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

Inclusion Criteria:

- Adult male or female subjects between 45 to 85 years of age (inclusive) at the time of
screening visit.

- Subjects with a 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).

- Subjects who have 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 Cilostazol free for at least 2 weeks
prior to the first ETT.

- Subjects should be receiving standard of care drugs for vascular disease including
anti-platelet agent(s) and statin medication, as well as anti-hypertensive
medication(s) and oral hypoglycemic agents/insulin, if indicated.

- Signed written informed consent.

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 (surgical or endovascular intervention) within 12 months
after screening.

- Lower extremity arteries inflow obstruction (defined as a greater than 50% stenosis of
aorta, iliac and/or common femoral arteries).

- History of Buerger's disease.

- Uncontrolled hypertension (defined as diastolic blood pressure > 100 mmHg or systolic
blood pressure > 180 mmHg during screening).

- Uncontrolled diabetes defined as glucose control HbA1c > 9% at screening.

- Life-threatening ventricular arrhythmia - except in subjects with an implantable
cardiac-defibrillator.

- Serum Creatinine level>2.5mg/dl.

- SGPT (ALT), SGOT (AST) >2.5 x upper limit of normal range.

- Hemoglobin < 10 g/dl.

- 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.

- Subjects with severe congestive heart failure symptoms (i.e. NYHA Stage III to IV).

- Subjects with Implant of mechanical prosthetic heart valve(s).

- Pulmonary disease requiring supplemental oxygen treatment on a daily basis.

- Severe, active infection of the involved extremity(ies), including osteomyelitis,
fasciitis, or severe/purulent cellulitis.

- History of malignancy within 5 years prior screening requiring chemotherapy and/or
radiotherapy and/or immunotherapy, excluding basal or squamous cell carcinoma of the
skin.

- Exercise is limited by any condition other than IC, including but not limited to
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, apixaban,
endoxaban and rivaroxaban). Unless, upon primary care physician and/or Investigator's
discretion the subjects who are on warfarin treatment can switch to Low Molecular
Weight Heparin treatment (such as: Clexane) 5-7 days prior study treatment
administration and return to warfarin treatment 24 hours post study treatment
administration.

- Subjects who are taking immunosuppressive treatment (including high dose steroids).

- Known allergies to protein products (Bovine serum, or recombinant trypsin) used in the
cell production process.

- Known sensitivity to Gentamycin.

- Known sensitivity to antihistamine drugs.

- History of hospitalization due to allergic/hypersensitivity reaction to any substance
(e.g. Food or drug).

- Medical history of Human Immunodeficiency Virus (HIV) or syphilis positivity at time
of screening.

- Known active Hepatitis B, or Hepatitis C infection at the time of screening.

- Pregnant or breast-feeding women or women of childbearing age not protected by an
effective contraceptive method of birth control (such as double barrier, oral or
parenteral hormonal, intrauterine device and spermicide).

- In the opinion of the Investigator, the subject is unsuitable for participating in the
study.

- Subject is currently enrolled in, or has not yet completed a period of at least 30
days since ending other investigational device or drug trial(s).

- Subjects that have prior exposure to gene or cell based therapy.

- Subjects who are legally detained in an official institute.