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Safety Study of Umbilical Cord Blood To Treat Pediatric Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01251003
Recruitment Status : Withdrawn (Unable to identify eligible subjects with traumatic brain injury who also have banked umbilical cord blood at CBR.)
First Posted : December 1, 2010
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
Charles Cox, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE November 29, 2010
First Posted Date  ICMJE December 1, 2010
Last Update Posted Date December 10, 2015
Study Start Date  ICMJE January 2011
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 30, 2010)
Determine if autologous hUCB transplantation is safe and free of infusion related toxicity. [ Time Frame: 0-21 days post cellular product infusion ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2010)
Determine if autologous hUCB transplantation improves post-TBI neuropsychological and imaging outcomes measures. [ Time Frame: 6 months, 12 months, 24 months post cellular product infusion ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety Study of Umbilical Cord Blood To Treat Pediatric Traumatic Brain Injury
Official Title  ICMJE Safety of Autologous Human Umbilical Cord Blood Treatment for Traumatic Brain in Children
Brief Summary The purpose of this study is to determine if it is safe to use stored autologous Human Umbilical Cord Blood (hUCB) to treat pediatric patients that sustain a severe or moderate Traumatic Brain Injury (TBI), and have not fully recovered as measured by the Glasgow Outcome Score-Expanded (GOS-EC)/Child at 6 to 18 months post-injury.
Detailed Description

Traumatic brain injury is the primary cause of pediatric trauma related morbidity and mortality. Currently there is no reparative therapeutic option available, and all interventions are designed to prevent injury progression or secondary brain injury. Pre-clinical data suggest that progenitor cellular infusions may reduce the severity of injury by a number of proposed mechanisms. The current study proposes a Phase 1 Safety Trial using stored autologous UCB to treat patients that sustain a severe or moderate TBI, and have not fully recovered as measured by the Glasgow Outcome Score-Expanded/Child at 6 to 18 months post-injury. We have chosen to use one bank that uses standardized processing and storage protocol to reduce cell product variability.

Families who have banked hUCB at Cord Blood Registry, Inc. (CBR), will be prospectively notified of the possibility of using their child's stored UCB if they sustain a moderate or severe TBI and have a persistent deficit at 6-18 months. Prior to enrolling in the study, patients will have their medical records, imaging studies reviewed, and a telephone interview will determine potential eligibility and exclusion criteria. If eligible, the patients will travel to Houston to undergo a medical history and physical exam, neuropsychiatric evaluation, DT-MRI imaging of the brain, and baseline laboratory evaluation. The UCB will be shipped to the Center for Cell and Gene Therapy for reanimation and characterization/determination of release criteria of the cell product (contamination-free). The UCB will be infused intravenously and the patient will be monitored as an in-patient in the Pediatric Intensive Care Unit (PICU) located within Children's Memorial Hermann Hospital for 24 hours, after which the patient will be discharged but will return the next day for a final examination. Follow-up visits will occur back at UT-Houston at 180 days, 1 year and 2 years post-infusion - these visits will include medical history and physical exam, neurological and neuropsych evaluations, and DT-MRI imaging of the brain.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Traumatic Brain Injury
Intervention  ICMJE Biological: Autologous cord blood
there is no minimum acceptable dose, and the maximum allowable dose will be 10x10(9)cells/kg given IV (in the vein), one time infusion
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 2, 2014)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2010)
10
Actual Study Completion Date  ICMJE May 2015
Estimated Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Hospital admission Glasgow Coma Score between 3 and 12 at the time of injury
  • Injury occurring 6 to 18 months prior to study cord blood infusion (+/- 30 days)
  • Ability of child and caregiver to travel to Houston, and stay for at least 4 days, and to return for all Follow-up visits
  • Ability of child to understand (and speak) English
  • Child's own cord blood banked at Cord Blood Registry

Exclusion Criteria:

  • Inability to obtain all pertinent medical records, including pertinent physician notes, laboratory findings, and radiographic images, related to the original injury, hospitalization and rehabilitation
  • Recent radiographic evidence of extensive stroke as evidenced by >100ml lesion
  • Pre-injury history of seizure disorder and/or neurological impairment
  • Obliteration of perimesencephalic cistern on initial head CT/MRI
  • Initial hospital Intracranial Pressure (ICP) > 40
  • Unhealed fractures or wounds including osteomyelitis
  • Pneumonia, or chronic lung disease requiring oxygen
  • Spinal cord injury as diagnosed by CT or MR imaging or by clinical findings
  • Cord blood sample contamination
  • Participation in a concurrent intervention study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Months to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01251003
Other Study ID Numbers  ICMJE HSC-MS-10-0061
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Charles Cox, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE Charles Cox
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Charles S Cox, Jr., MD University of Texas Medical School at Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date December 2015

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