- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01486732
FLT-PET Activity Change After Allogeneic Umbilical Cord Blood (UCB) Therapy in Cerebral Palsy
November 17, 2013 updated by: MinYoung Kim, M.D., Bundang CHA Hospital
FLT(3'-Deoxy-3'-[F-18]Fluorothymidine)-PET Activity Change After Allogeneic Umbilical Cord Blood Cell Therapy in Cerebral Palsy
This is randomized placebo-controlled trial to recognize new cell regeneration in the brain using FLT-PET.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
FLT(3'-Deoxy-3'-[F-18]Fluorothymidine) has been developed as a cell-proliferation tracer.
In animal study, FLT-PET was used as a tool that enables imaging and measuring of proliferation in the brain, thus it detects activity of endogenous neural stem cells noninvasively.
This study aims to assess cell proliferation activity changes in the brain after Umbilical Cord Blood (UCB)Therapy for Cerebral Palsy patients using FLT-PET.
Study Type
Interventional
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Gyeonggi-do
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Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
- CHA Bundang Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 20 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Umbilical Cord Blood & Rehabilitation
Allogeneic umbilical cord blood infusion and active rehabilitation
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The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.
Other Names:
All subjects should participate in active rehabilitation.
They will receive two physical and occupational therapy sessions per day.
Post discharge, each participant continued to receive rehabilitation therapy at least 3 days per week for additional 2.5 months.
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Active Comparator: Placebo Umbilical Cord Blood & Rehabilitation
Placebo Umbilical Cord Blood infusion and active rehabilitation
|
All subjects should participate in active rehabilitation.
They will receive two physical and occupational therapy sessions per day.
Post discharge, each participant continued to receive rehabilitation therapy at least 3 days per week for additional 2.5 months.
Placebo Umbilical Cord Blood that resembles cord blood in appearance was designed : 1.5 to 3 ml of the subject's own blood was collected and mixed with 15 to 20 ml of albumin
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of FLT-PET Activity Change
Time Frame: Baseline - 2 weeks
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Comparison of FLT-PET Activity Change between UCB group and Placebo group during 2 weeks: To compare differences in regional brain FLT-PET activity between groups and differences between pre- and post-therapy imaging data.
The baseline and post-therapy data of each group will be compared using paired t-test statistics.
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Baseline - 2 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Neurodevelopmental Outcome
Time Frame: Baseline - 2 weeks - 3 months
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Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor and Mental Scales (Higher score means better motor and mental function).
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Baseline - 2 weeks - 3 months
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Changes in Standardized Gross Motor Function
Time Frame: Baseline - 2 weeks - 3 months
|
GMFM (Gross Motor Function Measure) as a standardized measurement tool for assessing Gross Motor Function consisting of sub-scales; lying & rolling, sitting, crawling & kneeling, standing, walking, running & jumping (range: 0~100 %, Higher score means better motor function).
|
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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GMPM (Gross Motor Performance Measure) as a standardized measurement tool for assessing quality of movement regarding 3 properties of 5 ones; alignment, coordination, dissociated movement, stability, and weight shift.
|
Baseline - 2 weeks - 3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (Anticipated)
April 1, 2014
Study Completion (Anticipated)
July 1, 2014
Study Registration Dates
First Submitted
December 4, 2011
First Submitted That Met QC Criteria
December 5, 2011
First Posted (Estimate)
December 6, 2011
Study Record Updates
Last Update Posted (Estimate)
November 19, 2013
Last Update Submitted That Met QC Criteria
November 17, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CP FLT-PET
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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