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

This study has been withdrawn prior to enrollment.
(Unable to identify eligible subjects with traumatic brain injury who also have banked umbilical cord blood at CBR.)
Sponsor:
Information provided by (Responsible Party):
Charles Cox, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT01251003
First received: November 29, 2010
Last updated: May 2, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Traumatic Brain Injury
Biological: Autologous cord blood
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety of Autologous Human Umbilical Cord Blood Treatment for Traumatic Brain in Children

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Determine if autologous hUCB transplantation is safe and free of infusion related toxicity. [ Time Frame: 0-21 days post cellular product infusion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    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
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.

  Eligibility

Ages Eligible for Study:   18 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01251003

Locations
United States, Texas
The University of Texas Medical School at Houston, Children's Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Charles Cox
Investigators
Principal Investigator: Charles S Cox, Jr., MD University of Texas Medical School at Houston
  More Information

No publications provided

Responsible Party: Charles Cox, Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT01251003     History of Changes
Other Study ID Numbers: HSC-MS-10-0061
Study First Received: November 29, 2010
Last Updated: May 2, 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
Chronic

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 August 28, 2014