NCT02551679

ACP-01 in Patients With Critical Limb Ischemia

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)

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.

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.

Disease(s) and\or Condition(s)

Critical Limb Ischemia

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: BIOLOGICAL
    • Name: ACP-01
    • Description: Injection into lower extremity
    • Arm Group Labels: ACP-01
    • Type: BIOLOGICAL
    • Name: Placebo
    • Description: Injection into lower extremity
    • Arm Group Labels: Placebo
Sponsor
  • Hemostemix