Treatment of Severe Adult Traumatic Brain Injury Using Bone Marrow Mononuclear Cells
2 other identifiers
interventional
25
1 country
1
Brief Summary
The purpose of this study is to determine if bone marrow harvest, BMMNC separation, and re-infusion in adults with acute severe TBI is safe and will improve functional outcome. 12/09/2015 Update: The study is closed to new enrollment and all follow-up visits have been completed. Data analysis is underway.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2012
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 6, 2012
CompletedFirst Posted
Study publicly available on registry
April 11, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJuly 13, 2016
July 1, 2016
3.2 years
April 6, 2012
July 11, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
neurological events (seizures, changes in Glasgow coma score [GCS], cerebral vascular accident [CVA})
12 hours post product infusion up to 21 days post infusion
Secondary Outcomes (3)
infectious morbidity
up to 21 days post infusion
global functional status per the GOS-E
up to 6 months post injury/treatment
global functioning per the Disability Rating Scale
up to 6 months post injury/treatment
Study Arms (1)
bone marrow mononuclear cells
EXPERIMENTALa bone marrow harvest will be performed within 36 hours of injury followed by a single intravenous infusion of autologous bone marrow mononuclear cells (BMMNCs)
Interventions
bone marrow harvest (5ml/kg of body weight) performed within 36 hours of injury, followed by single intravenous infusion of bone marrow mononuclear cells.
Eligibility Criteria
You may qualify if:
- Between 18 and 55 years of age on the day of injury;
- Hospital admission Glasgow Coma Score between 5 and 8;
- Initial injury occurring less than 24 hours prior to consent;
- Ability to speak English.
You may not qualify if:
- Known history of:
- brain injury,
- psychiatric disorder,
- neurological impairment and/or deficit
- seizure disorder requiring anti-convulsant therapy
- recently treated infection
- renal disease or altered renal function
- hepatic disease or altered liver function
- cancer
- substance abuse of positive urine drug screen at admission
- immunosuppression
- HIV
- Obliteration of perimesencephalic cistern on initial head CT suggesting prolonged hypoxic ischemic insult
- Initial hospital ICP \> 40mm Hg
- Hemodynamic instability at the time of consent defined as ongoing fluid resuscitation and/or requirement for inotropic support to maintain MAP at or above normals for age - does not include CPP based inotropic support
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Charles S Cox, Jr., M.D.
The University of Texas Health Science Center, Houston
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 6, 2012
First Posted
April 11, 2012
Study Start
March 1, 2012
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
July 13, 2016
Record last verified: 2016-07