Allogeneic Umbilical Cord Blood Therapy for Chronic TBI
This study is not yet open for participant recruitment.
Verified July 2012 by Bundang CHA Hospital
Sponsor:
Bundang CHA Hospital
Information provided by (Responsible Party):
MinYoung Kim, M.D., Bundang CHA Hospital
ClinicalTrials.gov Identifier:
NCT01451528
First received: October 11, 2011
Last updated: December 14, 2012
Last verified: July 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Traumatic Brain Injury |
Biological: Allogeneic Umbilical Cord Blood |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | The Efficacy and Safety of Allogeneic Umbilical Cord Blood Therapy for Chronic Traumatic Brain Injury Patients |
Resource links provided by NLM:
Further study details as provided by Bundang CHA Hospital:
Primary Outcome Measures:
- Changes in Short-term Memory Function [ Time Frame: Baseline - 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Changes in Global Outcome [ Time Frame: Baseline - 6 months ] [ Designated as safety issue: No ]
- Changes in Intelligence [ Time Frame: Baseline - 6 months ] [ Designated as safety issue: No ]
- Changes in Frontal Lobe Function [ Time Frame: Baseline - 6 months ] [ Designated as safety issue: No ]
- Changes in Traumatic Brain Injury-related Symptoms [ Time Frame: Baseline - 6 months ] [ Designated as safety issue: No ]
- Changes in Attention [ Time Frame: Baseline - 6 months ] [ Designated as safety issue: No ]
- Changes in Behavior [ Time Frame: Baseline - 6 months ] [ Designated as safety issue: No ]
- Changes in Emotion and Personality [ Time Frame: Baseline - 6 months ] [ Designated as safety issue: No ]
- Changes in Motor Function and Activities of Daily Living [ Time Frame: Baseline - 6 months ] [ Designated as safety issue: No ]
- Changes in Brain Structure [ Time Frame: Baseline - 6 months ] [ Designated as safety issue: No ]
- Changes in Brain Glucose Metabolism [ Time Frame: Baseline - 2 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 20 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Allogeneic Umbilical Cord Blood
Allogeneic Umbilical Cord Blood Transplantation
|
Biological: Allogeneic Umbilical Cord Blood
Allogeneic Umbilical Cord Blood Transplantation via Intravenous or Intraarterial route
Other Name: Umbilical Cord Blood
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01451528
Contacts
| Contact: Minyoung Kim, M.D., Ph.D. | 82-780-1872 | kmin@cha.ac.kr |
| Contact: Kyunghoon Min, M.D. | 82-10-8973-3732 | minkh@chamc.co.kr |
Locations
| Korea, Republic of | |
| CHA Bundang Medical Center, CHA University | Not yet recruiting |
| Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712 | |
| Contact: Minyoung Kim, M.D., Ph.D. 82-31-780-1872 kmin@cha.ac.kr | |
| Sub-Investigator: Myung Seo Kang, M.D., Ph.D. | |
| Sub-Investigator: Sang Heum Kim, M.D. | |
| Sub-Investigator: Su Jin Jang, M.D. | |
| Sub-Investigator: Kyunghoon Min, M.D. | |
| Sub-Investigator: Junyoung Song, M.D. | |
Sponsors and Collaborators
Bundang CHA Hospital
Investigators
| Principal Investigator: | Minyoung Kim, M.D., Ph.D. | CHA Bundang Medical center, CHA university |
More Information
No publications provided
| Responsible Party: | MinYoung Kim, M.D., Associate Professor, Bundang CHA Hospital |
| ClinicalTrials.gov Identifier: | NCT01451528 History of Changes |
| Other Study ID Numbers: | TBIUCB, 2011-141 |
| Study First Received: | October 11, 2011 |
| Last Updated: | December 14, 2012 |
| Health Authority: | Korea: Institutional Review Board |
Keywords provided by Bundang CHA Hospital:
|
Umbilical Cord Blood Allogeneic Traumatic Brain Injury |
Additional relevant MeSH terms:
|
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013