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NCT02525432 · ClinicalTrials.gov registry record · Phase 2
Autologous Stem Cell Study for Adult TBI (Phase 2b)
A Phase 2 study of Brain Injuries, Traumatic and TBI (Traumatic Brain Injury), sponsored by The University of Texas Health Science Center, Houston.
- Active
- Registry status
- Phase 2
- Development phase
- 37
- Enrollment target
- 1
- Study location
NCT02525432: Active Phase 2 study of Brain Injuries, Traumatic and TBI (Traumatic Brain Injury), sponsored by The University of Texas Health Science Center, Houston.
NCT02525432 is a Phase 2 study of Brain Injuries, Traumatic and TBI (Traumatic Brain Injury) that is active but no longer recruiting, run by The University of Texas Health Science Center, Houston. The registered enrollment target is 37 participants, below the 254-participant average among 21 other Brain Injuries, Traumatic trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02525432, a Phase 2 study of Brain Injuries, Traumatic and TBI (Traumatic Brain Injury), is active but no longer recruiting, sponsored by The University of Texas Health Science Center, Houston.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 37 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to determine the effect of intravenous infusion of autologous bone marrow mononuclear cells (BMMNC) on brain structure and neurocognitive/functional outcomes after severe traumatic brain (TBI) injury in adults. The primary objective is to determine if the intravenous infusion of autologous BMMNC after severe TBI results in structural preservation of global gray matter (GM) volume and white matter (WM) volume and integrity; as well as select regions of interest in the corpus callosum. THe secondary objectives are to determine if autologous BMMNC infusion improves functional and neurocognitive deficits in adults after TBI; reduces the neuroinflammatory response to TBI; evaluate spleen size and splenic blood flow over time using ultrasound and corresponding changes in inflammatory cytokines; and infusion related toxicity and long-term follow-up safety evaluations.
Conditions Studied
Interventions
- BIOLOGICAL Placebo Infusion
- BIOLOGICAL Autologous BMMNC Infusion
Study Locations (1)
Texas
- The University of Texas Health Science Center at Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2016-11-21 |
| Est. Completion | 2025-01 |
| Phase | Phase 2 |
What the registry record for NCT02525432 still lists
NCT02525432 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 254-participant average among 21 other Brain Injuries, Traumatic trials with a reported enrollment target (85% lower).
The record links to 3 conditions, with Brain Injuries, Traumatic appearing as the primary indexed condition, and to 2 interventions - of which Placebo Infusion is the first listed.
NCT02525432 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02525432 about?
NCT02525432 is a clinical study titled "Autologous Stem Cell Study for Adult TBI (Phase 2b)". The purpose of this study is to determine the effect of intravenous infusion of autologous bone marrow mononuclear cells (BMMNC) on brain structure and neurocognitive/functional outcomes after severe traumatic brain (TBI) injury in adults. The primary objective is to determine if the intravenous inf...
What is the current status of trial NCT02525432?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 37 participants. The study started on 2016-11-21. Estimated completion is 2025-01.
What conditions does trial NCT02525432 study?
This clinical trial studies the following conditions: Brain Injuries, Traumatic, TBI (Traumatic Brain Injury), Brain Injuries, Acute.
What interventions are being tested in trial NCT02525432?
The interventions under investigation include: Placebo Infusion (BIOLOGICAL), Autologous BMMNC Infusion (BIOLOGICAL).
Who is sponsoring clinical trial NCT02525432?
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 NCT02525432 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02525432's enrollment target sits among peer trials
37 18th of 21 higher than 4 of 21 other Brain Injuries, Traumatic trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Injuries, Traumatic 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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