Umbilical Cord Blood Therapy for Children With Cerebral Palsy
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01639404 |
Recruitment Status :
Completed
First Posted : July 12, 2012
Last Update Posted : August 12, 2013
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Sponsor:
MinYoung Kim, M.D.
Information provided by (Responsible Party):
MinYoung Kim, M.D., Bundang CHA Hospital
Tracking Information | ||||
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First Submitted Date ICMJE | July 10, 2012 | |||
First Posted Date ICMJE | July 12, 2012 | |||
Last Update Posted Date | August 12, 2013 | |||
Study Start Date ICMJE | July 2012 | |||
Actual Primary Completion Date | March 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | Complete list of historical versions of study NCT01639404 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Umbilical Cord Blood Therapy for Children With Cerebral Palsy | |||
Official Title ICMJE | Allogeneic Umbilical Cord Blood Therapy for Children With Cerebral Palsy | |||
Brief Summary | This study aims to evaluate the efficacy of umbilical cord blood therapy for children with cerebral palsy. | |||
Detailed Description | Cerebral palsy is a disorder of movement and posture resulted from a non-progressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability. Many experimental animal studies have revealed that umbilical cord blood is useful to repair neurological injury in brain. On the basis of many experimental studies, umbilical cord blood is suggested as a potential therapy for cerebral palsy. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Not Applicable | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Cerebral Palsy | |||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Umbilical Cord Blood and Rehabilitation
Allogeneic Umbilical Cord Blood Administration and Active Rehabilitation
Interventions:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
17 | |||
Original Estimated Enrollment ICMJE |
18 | |||
Actual Study Completion Date ICMJE | March 2013 | |||
Actual Primary Completion Date | March 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 6 Months to 20 Years (Child, Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Korea, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01639404 | |||
Other Study ID Numbers ICMJE | CPUCB | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | MinYoung Kim, M.D., Bundang CHA Hospital | |||
Study Sponsor ICMJE | MinYoung Kim, M.D. | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Bundang CHA Hospital | |||
Verification Date | August 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |