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

NCT01251003 | Withdrawn Phase 1 DMC

• 1 other identifier: HSC-MS-10-0061
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury; TBI; Pediatric; Chronic

Outcome Measures

Primary Outcomes (1)

• Determine if autologous hUCB transplantation is safe and free of infusion related toxicity.

  0-21 days post cellular product infusion

Secondary Outcomes (1)

• Determine if autologous hUCB transplantation improves post-TBI neuropsychological and imaging outcomes measures.

  6 months, 12 months, 24 months post cellular product infusion

Interventions

Autologous cord blood BIOLOGICAL

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

Eligibility Criteria

• Age: 18 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles Cox: lead

Study Sites (1)

The University of Texas Medical School at Houston, Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Study Officials

• Charles S Cox, Jr., MD

  University of Texas Medical School at Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 29, 2010
• First Posted: December 1, 2010
• Study Start: January 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: May 1, 2015
• Last Updated: December 10, 2015

Record last verified: 2015-12

Locations

US (1)