Allogeneic Umbilical Cord Blood Therapy for Chronic TBI

Not Applicable

Withdrawn

• Conditions: Traumatic Brain Injury
• Interventions: Biological: Allogeneic Umbilical Cord Blood

• Registration Number: NCT01451528
• Lead Sponsor: Bundang CHA Hospital

Brief Summary

This open label trial is conducted to investigate the efficacy and safety of umbilical cord blood therapy for chronic traumatic brain injury patients.

The study hypothesis is that the participants will show significant improvement in cognition and function after Umbilical cord blood (UCB) transplantation.

Detailed Description

Traumatic brain injury patients have been increasing due to various accidents. After acute therapeutic intervention, rehabilitation is the conventional main treatment with medication. However, in chronic stage, there seems to be some limitation in obtaining functional improvement in spite of comprehensive rehabilitation. Cell therapy like Umbilical cord blood (UCB) transplantation has showed promising results in many animal studies. The mechanism of such neurological improvement is not fully understood. Stem cells included in UCB are expected to secrete neurotrophic factors to enhance brain function. In addition, anti-inflammatory effects of UCB are suggested. Autologous UCB are not available in most of the cases in fact. The aim of this clinical trial is to determine the safety and efficacy of allogeneic UCB.

Study Timeline

• Study First Submitted: 2011-10-11
• Study First Submitted QC: 2011-10-11
• Study First Posted: 2011-10-13
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-02
• Last Update Posted: 2014-04-03
• Study Start: 2014-07
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Chronic Traumatic Brain Injury Patient (onset duration: over 6 months)
• Glasgow Outcome Scale: 2, 3, 4, 5

Exclusion Criteria

• High risk of pneumonia or renal function deterioration after immunosuppressant
• Possibility of drug hypersensitivity which is related to this study remedy
• Intractable seizure disorder
• Poor cooperation of guardian,including inactive attitude for rehabilitation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Allogeneic Umbilical Cord Blood	Allogeneic Umbilical Cord Blood	Allogeneic Umbilical Cord Blood Transplantation

Primary Outcome Measures

Name	Time	Method
Changes in Short-term Memory Function	Baseline - 6 months

Secondary Outcome Measures

Name	Time	Method
Changes in Global Outcome	Baseline - 6 months
Changes in Intelligence	Baseline - 6 months
Changes in Frontal Lobe Function	Baseline - 6 months
Changes in Traumatic Brain Injury-related Symptoms	Baseline - 6 months
Changes in Attention	Baseline - 6 months
Changes in Behavior	Baseline - 6 months
Changes in Emotion and Personality	Baseline - 6 months
Changes in Motor Function and Activities of Daily Living	Baseline - 6 months
Changes in Brain Structure	Baseline - 6 months
Changes in Brain Glucose Metabolism	Baseline - 2 weeks

Trial Locations

Locations (1)

CHA Bundang Medical Center, CHA University; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of