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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Functional outcome measure
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.
Timothy C. Foster, MD
The University of Texas Health Science Center, Houston
United States: Food and Drug Administration
JB IND #14576
|Children's Memorial Hermann Hospital; University of Texas Health Science Center - Houston||Houston, Texas 77030|