Pediatric Autologous Bone Marrow Mononuclear Cells for Severe Traumatic Brain Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by The University of Texas Health Science Center, Houston
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Charles Cox, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01851083
First received: May 5, 2013
Last updated: January 21, 2014
Last verified: January 2014

May 5, 2013
January 21, 2014
August 2013
June 2017   (final data collection date for primary outcome measure)
brain white matter and gray matter structural preservation on diffusion tensor magnetic resonance imaging (DTMRI) [ Time Frame: one year post infusion ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01851083 on ClinicalTrials.gov Archive Site
CNS white matter and gray matter preservation in regions of interest and improves functional and neurocognitive deficits in children after TBI [ Time Frame: one year post infusion ] [ Designated as safety issue: No ]
Same as current
Infusional toxicity safety evaluations [ Time Frame: 7 days post-infusion ] [ Designated as safety issue: Yes ]
Murray Score and liver function tests
Same as current
 
Pediatric Autologous Bone Marrow Mononuclear Cells for Severe Traumatic Brain Injury
Phase 2 Trial of Pediatric Autologous Bone Marrow Mononuclear Cells (BMMNCs) for Severe Traumatic Brain Injury (TBI)

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Traumatic Brain Injury
Biological: autologous bone marrow mononuclear cells
Other Name: BMMNCs
  • Experimental: autologous bone marrow mononuclear cells
    a bone marrow harvest will be performed within 36 hours of injury, followed by a single intravenous infusion of autologous bone marrow mononuclear cells
    Intervention: Biological: autologous bone marrow mononuclear cells
  • Placebo Comparator: placebo infusion
    a sham harvest will be performed within 36 hours of injury followed by a single intravenous placebo infusion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
June 2018
June 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Between 5 and 17 years of age on the day of injury
  • Hospital admission Glasgow Coma Score between 3 and 8
  • Initial injury occurring less than 24 hours prior to consent
  • Ability to speak English

Exclusion Criteria:

  • Known history of: previous brain injury; psychiatric disorder; neurologic 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; immunosuppression; HIV+; chemical or alcohol dependency; history of child abuse; premature birth.
  • Obliteration of perimesencephalic cistern on initial head CT/MRI suggesting prolonged hypoxic ischemic insult/herniation syndrome
  • Initial hospital Intracranial Pressure (ICP) > 40 mm Hg
  • Hemodynamic instability at the time of consent (24 hours post-injury)
  • Uncorrected coagulopathy at the time of bone marrow harvest
  • Unstable pelvic fractures defined as requiring early operative fixation to manage
  • Pulmonary contusions associated with the mechanism or injury
  • Greater than AAST Grade 3 solid or hollow visceral injury of the abdomen and/or pelvis
  • Spinal cord injury as diagnosed by imaging or by clinical findings
  • Persistent hypoxia
  • Positive urine pregnancy test
  • Participation in a concurrent intervention study
  • Unwillingness to return for follow-up visits
  • Contraindications to MRI
  • Penetrating brain injury
  • Unwillingness of parent or Legally Authorized Representative (LAR) to give written informed consent
Both
5 Years to 17 Years
No
Contact: Steven C Kosmach, MSN, RN, CCRC 713-500-7329 steven.kosmach@uth.tmc.edu
Contact: Fernando Jimenez, MS, RN 713-500-7395 fernando.jimenz@uth.tmc.edu
United States
 
NCT01851083
HSC-13-0038, R01NS077963
Yes
Charles Cox, The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Charles S Cox, Jr., M.D. The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP