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

This study has suspended participant recruitment.
(KFDA(Korea Food and Drug Administration) Permission Pending)
Sponsor:
Information provided by (Responsible Party):
MinYoung Kim, M.D., Bundang CHA Hospital
ClinicalTrials.gov Identifier:
NCT01486732
First received: December 4, 2011
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
  Purpose

This is randomized placebo-controlled trial to recognize new cell regeneration in the brain using FLT-PET.


Condition Intervention Phase
Cerebral Palsy
 Biological: Umbilical Cord Blood Infusion
Other: Active Rehabilitation
Other: Placebo Umbilical Cord Blood
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: FLT(3'-Deoxy-3'-[F-18]Fluorothymidine)-PET Activity Change After Allogeneic Umbilical Cord Blood Cell Therapy in Cerebral Palsy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bundang CHA Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 40
Study Start Date: March 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 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
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 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

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.

  Eligibility

Ages Eligible for Study:   6 Months to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486732

Locations
Korea, Republic of
CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-712
Sponsors and Collaborators
Bundang CHA Hospital
Investigators
Principal Investigator: Minyoung Kim, M.D., Ph.D. CHA Bundang Medical center, CHA university
  More Information

No publications provided

Responsible Party: MinYoung Kim, M.D., Associate Professor, Bundang CHA Hospital
ClinicalTrials.gov Identifier: NCT01486732     History of Changes
Other Study ID Numbers: CP FLT-PET
Study First Received: December 4, 2011
Last Updated: July 24, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Bundang CHA Hospital:
Cerebral Palsy
Umbilical Cord Blood
FLT-PET

Additional relevant MeSH terms:
Cerebral Palsy
Paralysis
Brain Damage, Chronic
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on June 18, 2013