Study of Human Placenta-derived Cells (PDA001) to Evaluate the Safety and Effectiveness for Patients With Ischemic Stroke

Inclusion Criteria

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

2. Subject or subject's legal representative must understand and voluntarily sign an
informed consent document prior to any study-related assessments/procedures being
conducted.

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

4. A female of childbearing potential (FCBP) must have a negative serum or urine
pregnancy test within 48 ± 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.

5. Diagnosis of stroke involving the middle cerebral artery (MCA) territory (cortical and
subcortical) or posterior cerebral artery (PCA) (PCA is limited to 3 subjects per
cohort) ischemic stroke confirmed by magnetic resonance imaging (MRI)/ computerized
tomography (CT). An ischemic stroke is death of an area of brain tissue (cerebral
infarction) resulting from an inadequate supply of blood and oxygen to the brain.

6. National Institute of Health Stroke Scale (NIHSS) score of ≥ 6 but < 20 at the time of
screening and infusion. Subject should not have shown rapid improvement (≥ 8 point
decrease) or deterioration (≥ 4 point increase) in the score from time of initial
evaluation to pre-infusion. To the extent possible, the time from initial screening
evaluation to reevaluation will be at least 24 hours.

7. Subject must have had a normal neurologic status prior to ischemic episode defined as
the absence of focal or global central neurological or psychiatric deficits of
sufficient magnitude that it could not reasonably be expected that the subject could
recover to the normal range based on the instruments used to assess the subject's
response to treatment. The pre-stroke modified Rankin score should be between 0 and 2
inclusive.

8. Treatment with tissue plasminogen activator (tPA) or Food and Drug Administration
(FDA)-approved devices used to restore circulation are allowed but treatment must be
completed at least 24 hours prior to administration of PDA001.

Exclusion Criteria

1. Any significant medical condition, laboratory abnormality, or psychiatric illness that
would prevent the subject or subject's legal representative from signing the informed
consent form.

2. Pregnant or lactating females.

3. Any condition, including any medical or neuropsychiatric condition, including the
presence of laboratory abnormalities, which in the judgment of the investigator places
the subject at unacceptable risk if he/she were to participate in the study or
confounds the ability to interpret data from the study including (but not limited to):

- Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT ) > 2.5 x the
upper limit of normal at screening.

- Serum creatinine concentration >1.5 times the upper limit of normal at screening.

- Bilirubin or alkaline phosphatase level > 2.5 x the upper limit of normal at
screening.

- Glucose < 50 mg/dL or > 250 mg/dL despite adequate antihyperglycemic treatment.

- Platelet count < 100 x 109 per liter.

- History of bacteremia or other serious bacterial or fungal infection requiring
treatment with IV antibiotics within 84 days (12 weeks) prior to treatment with
study therapy other than a treated urinary tract infection.

- Known infection with human immunodeficiency virus (HIV).

- Seropositive for hepatitis C or hepatitis B.

- Known history of seizures.

4. Severe heart failure or evidence of acute myocardial infarction defined of having at
least two of the following three features: (1) Chest pain suggestive of cardiac
ischemia; (2)Electrocardiogram (ECG) findings of ST elevation of greater than 0.2 mV
in 2 contiguous leads, new onset left bundle branch block, ST segment depression, or
T-wave inversion; (3) Elevated troponin I. History of prior myocardial infarction
within the previous 6 months.

5. Evidence of prior cerebral hemorrhage or ischemic stroke within the last 3 months or
recent intracerebral hematomas by head CT or MRI. This exclusion does not include
clinically insignificant petechial hemorrhages.

6. Subjects with only lacunar infarcts on MRI or CT. A lacunar infarct is defined as a
small (0.2 to 15 mm in diameter) noncortical infarct caused by occlusion of a single
penetrating branch of a large cerebral artery.

7. Persistent hypertension with systolic blood pressure (BP) greater than 185 mmHg or
diastolic BP greater than 110 mmHg (mean of 3 consecutive arm cuff readings over 20-30
minutes), not controlled by antihypertensive therapy or requiring nitroprusside for
control. Efforts should be made to bring systolic blood pressure (BP) to ≤ 160 or
diastolic BP ≤ 100 mmHg at the time of IP administration.

8. Clinically significant pulmonary dysfunction, including severe chronic obstructive
pulmonary disease (COPD) and history of lung resection.

9. High clinical suspicion of septic embolus.

10. History of pulmonary emboli or deep vein thrombus

11. History of major trauma at time of stroke

12. 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.

13. Known allergy to bovine or porcine products.

14. Known allergy to both gadolinium and iodine based contrast agents for MRI or CT scan
preventing the ability to conduct either one of these procedures.

15. Subject has received an investigational agent —an agent or device not approved by 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 trial prior to the completion of this study.