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Autologous Stem Cell Study for Adult TBI (Phase 2b)
Sponsor: The University of Texas Health Science Center, Houston
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.
Official title: A Multicenter Trial of Autologous Bone Marrow Mononuclear Cells for the Treatment of Adult Severe Traumatic Brain Injury
Key Details
Gender
All
Age Range
18 Years - 55 Years
Study Type
INTERVENTIONAL
Enrollment
37
Start Date
2016-11-21
Completion Date
2025-01
Last Updated
2024-05-09
Healthy Volunteers
No
Interventions
Placebo Infusion
In addition to the standard of care provided to all patients with traumatic brain injury, subjects assigned to the placebo control group will undergo a sham bone marrow harvest and receive a placebo infusion of saline.
Autologous BMMNC Infusion
In addition to the standard of care provided to all patients with traumatic brain injury, subjects assigned to the BMMNC treatment group will undergo a bone marrow harvest and then receive an autologous stem cell infusion.
Locations (1)
The University of Texas Health Science Center at Houston
Houston, Texas, United States