ACP-01 in Patients With Critical Limb Ischemia

Critical Limb Ischemia Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02551679
• Other study ID #: HS 12-01.
• Status: Completed
• Phase: Phase 2
• Start date: August 2014
• Est. completion date: April 2021

Study information

• Verified date: November 2023
• Source: Hemostemix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This prospective, randomized, double-blind, placebo controlled study will assess the efficacy and safety of autologous ACPs administered intramuscularly into the lower extremity of subjects with CLI who lack surgical or endovascular revascularization options.

A total of approximately 95 subjects will be randomized to treatment with ACP-01 or placebo using a 2:1 randomization scheme, respectively, stratified by site.

The study will continue until all subjects treated experience the study event (either de novo gangrene, doubling of wound size, major amputation, or death) or are event-free for at least 26 weeks. Subjects treated will be followed for no longer than 52 weeks.

One futility analysis for potentially stopping study enrollment will be performed.

Subjects treated at each investigative site will provide written informed consent prior to the conduct of any study-related procedures. Thereafter, they will be screened and those meeting the inclusion/exclusion criteria will be enrolled into the trial and undergo all the study procedures including intramuscular injection of the investigational medicinal product (IMP = ACP-01 or placebo). The IMP will be administered in addition to any conventional treatment the subject is receiving.

The control group will receive placebo injections into the lower extremity to ensure blinding of the assessors and the subjects.

The placebo will consist of the same medium used in the ACP product suspension.

The study consists of four periods: Screening period, Treatment period, Acute safety follow-up and Long term follow-up periods. The total duration of study participation, including follow-up, is at least 26 weeks. Subjects will be followed for up to 52 weeks and at least until the last subject has completed his/her 26 week visit.

Other known NCT identifiers

• NCT02140931

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 2021
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Chronic Limb-Threatening Ischemia
• Critical Limb Ischemia
• Ischemia

Intervention

Biological:
• ACP-01
Injection into lower extremity
• Placebo
Injection into lower extremity

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Hemostemix

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change From Baseline in the Dose and Quantity of Analgesic Drugs Used by the Subject		1 - 52 wks
Other	Reduction in Total Hospitalization Time of Subjects Treated With ACP-01 Compared to Subjects Treated With Placebo		1 - 52 wks
Other	Change From Baseline in Quality of Life	Change in quality of life according to the Vascular Quality of Life Questionnaire.	1 - 52 wks
Other	Change From Baseline in Ankle Pressure		1 - 52 wks
Other	Change From Baseline in Toe Pressure		1 - 52 wks
Primary	Wound Size, Amputation or Survival	Number of subject with doubling of wound size, major amputation or death	Baseline vs. 1 year
Secondary	Pain Level	Change in pain score according to the Visual Analog Scale (VAS) for Pain. The visual VAS is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between the two ends of the scale-"no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). Measurements from the starting point (left end) of the scale to the subjects' marks are recorded in centimeters and are interpreted as their pain. The values ar used to track pain progression for a subject and to compare pain between subjects.	Baseline vs. 1 year
Secondary	Ulcer Size	Change in ulcer size	Baseline vs. 1 year

External Links

•   Hemostemix Inc. website