Umbilical Cord Blood in the Treatment of Stroke in Children. (Pedi Stroke)
The specific aims of this study are:
- To determine if Human Umbilical Cord Blood (hUCB) infusion is safe in children with perinatal arterial ischemic stroke (AIS).
- To determine if late functional outcome, physiologic response, and anatomic findings are changed following hUCB infusion in children with perinatal AIS.
|Arterial Ischemic Stroke (AIS) in Children||Biological: Autologous Human Cord Blood derived Stem Cell injection||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Safety of Autologous Human Umbilical Cord Blood in the Treatment of Stroke in Children.|
- Functional outcome measure [ Time Frame: Two years ]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.
- Speech Therapy Specific Neuropsychological outcome measures [ Time Frame: Two years ]Age appropriate Neurologic examinations and speech therapy specific standardized testing will be performed pre-treatment and at all follow-up visits.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||December 2016|
|Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
Experimental: Biologic; Cord Blood Stem Cells; Intravenous injection
Autologous Human Umbilical Cord Blood derived Stem Cell injection
Biological: Autologous Human Cord Blood derived Stem Cell injection
One time intravenous (in the vein) injection with two year follow-up
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 health.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01700166
|United States, Texas|
|Children's Memorial Hermann Hospital; University of Texas Health Science Center - Houston|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Timothy C. Foster, MD||The University of Texas Health Science Center, Houston|
|Principal Investigator:||Linda S. Baumgartner, MS, CCC-SLP, LSLS, Cert.AVT||Florida Hospital for Children - Orlando|
|Study Chair:||James E. Baumgartner, MD||Florida Hospital for Children - Orlando|