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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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8 January 2018 |
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Main ID: |
NCT03123562 |
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Date of registration:
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17/04/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Improvement in Gross Motor Function and Muscle Tone in Children With Cerebral Palsy Related to Neonatal Icterus
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Scientific title:
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Improvement in Gross Motor Function and Muscle Tone in Children With Cerebral Palsy Related to Neonatal Icterus: An Open-label, Uncontrolled Clinical Trial |
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Date of first enrolment:
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April 1, 2014 |
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Target sample size:
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25 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03123562 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Vietnam
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Contacts
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Name:
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Liem T Nguyen, MD., PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Vinmec Research Institute of Stem Cell and Gene Technology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Cerebral palsy of any types caused by neonatal icterus
Exclusion Criteria:
- Epilepsy
- Hydrocephalus with ventricular drain
- Coagulation disorders
- Allergy to anesthetic agents
- Severe health conditions such as cancer, failure of heart, lung, liver or kidney
- Active infections
Age minimum:
1 Year
Age maximum:
15 Years
Gender:
All
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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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Combination Product: Stem cell transplantation
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Primary Outcome(s)
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GMFM-88 and GMFM-66 Percentile
[Time Frame: Time Frame: Baseline and 6 months after transplantation]
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Secondary Outcome(s)
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Change in Muscle tone
[Time Frame: Time Frame: Baseline and 6 months after transplantation]
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Number of adverse events
[Time Frame: Through study completion, an average of 6 months]
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Secondary ID(s)
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VinmecRISCGT68
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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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