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NCT01851083 · ClinicalTrials.gov registry record · Phase 2
Pediatric Autologous Bone Marrow Mononuclear Cells for Severe Traumatic Brain Injury
A Phase 2 study of Traumatic Brain Injury, sponsored by The University of Texas Health Science Center, Houston.
- Completed
- Registry status
- Phase 2
- Development phase
- 47
- Enrollment target
- 2
- Study locations
NCT01851083: Completed Phase 2 study of Traumatic Brain Injury, sponsored by The University of Texas Health Science Center, Houston.
NCT01851083 is a Phase 2 study of Traumatic Brain Injury that has completed, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 47 participants, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (83% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01851083, a Phase 2 study of Traumatic Brain Injury, has completed, sponsored by The University of Texas Health Science Center, Houston.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 47 participants
- Enrollment target
- 2
- Study locations
Study Summary
Pediatric severe traumatic brain injury (TBI) is the leading cause of death and disability in children ages 1-14 years old. There are no effective therapies to treat secondary brain injury and the post-injury response of CNS apoptosis and neuroinflammation. This study is a follow-up trial from a previously performed Phase I trial that demonstrated the safety and potential CNS structural preservation effect of intravenous autologous bone marrow mononuclear cells (BMMNC) after severe TBI in children. (Cox, 2011) The study is designed as a prospective, randomized, placebo controlled, blinded Phase 2 safety/biological activity study. The investigators hope to determine the effect of intravenous infusion of autologous BMMNCs on brain structure and neurocognitive/functional outcomes after severe TBI in children.
Primary Outcome
DTMRI quantitative indices of both macro and microscopic integrity will be evaluated and compared to DTMRI of immediate post-injury treated and non-treated controls.
Conditions Studied
Interventions
- OTHER Placebo Infusion
- BIOLOGICAL autologous bone marrow mononuclear cells
Study Locations (2)
Arizona
- Phoenix Children's Hospital I University of Arizona - Phoenix
Texas
- The University of Texas Health Science Center at Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2013-08 |
| Est. Completion | 2020-10-12 |
| Phase | Phase 2 |
What the finished NCT01851083 record still lists
NCT01851083 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 277-participant average among 171 other Traumatic Brain Injury trials with a reported enrollment target (83% lower).
The record links to 1 condition, with Traumatic Brain Injury appearing as the primary indexed condition, and to 2 interventions - of which Placebo Infusion is the first listed.
NCT01851083 reports a single indexed study location in Arizona, Texas.
Frequently Asked Questions
What is clinical trial NCT01851083 about?
NCT01851083 is a clinical study titled "Pediatric Autologous Bone Marrow Mononuclear Cells for Severe Traumatic Brain Injury". Pediatric severe traumatic brain injury (TBI) is the leading cause of death and disability in children ages 1-14 years old. There are no effective therapies to treat secondary brain injury and the post-injury response of CNS apoptosis and neuroinflammation. This study is a follow-up trial from a pre...
What is the current status of trial NCT01851083?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 47 participants. The study started on 2013-08. Estimated completion is 2020-10-12.
What conditions does trial NCT01851083 study?
This clinical trial studies the following conditions: Traumatic Brain Injury.
What interventions are being tested in trial NCT01851083?
The interventions under investigation include: Placebo Infusion (OTHER), autologous bone marrow mononuclear cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT01851083?
This trial is sponsored by The University of Texas Health Science Center, Houston, which has 732 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01851083 being conducted?
This trial has 2 study locations across Arizona, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Traumatic Brain Injury
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01851083's enrollment target sits among peer trials
47 123rd of 171 higher than 49 of 171 other Traumatic Brain Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Traumatic Brain Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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