Traumatic Brain Injury
Conditions
Keywords
Umbilical Cord Blood, Allogeneic, Traumatic Brain Injury
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.
Interventions
BIOLOGICALAllogeneic Umbilical Cord Blood
Allogeneic Umbilical Cord Blood Transplantation via Intravenous or Intraarterial route
Sponsors
Bundang CHA Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in Short-term Memory Function | Baseline - 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 Global Outcome | 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 |
| Changes in Behavior | Baseline - 6 months |
Countries
South Korea
Outcome results
None listed