FLT-PET Activity Change After Allogeneic Umbilical Cord Blood (UCB) Therapy in Cerebral Palsy
|ClinicalTrials.gov Identifier: NCT01486732|
Recruitment Status : Withdrawn (Difficulty in obtaining specific isotope tracer)
First Posted : December 6, 2011
Last Update Posted : November 19, 2013
|Condition or disease||Intervention/treatment||Phase|
|Cerebral Palsy||Biological: Umbilical Cord Blood Infusion Other: Active Rehabilitation Other: Placebo Umbilical Cord Blood||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||FLT(3'-Deoxy-3'-[F-18]Fluorothymidine)-PET Activity Change After Allogeneic Umbilical Cord Blood Cell Therapy in Cerebral Palsy|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||July 2014|
Experimental: Umbilical Cord Blood & Rehabilitation
Allogeneic umbilical cord blood infusion and active rehabilitation
Biological: Umbilical Cord Blood Infusion
The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.
Other Name: Donated Umbilical Cord Blood Units from Affiliated Cord Blood BankOther: 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.
Active Comparator: Placebo Umbilical Cord Blood & Rehabilitation
Placebo Umbilical Cord Blood infusion and active rehabilitation
Other: 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.Other: Placebo Umbilical Cord Blood
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
- Comparison of FLT-PET Activity Change [ Time Frame: Baseline - 2 weeks ]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.
- Changes in Neurodevelopmental Outcome [ Time Frame: Baseline - 2 weeks - 3 months ]Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor and Mental Scales (Higher score means better motor and mental function).
- 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).
- Changes in Quality of Movement [ Time Frame: Baseline - 2 weeks - 3 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01486732
|Korea, Republic of|
|CHA Bundang Medical Center|
|Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712|
|Principal Investigator:||Minyoung Kim, M.D., Ph.D.||CHA University|