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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This study has been withdrawn prior to enrollment.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:
ClinicalTrials.gov Identifier:
NCT01486732
First Posted: December 6, 2011
Last Update Posted: November 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MinYoung Kim, M.D., Bundang CHA Hospital
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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:


Further study details as provided by MinYoung Kim, M.D., Bundang CHA Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 0
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.
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 University
  More Information

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
First Submitted: December 4, 2011
First Posted: December 6, 2011
Last Update Posted: November 19, 2013
Last Verified: November 2013

Keywords provided by MinYoung Kim, M.D., Bundang CHA Hospital:
Cerebral Palsy
Umbilical Cord Blood
FLT-PET

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