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ACTIVE NOT RECRUITING
NCT02525432
PHASE2

Autologous Stem Cell Study for Adult TBI (Phase 2b)

Sponsor: The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

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

BIOLOGICAL

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.

BIOLOGICAL

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