Safety of Autologous Human Umbilical Cord Blood Treatment for Perinatal Arterial Ischemic Stroke

Autologous human umbilical cord blood (hUCB) stored at Cord Blood Registry will be given to
children who have suffered from a Perinatal Arterial Ischemic Stroke.

Subjects will come to Orlando for pretesting to include an MRI, SSEP, Urodynamics, blood
work: CBC, CMP, Hepatic Function Panel, PT/PTT/INR, Chest Xray, EEG, Gross Motor Function
Classification, Manual Ability Classification System, and a Speech and Language Evaluation.

After pretesting, the subjects will receive their autologous cord blood infusion
intravenously. The subjects will then be monitored for 24 hours post infusion. After 24
hours, the subject will undergo repeat blood work and a chest x ray. Subjects will then be
discharged home.

Subjects will follow up in Orlando at 6 months and 1 year post infusion. Follow up testing
will repeat the exams performed at pretesting.

Inclusion Criteria:

1. Between 6 weeks and 6 years of age on the day of study cord blood infusion.

2. MRI documented single arterial distribution infarction.

3. Initial injury occurring in the prenatal or perinatal period

4. Ability of child and caregiver to travel to Orlando, and stay for at least 4 days, and
to return for all Follow-up visits (patient is responsible for cost of travel and
lodging while in Orlando)

Exclusion Criteria:

1. Inability to obtain all pertinent medical records, including pertinent physician
notes, laboratory findings, and radiographic images, related to the original injury,
hospitalization and rehabilitation - must be sent to FHFC research team 14 days prior
to scheduled study cord blood treatment. Need brain MRI with flair sequence <2 weeks
old.

2. Recent radiographic evidence (imaging performed within past 2 weeks) of extensive
stroke as evidenced by >100ml lesion

3. Multifocal infarctions on screening MRI.

4. Evidence of hypoxic-ischemic encephalopathy on screening MRI.

5. Uncorrected coagulopathy during the baseline period defined as INR > 1.4; PTT> 35 sec;
PLT < 100,000

6. Known history of:

1. Recently diagnosed infection (within past 2 weeks) requiring treatment and/or
medical intervention

2. Renal disease or altered renal function as defined by serum creatinine >1.5 mg/dL
at admission

3. Hepatic disease or altered liver function as defined by SGPT > 150 U/L, and/or T.
Bilirubin >1.3 mg/dL at enrollment

4. Malignancy

5. Immunosuppression as defined by WBC < 3 (10x3) at admission

6. HIV

7. Any evidence of active maternal infection during the pregnancy (Hepatitis A, Hepatitis
B, Hepatitis C, HIV 1, HIV 2, Human T-lymphotropic Virus (HTLV) 1, HTLV 2

8. Pneumonia, or chronic lung disease requiring oxygen

9. Cord blood sample contamination

10. Participation in a concurrent intervention study

11. Desire for organ-donation in the event of death

12. Unwillingness or inability to stay for at least four days following cord blood
infusion (should any problems arise following the infusion) and to return for 6 month,
and 1 year follow-up visits