NCT01528436

Brief Summary

This randomized controlled study aims to evaluate the efficacy of umbilical cord blood therapy for children with cerebral palsy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

February 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 8, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 18, 2012

Status Verified

July 1, 2012

Enrollment Period

5 months

First QC Date

February 3, 2012

Last Update Submit

July 17, 2012

Conditions

Cerebral Palsy

Keywords

Cerebral PalsyUmbilical Cord BloodRehabilitation

Outcome Measures

Primary Outcomes (2)

  • Changes in Motor Performance

    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 (range: 0\~100, Higher value means better motor quality). We will report GMPM scores at each assessment time points.

    Baseline - 1 month - 3 months

  • 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 value means better gross motor function). We will report GMFM scores at each assessment time points.

    Baseline - 1 month - 3 months

Secondary Outcomes (7)

  • Changes in Cognitive Neurodevelopmental Outcome

    Baseline - 1 month - 3 months

  • Changes in Motor Neurodevelopmental Outcome

    Baseline - 1 month - 3 months

  • Changes in Functional Independence in Daily Activities

    Baseline - 1 month - 3 months

  • Changes in Visual Perception Test

    Baseline - 1 month - 3 months

  • Changes in Muscle Strength

    Baseline - 1 month - 3 months

  • +2 more secondary outcomes

Study Arms (2)

Umbilical Cord Blood and Rehabilitation

EXPERIMENTAL

Allogeneic Umbilical Cord Blood infusion and Active Rehabilitation

Biological: Umbilical Cord Blood InfusionOther: Active Rehabilitation

Placebo Umbilical Cord Blood and Rehabilitation

ACTIVE COMPARATOR

Placebo Umbilical Cord Blood infusion and Active Rehabilitation

Other: Placebo Umbilical Cord BloodOther: Active Rehabilitation

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 and Rehabilitation
Placebo Umbilical Cord BloodOTHER

Placebo Umbilical Cord Blood that resembles cord blood in appearance was designed.

Placebo Umbilical Cord Blood and 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 should continue to receive rehabilitation therapy at least 3 days per week until the study completion.

Placebo Umbilical Cord Blood and RehabilitationUmbilical Cord Blood and Rehabilitation

Eligibility Criteria

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

You may qualify if:

  • Cerebral Palsy with 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, CHA University

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

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
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 3, 2012

First Posted

February 8, 2012

Study Start

February 1, 2012

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 18, 2012

Record last verified: 2012-07

Locations

KR(1)