NCT01486732

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 6, 2011

Completed
1.2 years until next milestone

Study Start

First participant enrolled

March 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

November 19, 2013

Status Verified

November 1, 2013

Enrollment Period

1.1 years

First QC Date

December 4, 2011

Last Update Submit

November 17, 2013

Conditions

Cerebral Palsy

Keywords

Cerebral PalsyUmbilical Cord BloodFLT-PET

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • Changes in Neurodevelopmental Outcome

    Baseline - 2 weeks - 3 months

  • Changes in Standardized Gross Motor Function

    Baseline - 2 weeks - 3 months

  • Changes in Quality of Movement

    Baseline - 2 weeks - 3 months

Study Arms (2)

Umbilical Cord Blood & Rehabilitation

EXPERIMENTAL

Allogeneic umbilical cord blood infusion and active rehabilitation

Biological: Umbilical Cord Blood InfusionOther: Active Rehabilitation

Placebo Umbilical Cord Blood & Rehabilitation

ACTIVE COMPARATOR

Placebo Umbilical Cord Blood infusion and active rehabilitation

Other: Active RehabilitationOther: Placebo Umbilical Cord Blood

Interventions

Umbilical Cord Blood InfusionBIOLOGICAL

The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.

Also known as: Donated Umbilical Cord Blood Units from Affiliated Cord Blood Bank
Umbilical Cord Blood & Rehabilitation
Active RehabilitationOTHER

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 & RehabilitationUmbilical Cord Blood & Rehabilitation
Placebo Umbilical Cord BloodOTHER

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

Placebo Umbilical Cord Blood & Rehabilitation

Eligibility Criteria

Age6 Months - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Cerebral Palsy
  • Abnormal muscle tone
  • Gross Motor Function Classification System (GMFCS): I, II, III, IV, V
  • Willing to comply with all study procedure

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHA Bundang Medical Center

Seongnam-si, Gyeonggi-do, 463-712, South Korea

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Minyoung Kim, M.D., Ph.D.

    CHA University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 4, 2011

First Posted

December 6, 2011

Study Start

March 1, 2013

Primary Completion

April 1, 2014

Study Completion

July 1, 2014

Last Updated

November 19, 2013

Record last verified: 2013-11

Locations

KR(1)