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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01486732 |
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Date of registration:
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04/12/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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FLT-PET Activity Change After Allogeneic Umbilical Cord Blood (UCB) Therapy in Cerebral Palsy
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Scientific title:
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FLT(3'-Deoxy-3'-[F-18]Fluorothymidine)-PET Activity Change After Allogeneic Umbilical Cord Blood Cell Therapy in Cerebral Palsy |
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Date of first enrolment:
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March 2013 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT01486732 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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Minyoung Kim, M.D., Ph.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHA University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Cerebral Palsy
- Abnormal muscle tone
- Gross Motor Function Classification System (GMFCS): I, II, III, IV, V
- Willing to comply with all study procedure
Exclusion Criteria:
- Medical instability including pneumonia or renal function at enrollment
- Presence of known genetic disease
- Presence of drug hypersensitivity which is related to this study remedy
- Poor cooperation of guardian,including inactive attitude for rehabilitation and
visits for follow-up
- Decision by the principal investigator when there are unexpected events including
brain surgery, that may affect the outcome
Age minimum:
6 Months
Age maximum:
20 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cerebral Palsy
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Intervention(s)
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Biological: Umbilical Cord Blood Infusion
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Other: Active Rehabilitation
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Other: Placebo Umbilical Cord Blood
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Primary Outcome(s)
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Comparison of FLT-PET Activity Change
[Time Frame: Baseline - 2 weeks]
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Secondary Outcome(s)
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Changes in Neurodevelopmental Outcome
[Time Frame: Baseline - 2 weeks - 3 months]
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Changes in Quality of Movement
[Time Frame: Baseline - 2 weeks - 3 months]
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Changes in Standardized Gross Motor Function
[Time Frame: Baseline - 2 weeks - 3 months]
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Secondary ID(s)
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CP FLT-PET
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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