Pediatric Autologous Bone Marrow Mononuclear Cells for Severe Traumatic Brain Injury

This study is currently recruiting participants.
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
  Purpose

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.


Condition Intervention Phase
Traumatic Brain Injury
Biological: autologous bone marrow mononuclear cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Trial of Pediatric Autologous Bone Marrow Mononuclear Cells (BMMNCs) for Severe Traumatic Brain Injury (TBI)

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • Infusional toxicity safety evaluations [ Time Frame: 7 days post-infusion ] [ Designated as safety issue: Yes ]
    Murray Score and liver function tests


Estimated Enrollment: 50
Study Start Date: August 2013
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Biological: autologous bone marrow mononuclear cells
Other Name: BMMNCs
Placebo Comparator: placebo infusion
a sham harvest will be performed within 36 hours of injury followed by a single intravenous placebo infusion

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01851083

Contacts
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

Locations
United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Steven C Kosmach, MSN, RN, CCRC    713-500-7329    steven.kosmach@uth.tmc.edu   
Contact: Charles S Cox, Jr., M.D.       charles.s.cox@uth.tmc.edu   
Principal Investigator: Charles S. Cox, Jr., M.D.         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Charles S Cox, Jr., M.D. The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: Charles Cox, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01851083     History of Changes
Other Study ID Numbers: HSC-13-0038, R01NS077963
Study First Received: May 5, 2013
Last Updated: January 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas Health Science Center, Houston:
Traumatic Brain Injury
TBI
pediatric
acute
stem cells

Additional relevant MeSH terms:
Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 20, 2014