A Randomized Double Blind Placebo Controlled Clinical Study to Assess Blood-Derived Autologous Angiogenic Cell Precursor Therapy in Patients With Critical Limb Ischemia (ACP-CLI)
The primary objective of this study is to determine the efficacy and safety of intramuscular injection of ACP-01, comprised of blood-derived autologous ACPs, in subjects with critical limb ischemia who are receiving standard of care therapy and have no endovascular or surgical revascularization options.
• Subject is diagnosed with critical limb ischemia.
• Subject has hemodynamic indicators of severe peripheral arterial occlusive disease.
• Subject is not a candidate for standard revascularization treatment options for peripheral arterial disease.
• Subject must be on standard of care medical therapy for peripheral vascular disease.
• Male or female age 18 and above.
• Non-pregnant, non-lactating female.
• Subject is able to understand and provide voluntary signed informed consent.