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Safety of Autologous Human Umbilical Cord Blood in the Treatment of Stroke in Children.

Phase 1
6 Weeks
6 Years
Open (Enrolling)
Arterial Ischemic Stroke (AIS) in Children

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Trial Information

Safety of Autologous Human Umbilical Cord Blood in the Treatment of Stroke in Children.

This study will enroll ten pediatric patients who have their umbilical cord blood banked
with Cord Blood Registry, Inc. (CBR), who have been diagnosed with an arterial ischemic
stroke (AIS), and whose caregivers contacted CBR, Inc. to notify them that the child has
experienced an AIS around the time of birth.

After receiving permission to release the patient's contact information, the CBR team will
then relay the contact information to the Stem Cell Study Group at the University of Texas -
Houston (UT) / Children's Memorial Hermann Hospital (CMHH) who will contact the family,
explain the study, and send a consent form for their review.

Several weeks prior to the scheduled procedure date, the patient will go to their family
doctor for a physical evaluation and have blood drawn to rule out problems with the child's

After successfully meeting initial pre-screening criteria, the patient's family will make
their own arrangements to travel to Houston for the study procedures.

Once the patient is in Houston, he/she will undergo baseline assessments, including
physical, neurological exams and tests, speech therapy testing, laboratory tests, and
imaging (MRI) of the brain. If any of the blood tests are abnormal, or the patient has an
active infection, the procedure may be postponed or the patient may possibly be excluded
from the study.

If the patient continues to meet all criteria, the frozen cord blood will be shipped
overnight to a special lab in Houston, TX for processing. Once release criteria have been
met, the cells will be brought to the CMHH for infusion into the patient's vein. The
patient will remain at CHMM for 24 hours of monitoring, after which they will be allowed to
go home. Patients will be called daily by the research staff through Day 14, and once a
month after that.

Patients will return to Houston, Texas for 6 month, 1 year and 2 year follow-up visits for
repeat assessments, tests, and exams just like at the baseline visit. The MRI of the brain
will only be repeated at the 6 month visit.

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 pre-natal or perinatal period.

4. Ability of caregivers to understand and speak English

5. Ability of child and caregiver to travel to Houston, 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 Houston)

Exclusion Criteria:

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 research team at least 14 days prior
to scheduled study cord blood treatment.

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

2. Multifocal infarctions on screening MRI.

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

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

5. 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, Hepatitis B, Hepatitis C.

6. Pneumonia, or chronic lung disease requiring oxygen.

7. Cord blood sample contamination.

8. Participation in a concurrent intervention study.

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

10. 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, 1 year, and 2 year follow-up visits.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Functional outcome measure

Outcome Description:

Physiological (e.g., SSEP, EEG) and anatomic outcome (MRI) changes will be evaluated by repeating assessments, clinical tests and imaging exams at the pre-treatment and follow-up visits.

Outcome Time Frame:

Two years

Safety Issue:


Principal Investigator

Timothy C. Foster, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Texas Health Science Center, Houston


United States: Food and Drug Administration

Study ID:

JB IND #14576



Start Date:

September 2012

Completion Date:

December 2015

Related Keywords:

  • Arterial Ischemic Stroke (AIS) in Children
  • Autologous
  • Cord Blood
  • Stem Cells
  • Pediatric stroke
  • Children with ischemic stroke
  • Cerebral Palsy
  • Perinatal AIS
  • Ischemia
  • Stroke
  • Cerebral Infarction



Children's Memorial Hermann Hospital; University of Texas Health Science Center - Houston Houston, Texas  77030