Blood Derived Autologous Angiogenic Cell Precursor Therapy in Patients With Critical Limb Ischemia (ACP-CLI)



Status:Recruiting
Conditions:Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:11/3/2018
Start Date:August 2014
End Date:December 2022
Contact:Catherine St George
Email:cstgeorge@hemostemix.com
Phone:(587) 435-8605

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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.

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.

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.
We found this trial at
9
sites
Long Beach, California 90822
Principal Investigator: Ian Gordon, MD
Phone: 562-826-8000
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Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Kristina Giles, MD
Phone: 352-273-5482
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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Charlotte, North Carolina 28204
Principal Investigator: Michael Miller, MD
Phone: 704-264-1400
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Charlotte, NC
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Houston, Texas 77030
Principal Investigator: Eric Peden, MD
Phone: 713-441-6537
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Miami, Florida 33126
Principal Investigator: Francisco Perez-Clavijo, DPM
Phone: 786-468-7425
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Philadelphia, Pennsylvania 19140
Principal Investigator: Eric Choi, MD
Phone: 215-707-6144
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San Antonio, Texas 78229
Principal Investigator: Boulos Toursarkissian, MD
Phone: 210-949-0122
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Vancouver, British Columbia
Principal Investigator: York Hsiang, MD
Phone: 604 875-5077
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Winter Haven, Florida 33880
Principal Investigator: Cary J Lambert, MD
Phone: 863-853-5400
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Winter Haven, FL
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