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

Primary Purpose

Cerebral Palsy

Status
Withdrawn
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Umbilical Cord Blood Infusion
Active Rehabilitation
Placebo Umbilical Cord Blood
Sponsored by
Bundang CHA Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cerebral Palsy focused on measuring Cerebral Palsy, Umbilical Cord Blood, FLT-PET

Eligibility Criteria

6 Months - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHA Bundang Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Umbilical Cord Blood & Rehabilitation

Placebo Umbilical Cord Blood & Rehabilitation

Arm Description

Allogeneic umbilical cord blood infusion and active rehabilitation

Placebo Umbilical Cord Blood infusion and active rehabilitation

Outcomes

Primary Outcome Measures

Comparison of FLT-PET Activity Change
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
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
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
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.

Full Information

First Posted
December 4, 2011
Last Updated
November 17, 2013
Sponsor
Bundang CHA Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01486732
Brief Title
FLT-PET Activity Change After Allogeneic Umbilical Cord Blood (UCB) Therapy in Cerebral Palsy
Official Title
FLT(3'-Deoxy-3'-[F-18]Fluorothymidine)-PET Activity Change After Allogeneic Umbilical Cord Blood Cell Therapy in Cerebral Palsy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Withdrawn
Why Stopped
Difficulty in obtaining specific isotope tracer
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bundang CHA Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
Keywords
Cerebral Palsy, Umbilical Cord Blood, FLT-PET

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Umbilical Cord Blood & Rehabilitation
Arm Type
Experimental
Arm Description
Allogeneic umbilical cord blood infusion and active rehabilitation
Arm Title
Placebo Umbilical Cord Blood & Rehabilitation
Arm Type
Active Comparator
Arm Description
Placebo Umbilical Cord Blood infusion and active rehabilitation
Intervention Type
Biological
Intervention Name(s)
Umbilical Cord Blood Infusion
Other Intervention Name(s)
Donated Umbilical Cord Blood Units from Affiliated Cord Blood Bank
Intervention Description
The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.
Intervention Type
Other
Intervention Name(s)
Active Rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo Umbilical Cord Blood
Intervention Description
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
Primary Outcome Measure Information:
Title
Comparison of FLT-PET Activity Change
Description
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.
Time Frame
Baseline - 2 weeks
Secondary Outcome Measure Information:
Title
Changes in Neurodevelopmental Outcome
Description
Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor and Mental Scales (Higher score means better motor and mental function).
Time Frame
Baseline - 2 weeks - 3 months
Title
Changes in Standardized Gross Motor Function
Description
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).
Time Frame
Baseline - 2 weeks - 3 months
Title
Changes in Quality of Movement
Description
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.
Time Frame
Baseline - 2 weeks - 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Minyoung Kim, M.D., Ph.D.
Organizational Affiliation
CHA University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHA Bundang Medical Center
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-712
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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