Safety and Efficacy of Allogeneic Cells for the Treatment of Intermittent Claudication(IC)

Inclusion Criteria:

• Male or female subjects between 45 to 80 years of age (inclusive) at the time of screening visit.

• Diagnosis of peripheral artery disease, secondary to atherosclerosis, confirmed by one of the following criteria assessed at the screening visit:

  • Resting ankle-brachial index (ABI) < 0.80 or
  • Resting ABI < 0.90 and >20% decrease in ABI from rest to exercise when measured within 1 minute after treadmill exercise or
  • Toe-brachial index (TBI) < 0.60
• Lifestyle-limiting, moderate to severe claudication (symptoms present and stable for > 6 months and not significantly changed within the past 3 months prior to screening)
• Evidence of significant (>50%) stenosis infra-inguinal occlusive disease as confirmed by documented results from Duplex, MRA, CTA and/or contrast angiogram completed within 3 months prior to screening
• The longest maximal walking distance (MWD) from the Screening Period exercise treadmill tests (ETT), utilizing a modified Gardner Protocol (Appendix I), must be between 1 and 10 minutes (inclusive).
• Persistent claudication symptoms despite having been recommended an exercise program if feasible, and or despite having been on a stable dose of Cilostazol,if indicated,
• Subjects should be receiving standard of care drugs for vascular disease including antiplatelet agent(s) and statin medication, as well as anti-hypertensive medication(s) and oral hypoglycemic agents/insulin, if indicated.

Exclusion Criteria:

• Ischemic rest pain; ulceration or gangrene (Fontaine class III-IV; Rutherford category 4-6).
• Failed lower extremity arterial reconstruction (surgical or endovascular) or sympathectomy within the prior one month of screening.
• Planned revascularization within 3 months of screening.
• Lower extremity arteries inflow obstruction (defined as a greater than 50% stenosis of aorta, iliac and/or common femoral arteries)
• Planned surgical or endovascular intervention in the next 12 months
• History of Buerger's disease.
• Uncontrolled hypertension (diastolic > 100 mmHg or systolic > 081 mmHg during screening).
• Uncontrolled diabetes -HbA1c > 9% at screening.
• Life-threatening ventricular arrhythmia - except in subjects with an implantable cardiac defibrillator.
• Unstable cardiovascular disease defined as myocardial infarction (STEMI or NSTEMI)within 3 months prior to screening, or unstable angina - characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged episodes.
• Transient Ischemic Attack (TIA)/Stroke within 3 months prior to screening.
• Severe CHF symptoms (i.e. NYHA Stage III to IV).
• Implant of mechanical prosthetic heart valve(s).
• Severe, active infection of the involved extremity(ies), including osteomyelitis, fasciitis,or severe/purulent cellulitis.
• History of malignancy within 1 year prior screening requiring chemotherapy and/or radiotherapy and/or immunotherapy therapy.
• Exercise is limited by any condition other than IC, including (limited to but not including) congestive heart failure, chronic pulmonary disease, angina pectoris, or degenerative joint disease.
• Uninterrupted use of warfarin or non-steroidal anti-inflammatory agents (with the exception of ibuprofen at doses up to 1,200 mg/day or Diclofenac at dose of 75mg/day).
• Subjects who are on oral anticoagulant therapy (warfarin, dabigatran, and rivaroxaban).
• Known allergies to protein products (horse or bovine serum, or porcine trypsin) used in the cell production process.