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Sponsored by: |
The University of Texas Health Science Center, Houston |
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Information provided by: | The University of Texas Health Science Center, Houston |
ClinicalTrials.gov Identifier: | NCT00254722 |
The purpose of this study is to determine if bone marrow progenitor cell (BMPC) autologous transplantation in children after isolated traumatic brain injury is safe and will improve functional outcome.
Condition | Intervention | Phase |
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Traumatic Brain Injury |
Procedure: Autologous bone marrow precursor cell harvest and transplant |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety Study |
Official Title: | Safety of Autologous Stem Cell Treatment for Traumatic Brain Injury in Children |
Estimated Enrollment: | 10 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | December 2009 |
Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: Experimental
single arm study
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Procedure: Autologous bone marrow precursor cell harvest and transplant
Bone marrow harvest (3 ml/kg of body weight) performed between 12 and 30 hours post injury, followed by single intravenous infusion of bone marrow progenitor cells - target dose is 6x10^6 mononuclear cells/kg body weight, administered within 36 hours of injury
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Traumatic brain injury (TBI) contributes to 50% of all trauma deaths. The mortality rate for children following severe TBI (Glasgow Coma Scale < 9) ranges from 14-24%. There is currently no therapy to reverse the primary injury associated with TBI. Bone marrow precursor cells (BMPC) or bone marrow mononuclear cellular fractions of bone marrow contain mesenchymal stem cells (MSC) and hematopoetic stem cells (HSC). These cells are a component of bone marrow that preferentially migrate to the site of brain injury and differentiate into neurons and cell supporting elements, improving functional outcome in animals. The primary objective of this study is to determine if BMPC harvest and autologous transplantation is safe in children after TBI. The secondary objective is to determine if late functional outcome is improved with BMPC autologous transplantation compared to age and severity matched concomitant controls. Safety will be determined by monitoring cerebral and systemic hemodynamics during harvest and transplantation, neurologic events (seizure, change in GCS, stroke), local site inflammation/injury, and secondary organ injury. Late outcomes will be determined using age-corrected Glasgow Outcome Scores, and a battery of functional outcome measures. In vitro, an aliquot of cells harvested from patients will be studied for labeling with magnetodendrimers as a feasibility study, and these cells will not be reinfused into the patients. The primary endpoint is to assess the safety of autologous BMPC harvest/transplantation in the acute injury phase (hospital stay) and the secondary endpoint is to assess efficacy through 1 and 6 month post-injury follow-up. The rationale for the use of autologous BMPC transplantation is based on a large volume of in vitro and in vivo animal data (see background and significance section). The rationale for using children as the primary population is that children have a greater neurologic plasticity with a unique injury pattern when compared to adults. Children are more likely to have isolated TBI that is more diffuse and less likely to be secondary to extra-axial fluid collections. Patients aged 5-14 years old with GCS of 5-8 will be considered for enrollment into the study. Within 24-36 hours of injury, enrolled patients will undergo bone marrow harvest/BMPC separation and re-infusion. Daily monitoring of the safety outcomes measures and long term neurologic outcomes will be performed. This study should determine if bone marrow harvest, BMPC separation, and reinfusion is safe in children after severe TBI.
Ages Eligible for Study: | 5 Years to 14 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Known history of:
United States, Texas | |
UT-Houston Pediatric Surgery & Memorial Hermann Children's Hospital | |
Houston, Texas, United States, 77030 |
Principal Investigator: | Charles S. Cox, Jr., M.D. | The University of Texas Health Science Center, Houston |
Responsible Party: | University of Texas Medical School at Houston ( Charles S. Cox, Jr. M.D. ) |
Study ID Numbers: | HSC-MS-05-0004, 1R21HD042659-01A1 |
Study First Received: | November 14, 2005 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00254722 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Traumatic Brain Injury Stem Cell |
Craniocerebral Trauma Wounds and Injuries Disorders of Environmental Origin Central Nervous System Diseases |
Trauma, Nervous System Brain Diseases Brain Injuries |
Craniocerebral Trauma Nervous System Diseases Wounds and Injuries Disorders of Environmental Origin |
Central Nervous System Diseases Trauma, Nervous System Brain Diseases Brain Injuries |