Allogeneic Umbilical Cord Blood Therapy for Chronic TBI

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Efficacy and Safety of Allogeneic Umbilical Cord Blood Therapy for Chronic Traumatic Brain Injury Patients

Conditions
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Traumatic Brain Injury

Intervention / Treatment
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* Biological: Allogeneic Umbilical Cord Blood


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Allogeneic Umbilical Cord Blood<br>Allogeneic Umbilical Cord Blood Transplantation | Biological: Allogeneic Umbilical Cord Blood<br>* Allogeneic Umbilical Cord Blood Transplantation via Intravenous or Intraarterial route<br>* Other names: Umbilical Cord Blood;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Short-term Memory Function |  | Baseline - 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Umbilical Cord Blood, Allogeneic, Traumatic Brain Injury