ACP-01 in Patients With Critical Limb Ischemia
Condition: Critical Limb Ischemia
MeSH terms: Chronic Limb-Threatening Ischemia; Ischemia
Intervention: ACP-01; Placebo
Intervention description: Injection into lower extremity; Injection into lower extremity
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Stem cells; Autologous; Vascular disease; Peripheral arterial disease; Regenerative medicine; Amputation

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 criteria:

        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.