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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-141 | Other Identifier | IRB of CHA Bundang Medical Center |
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The research fund, which is yet to be raised and expected to take for a while
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allogeneic Umbilical Cord Blood | Experimental | Allogeneic Umbilical Cord Blood Transplantation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic Umbilical Cord Blood | Biological | Allogeneic Umbilical Cord Blood Transplantation via Intravenous or Intraarterial route |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in Short-term Memory Function | Baseline - 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Global Outcome | Baseline - 6 months | |
| Changes in Intelligence | Baseline - 6 months | |
| Changes in Frontal Lobe Function |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Minyoung Kim, M.D., Ph.D. | CHA University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHA Bundang Medical Center, CHA University | Seongnam-si | Gyeonggi-do | 463-712 | South Korea |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| 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 |
| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |