ACP-01 in Patients With Critical Limb Ischemia

Completed · Phase 2 · Has a placebo group

Conditions studied: Critical Limb Ischemia

In brief

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.

Key facts

Study ID

NCT02551679

Run by

Hemostemix

People needed

67

Starts

2014-08-01

Expected to finish

2021-04-01

Last updated by the study team

2023-11-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Uncorrected aorto-iliac occlusive disease.
• Subjects who, in the opinion of the investigator, have a vascular disease prognosis that indicates they would require a major amputation in a time frame shortly after administration of the IMP (investigational drug or placebo).
• Advanced Critical Limb Ischemia (CLI) presenting as severe ischemic or dry gangrene.
• Lower extremity non-treated active infection.
• Hypercoagulable state.
• Subject received a blood transfusion during the previous 4 weeks (to exclude the potential of non-autologous ACPs in the harvested blood).
• Inability to communicate that may interfere with clinical evaluation.
• Recent major non-vascular operation.
• Myocardial infarction or uncontrolled myocardial ischemia or persistent severe heart failure.
• Severe aortic stenosis.
• Renal failure.
• Hepatic failure.
• Anemia.
• Major stroke.
• Diagnosis of malignancy.
• Concurrent chronic or acute infectious disease and uncontrolled infectious symptoms.
• Severe concurrent disease (other than Peripheral Vascular Disease (PAD)).
• Bleeding diathesis.
• Participation at the same time in another investigational product or device study.
• Chronic cytotoxic drug treatment.
• Life expectancy of less than 6 months.
• Subject unlikely to be available for follow-up.
• Acute worsening of CLI.

Where it is running

• UC Davis CTSC Clinical Research Center — Sacramento, California, United States
• Rocky Mountain Regional VA Medical Center — Aurora, Colorado, United States
• University of Florida — Gainesville, Florida, United States
• Clinovation Research, LLC — Miami, Florida, United States
• Clinical Research of Central Florida — Winter Haven, Florida, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• University of Massachusetts Medical School — Worcester, Massachusetts, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Moses H. Cone Memorial Hospital — Greensboro, North Carolina, United States
• Wake Forest Baptist Health — Winston-Salem, North Carolina, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Temple University Hosptial — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — Charleston, South Carolina, United States
• Houston Methodist DeBakey Heart & Vascular Center — Houston, Texas, United States
• Clinical Trials of Texas, Inc. (CTT) — San Antonio, Texas, United States
• Vancouver General Hospital — Vancouver, British Columbia, Canada
• London Health Sciences Centre — London, Ontario, Canada
• Toronto General Hospital — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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