ACP-01 in Patients With Critical Limb Ischemia
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)
1 other identifier
interventional
67
2 countries
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2014
Longer than P75 for phase_2
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 14, 2015
CompletedFirst Posted
Study publicly available on registry
September 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedResults Posted
Study results publicly available
November 18, 2023
CompletedNovember 28, 2023
November 1, 2023
5.7 years
September 14, 2015
September 9, 2023
November 22, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Wound Size, Amputation or Survival
Number of subject with doubling of wound size, major amputation or death
Baseline vs. 1 year
Secondary Outcomes (2)
Pain Level
Baseline vs. 1 year
Ulcer Size
Baseline vs. 1 year
Other Outcomes (5)
Change From Baseline in the Dose and Quantity of Analgesic Drugs Used by the Subject
1 - 52 wks
Reduction in Total Hospitalization Time of Subjects Treated With ACP-01 Compared to Subjects Treated With Placebo
1 - 52 wks
Change From Baseline in Quality of Life
1 - 52 wks
- +2 more other outcomes
Study Arms (2)
ACP-01
ACTIVE COMPARATORInjection into lower extremity
Placebo
PLACEBO COMPARATORInjection into lower extremity
Interventions
Eligibility Criteria
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.
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hemostemixlead
Study Sites (19)
UC Davis CTSC Clinical Research Center
Sacramento, California, 95817, United States
Rocky Mountain Regional VA Medical Center
Aurora, Colorado, 80045, United States
University of Florida
Gainesville, Florida, 32610, United States
Clinovation Research, LLC
Miami, Florida, 33126, United States
Clinical Research of Central Florida
Winter Haven, Florida, 33880, United States
Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
University of Massachusetts Medical School
Worcester, Massachusetts, 01655, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Moses H. Cone Memorial Hospital
Greensboro, North Carolina, 27401, United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Temple University Hosptial
Philadelphia, Pennsylvania, 19140, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Houston Methodist DeBakey Heart & Vascular Center
Houston, Texas, 77030, United States
Clinical Trials of Texas, Inc. (CTT)
San Antonio, Texas, 78229, United States
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1K3, Canada
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
Toronto General Hospital
Toronto, Ontario, M5G 2C4, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Fraser Henderson
- Organization
- Hemostemix
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 14, 2015
First Posted
September 16, 2015
Study Start
August 1, 2014
Primary Completion
April 1, 2020
Study Completion
April 1, 2021
Last Updated
November 28, 2023
Results First Posted
November 18, 2023
Record last verified: 2023-11