Safety of Autologous Stem Cell Treatment for Traumatic Brain Injury in Children

NCT00254722 | Completed Phase 1 DMC

• 2 other identifiers: HSC-MS-05-00041R21HD042659-01A1
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine if bone marrow progenitor cell (BMPC) autologous transplantation in children after isolated traumatic brain injury is safe and will improve functional outcome.

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury; Stem Cell

Outcome Measures

Primary Outcomes (3)

• neurologic events [seizures, change in Glasgow coma scale (GCS), cerebral vascular accident (CVA)]

  12 hours post cellular product infusion, up to 21 days post infusion

• infectious morbidity

  up to 21 days post cellular product infusion

• secondary organ injury

  up to 21 days post cellular product infusion

Study Arms (1)

I

EXPERIMENTAL

single arm study

Drug: Autologous bone marrow precursor cell harvest and transplant

Interventions

Autologous bone marrow precursor cell harvest and transplant DRUG

Bone marrow harvest (3 ml/kg of body weight) performed between 12 and 30 hours post injury, followed by single intravenous infusion of bone marrow progenitor cells - target dose is 6x10\^6 mononuclear cells/kg body weight, administered within 36 hours of injury

I

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Between 5 and 14 years of age on the day of injury
• Hospital admission Glasgow coma score between 5 and 8
• Initial injury occurring less than 24 hours prior to consent

You may not qualify if:

• Known history of:
• Previous brain injury
• Developmental delay
• Neurologic impairment and/or deficit
• Seizure disorder requiring anti-convulsant therapy
• Renal disease or altered renal function as defined by serum creatinine \> 1.5 mg/dL at admission
• Hepatic disease or altered liver function as defined by SGPT \> 150 U/L, and/or T. bilirubin \> 1.3 mg/dL at admission
• Cancer
• Immunosuppression as defined by WBC \< 3 (10x3) at admission
• HIV
• Obliteration of perimesencephalic cistern on initial head CT/MRI suggesting prolonged hypoxic ischemic insult
• Initial hospital ICP \> 40
• Hemodynamic instability at the time of consent defined as ongoing fluid resuscitation and/or requirement for inotropic support to maintain MAP at or above normals for age - does not include CPP based inotropic support
• Uncorrected coagulopathy at the time of consent defined as INR \> 1.4; PTT \> 35 sec; PLT \< 100,000; fibrinogen \< 100 g/dL
• Unstable pelvic fractures defined as requiring operative fixation to manage

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Transplantation

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Charles S. Cox, Jr., M.D.

  The University of Texas Health Science Center, 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: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 14, 2005
• First Posted: November 16, 2005
• Study Start: April 1, 2006
• Primary Completion: November 1, 2008
• Study Completion: October 1, 2009
• Last Updated: May 13, 2020

Record last verified: 2020-05