Safety of Intravenous Infusion of Human Placenta-Derived Cells (PDA001) for the Treatment of Adults With Stage II or III Pulmonary Sarcoidosis

Inclusion Criteria:

1. Male or female subjects 18 years to 75 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. Must be able to adhere to the study visit schedule and other protocol requirements

4. Weight must be ≥ 50 kg

5. A female of childbearing potential (FCBP) must have a negative serum or urine
pregnancy test within 24 hours prior to treatment with study therapy. In addition,
sexually active FCBP must agree to use two of the following adequate forms of
contraception methods simultaneously such as: oral, injectable or implantable hormonal
contraception; tubal ligation; intrauterine device; barrier contraceptive with
spermicide; or vasectomized partner for the duration of the study and the follow-up
period. 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

6. Diagnosis of sarcoidosis as evidenced by parenchymal disease on chest radiograph
(Stage II or III), as well as histologic confirmation of granulomatous inflammation
and disease duration of ≥ 1 year

7. Refractory to one or more of the following; methotrexate, immunosuppressants or
cytotoxic agents

8. Forced vital capacity (FVC) of ≥ 45% and ≤ 80% of predicted normal value at screening

9. Must be on a stable dose of prednisone, methotrexate, and/or azathioprine for
pulmonary Sarcoidosis for 4 weeks prior to infusion of the IP

Exclusion Criteria:

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

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

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

4. Subjects with Stage I or Stage IV sarcoidosis

5. Subjects with cutaneous sarcoidosis only

6. Subjects with neurosarcoidosis or (clinically apparent) cardiac sarcoidosis

7. Lung disease, other than sarcoid related, such as asthma, chronic obstructive
pulmonary disease (COPD), interstitial lung disease (ILD)

8. History of listeriosis, coccidiomycosis, histoplasmosis, blastomycosis, treated or
untreated tuberculosis or exposure to individuals with tuberculosis

9. History of pulmonary emboli or deep vein thrombus

10. Active smoker or previous smoker > 10 pack years (PY). Previous smokers must have
discontinued smoking for at least 1 year

11. Morbidly obese [Body Mass Index (BMI)] > 35 at screening)

12. Inability to perform 6 Minute Walk Test (6MWT) or Pulmonary Function Test (PFT)
maneuvers

13. Sickle cell disease (Hemoglobin SS, Hemoglobin SC, and sickle cell-beta thalassemia)

14. Treatment at any time with B cell depleting therapies

15. Any biologic anti-tumor necrosis factor (anti-TNF) therapy within the previous year

16. Active infection requiring treatment within 30 days prior to screening

17. Pregnant or lactating females

18. Aspartate transaminase (AST), alanine aminotransferase (ALT) or creatine phosphokinase
(CPK) > 2 x the upper limit of normal at screening

19. Active infection with hepatitis B or hepatitis C

20. Known infection with human immunodeficiency virus (HIV)

21. Creatinine level > 1.5 times the upper limit of normal

22. Platelet count < 100,000/µL (< 100 x 109/L)

23. White blood cell count < 3,000/cu mm (< 3.0 x 109/L) or >20,000/cu mm (> 20 x 109/L)

24. Organic heart disease (e.g., congestive heart failure, cor pulmonale), myocardial
infarction within six months prior to screening

25. Clinically significant findings on electrocardiogram (ECG) at screening (eg,
arrhythmia)

26. History of other malignancies within 5 years (except basal cell carcinoma of the skin
that is surgically cured, remote history of cancer now considered cured or positive
Pap smear with subsequent negative follow-up)

27. Documented prior history of neurological disease or evidence of ongoing neurological
disease

28. Known allergy to bovine or porcine products

29. Subject has received an investigational agent (an agent or device not approved by
Federal Drug Administration (FDA) for marketed use in any indication) within 90 days
(or 5 half-lives, whichever is longer) prior to treatment with investigational product
(IP)

30. Subject who has received previous cell therapy

31. Subject is expecting to have elective surgery within 12 weeks prior to or post dosing
with IP if the surgery would be expected to confound evaluation of outcome endpoints