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

Cerebral Palsy Clinical Trial

Official title:

FLT(3'-Deoxy-3'-[F-18]Fluorothymidine)-PET Activity Change After Allogeneic Umbilical Cord Blood Cell Therapy in Cerebral Palsy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01486732
• Other study ID #: CP FLT-PET
• Status: Withdrawn
• Phase: Phase 2
• First received: December 4, 2011
• Last updated: November 17, 2013
• Start date: March 2013
• Est. completion date: July 2014

Study information

• Verified date: November 2013
• Source: Bundang CHA Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 20 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Biological:
• Umbilical Cord Blood Infusion
The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.

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.
• 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

Locations

Country	Name	City	State
Korea, Republic of	CHA Bundang Medical Center	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Bundang CHA Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline - 2 weeks	No
Secondary	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).	Baseline - 2 weeks - 3 months	No
Secondary	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).	Baseline - 2 weeks - 3 months	No
Secondary	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.	Baseline - 2 weeks - 3 months	No