The Efficacy and Safety of Allogeneic Umbilical Cord Blood Therapy for Chronic Traumatic Brain Injury Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Traumatic Brain Injury
- Sponsor
- Bundang CHA Hospital
- Locations
- 1
- Primary Endpoint
- Changes in Short-term Memory Function
- Status
- Withdrawn
- Last Updated
- 12 years ago
Overview
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.
Investigators
MinYoung Kim, M.D.
Associate Professor
Bundang CHA Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
Changes in Short-term Memory Function
Time Frame: Baseline - 6 months
Secondary Outcomes
- Changes in Emotion and Personality(Baseline - 6 months)
- Changes in Behavior(Baseline - 6 months)
- Changes in Global Outcome(Baseline - 6 months)
- Changes in Intelligence(Baseline - 6 months)
- Changes in Frontal Lobe Function(Baseline - 6 months)
- Changes in Attention(Baseline - 6 months)
- Changes in Traumatic Brain Injury-related Symptoms(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)