FLT-PET Activity Change After Allogeneic Umbilical Cord Blood (UCB) Therapy in Cerebral Palsy

This study has been withdrawn prior to enrollment.
(Difficulty in obtaining specific isotope tracer)
Sponsor:
Information provided by (Responsible Party):
MinYoung Kim, M.D., Bundang CHA Hospital
ClinicalTrials.gov Identifier:
NCT01486732
First received: December 4, 2011
Last updated: November 17, 2013
Last verified: November 2013

December 4, 2011
November 17, 2013
March 2013
April 2014   (final data collection date for primary outcome measure)
Comparison of FLT-PET Activity Change [ Time Frame: Baseline - 2 weeks ] [ Designated as safety issue: No ]
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.
Comparison of FLT-PET Activity Change [ Time Frame: Baseline - 2 weeks ] [ Designated as safety issue: No ]
Comparison of FLT-PET Activity Change between UCB group and Placebo group during 2 weeks
Complete list of historical versions of study NCT01486732 on ClinicalTrials.gov Archive Site
  • Changes in Neurodevelopmental Outcome [ Time Frame: Baseline - 2 weeks - 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
FLT-PET Activity Change After Allogeneic Umbilical Cord Blood (UCB) Therapy in Cerebral Palsy
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cerebral Palsy
  • 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 Bank
  • 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 Name: Active Rehabilitation
  • 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
  • Experimental: Umbilical Cord Blood & Rehabilitation
    Allogeneic umbilical cord blood infusion and active rehabilitation
    Interventions:
    • Biological: Umbilical Cord Blood Infusion
    • Other: Active Rehabilitation
  • Active Comparator: Placebo Umbilical Cord Blood & Rehabilitation
    Placebo Umbilical Cord Blood infusion and active rehabilitation
    Interventions:
    • Other: Active Rehabilitation
    • Other: Placebo Umbilical Cord Blood
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
July 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
6 Months to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT01486732
CP FLT-PET
No
MinYoung Kim, M.D., Bundang CHA Hospital
Bundang CHA Hospital
Not Provided
Principal Investigator: Minyoung Kim, M.D., Ph.D. CHA University
Bundang CHA Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP