical update

Peripheral blood-derived autologous stem cell therapy for the treatment of patients with late-stage peripheral artery disease: Results of the short and long-term follow-up

Enhancing limb salvage by non-mobilized peripheral blood angiogenic cell precursors therapy in patients with critical limb ischemia

Angina, Ischemic & Non-Ischemic Dilated Cardiomyopathy

Treatment of Patients with Severe Angina Pectoris Using Intracoronarily Injected Autologous Blood-Borne Angiogenic Cell Precursors

Safety and outcomes analysis: transcatheter implantation of autologous angiogenic cell precursors for the treatment of cardiomyopathy

Intramyocardial Angiogenic Cell Precursor Injection for Cardiomyopathy. Asian Cardiovasc Thorac Ann 2008;16:143-148

Transcoronary Injection of Angiogenic Cell Precursors an Autologous Stem Cell in Ischemic Cardiomyopathy: A Clinical Study of 106 Cases

Mechanisms of Action & Preclinical

Angiogenic Cell Precursors and Neural Cell Precursors in Service to the Brain-Computer Interface

Isolation of an adult blood-derived progenitor cell population capable of differentiation into angiogenic, myocardial and neural lineages

Human angiogenic cell precursors restore function in the infarcted rat heart: A comparison of cell delivery routes

Important Regulatory Context: ACP-01 is an investigational therapy and is not FDA approved. Treatment is legally available in Florida under state law SB 1768, in Toronto under compassionate access provisions, and through licensed physicians outside FDA jurisdiction in the Bahamas and Dominican Republic. 

Is ACP-01 Right for Your Practice?

Consider ACP-01 for patients with:

Treatment available in Florida (SB 1768), Toronto (compassionate access), and through licensed physicians outside FDA jurisdiction (Bahamas, Dominican Republic)

No-option CLTI
Failed or non-candidate for revascularization

Non-healing wounds
Chronic ulcers, tissue loss, amputation risk

Refractory angina
Persistent symptoms despite maximal therapy

Cardiomyopathy
Ischemic or non-ischemic heart failure