Study of Human Placenta-derived Cells (PDA002) to Evaluate the Safety and Effectiveness in Subjects With PAD and DFU

Inclusion Criteria:

   - Subjects must satisfy the following criteria to be enrolled in the study:

      1. Males and females, 18 to 80 years of age at the time of signing the informed
      consent document.

      2. Understand and voluntarily sign an informed consent document prior to any study
      related assessments/procedures are conducted.

      3. Able to adhere to the study visit schedule and other protocol requirements.

      4. Diabetes mellitus type 2

      5. Ischemic or neuro-ischemic diabetic foot ulcer with severity of Grade 1 (full
      thickness only) or Grade 2 on the Wagner Grading Scale (Appendix A) of greater
      than one month duration which has not adequately responded to conventional ulcer
      therapy.

      6. Peripheral arterial disease with ankle-brachial index > 0.6 and ≤ 0.9 or
      toe-brachial index > 0.35 and ≤ 0.7.

      7. No planned revascularization or amputation over the next 3 months after Screening
      visit, in the opinion of the Investigator.

      8. Not a candidate for peripheral artery percutaneous or surgical revascularization.

      9. Screening should not begin until at least 2 weeks after a failed reperfusion
      intervention and at least 2 months after a successful mechanical intervention.

   10. Subject can have stable angina, (Canadian Cardiovascular Society (CCS) Class I-II
      angina (Appendix H).

   11. Subjects should be receiving appropriate medical therapy for hypertension and
      diabetes.

   12. Subject must be a non-tobacco user defined as someone who has not used
      tobacco/nicotine patch for ≥ 3 months and must agree to remain tobacco/nicotine
      free for the duration of the study.

   13. A female of childbearing potential [FCBP] must have a negative serum pregnancy
      test at Screening and a negative urine pregnancy test prior to treatment with
      study therapy. In addition, sexually active FCBP must agree to use 2 of the
      following adequate forms of contraception methods simultaneously such as: oral,
      injectable, or implantable hormonal contraception; tubal ligation; intrauterine
      device [IUD]; barrier contraceptive with spermicide or vasectomized partner for
      the duration of the study and the follow-up period.

   14. Males (including those who have had a vasectomy) must agree to use barrier
      contraception (latex condoms) when engaging in reproductive sexual activity with
      FCBP for the duration of the study and the follow-up period.

      Exclusion Criteria:

   - The presence of any of the following will exclude a subject from enrollment:

      1. Any significant medical condition, laboratory abnormality, or psychiatric illness
      that would prevent the subject from participating in the study.

      2. Any condition including the presence of laboratory abnormalities, which places
      the subject at unacceptable risk if he or she were to participate in the study.

      3. Any condition that confounds the ability to interpret data from the study.

      4. Subjects whom, in the judgment of the Investigator, are at elevated risk for the
      development of a malignancy. This judgment may be based on family history,
      history of industrial exposures, smoking history or other cancer risk factors.

      5. Known to be positive for human immunodeficiency virus.

      6. Pregnant or lactating females.

      7. Subjects with a body mass index > 35 at Screening.

      8. Aspartate transaminase (AST) or Alanine transaminase (ALT) > 2.5 x the upper
      limit of normal (ULN) at Screening.

      9. Estimated Glomerular Filtration Rate (eGFR) < 45 mL/min/1.73 m2 at Screening
      calculated using the Modification of Diet in Renal Disease Study equation (Levey,
      2006) or history of eGFR decline > 15 mL/min/1.73 m2 in the past year.

   10. Alkaline phosphatase > 2.5 x the ULN at Screening.

   11. Bilirubin level > 2 mg/dL (unless subject has known Gilbert's disease) at
      Screening.

   12. Untreated chronic infection or treatment of any infection with systemic
      antibiotics, including the ulcer site, within 4 weeks prior to dosing with
      investigational product [IP].

   13. Known osteomyelitis.

   14. History of Methicillin-resistant Staphylococcus aureus (MRSA).

   15. Ulcer that has decreased or increased in size by ≥ 50% during the screening
      period.

   16. Uncontrolled hypertension (defined as diastolic blood pressure > 100 mmHg or
      systolic blood pressure > 180 mmHg during Screening at 2 independent measurements
      taken while subject is sitting and resting for at least 5 minutes).

   17. Poorly controlled diabetes mellitus (hemoglobin A1c > 9%).

   18. Untreated proliferative retinopathy.

   19. History of malignant ventricular arrhythmia, CCS Class III-IV angina pectoris,
      myocardial infarction/PCI (percutaneous coronary intervention)/CABG (coronary
      artery bypass graft) in the preceding 6 months, pending coronary
      revascularization in the following 2 months, transient ischemic
      attack/cerebrovascular accident in the preceding 6 months, and/or New York Heart
      Association [NYHA] Stage III or IV congestive heart failure, (Appendix C).

   20. Abnormal ECG: new bundle branch block (BBB) ≥ 120 msec in the preceding 3 months;
      QTcB and/or QTcF > 480 msec or QTcB and/or QTcF ≥ 500 msec with old BBB. Patients
      with a potential risk for Torsades des Pointes should not be enrolled.

   21. Uncontrolled hypercoagulation.

   22. Life expectancy less than 2 years due to concomitant illnesses.

   23. In the opinion of the Investigator, the subject is unsuitable for cellular
      therapy.

   24. History of malignancy within 5 years except basal cell or squamous cell carcinoma
      of the skin or remote history of cancer now considered cured or positive Pap
      smear with subsequent negative follow-up.

   25. History of hypersensitivity to any of the components of the product formulation
      (including bovine or porcine products, dextran 40, and dimethyl sulfoxide
      [DMSO]).

   26. Disorders or allergies precluding the use of radiographic contrast or renal
      insufficiency severe enough to contraindicate the use of radiographic contrast.

   27. Subject has received an investigational agent -an agent or device not approved by
      the US Food and Drug Administration (FDA) for marketed use in any indication-
      within 90 days (or 5 half-lives, whichever is longer) prior to treatment with
      study therapy or planned participation in another therapeutic study prior to the
      completion of this study.

   28. Subject has received previous gene or cell therapy.