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

Phase 2

Withdrawn

• Conditions: Cerebral Palsy
• Interventions: Biological: Umbilical Cord Blood Infusion; Other: Active Rehabilitation; Other: Placebo Umbilical Cord Blood

• Registration Number: NCT01486732
• Lead Sponsor: Bundang CHA Hospital

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.

Study Timeline

• Study First Submitted: 2011-12-04
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-06
• Study Start: 2013-03
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-17
• Last Update Posted: 2013-11-19
• Primary Completion: 2014-04
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Umbilical Cord Blood & Rehabilitation	Umbilical Cord Blood Infusion	Allogeneic umbilical cord blood infusion and active rehabilitation
Umbilical Cord Blood & Rehabilitation	Active Rehabilitation	Allogeneic umbilical cord blood infusion and active rehabilitation
Placebo Umbilical Cord Blood & Rehabilitation	Active Rehabilitation	Placebo Umbilical Cord Blood infusion and active rehabilitation
Placebo Umbilical Cord Blood & Rehabilitation	Placebo Umbilical Cord Blood	Placebo Umbilical Cord Blood infusion and active rehabilitation

Primary Outcome Measures

Name	Time	Method
Comparison of FLT-PET Activity Change	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

Name	Time	Method
Changes in Standardized Gross Motor Function	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	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.
Changes in Neurodevelopmental Outcome	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).

Trial Locations

Locations (1)

CHA Bundang Medical Center; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of