NCT02025972

Brief Summary

This open-label study aims to analyze cytokines related to clinical outcomes of allogeneic 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
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

Typical duration for not_applicable

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

December 1, 2013

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2015

Completed
Last Updated

October 12, 2017

Status Verified

October 1, 2017

Enrollment Period

2 years

First QC Date

December 29, 2013

Last Update Submit

October 10, 2017

Conditions

Cerebral Palsy

Keywords

Cerebral palsyUmbilical cord bloodRehabilitationCytokineOutcome

Outcome Measures

Primary Outcomes (5)

  • Cytokine analysis

    Cytokine analysis

    12 months

  • Changes in Standardized Gross Motor Function

    GMFM (Gross Motor Function Measure) is 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).

    Baseline - 3 months - 6 months - 12months

  • Changes in Motor Performance

    GMPM (Gross Motor Performance Measure) is 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).

    Baseline - 3 months - 6 months - 12 months

  • Changes in Cognitive Neurodevelopmental Outcome

    Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Mental Scale (range: 0\~178; worst: 0, best: 178)

    Baseline - 3 months - 6 months - 12 months

  • Changes in Motor Neurodevelopmental Outcome

    Korean version of Bayley Scale of Infant Development-II (K-BSID-II) Motor Scale (range: 0\~112; worst: 0, best: 112)

    Baseline - 3 months - 6 months - 12 months

Secondary Outcomes (14)

  • Changes in Gross Motor Function Classification System

    Baseline - 3 months - 6 months - 12 months

  • Changes in Functional Independence in Daily Activities

    Baseline - 3 months - 6 months - 12 months

  • Changes in Functional Performance in Daily Activities

    Baseline - 3 months - 6 months - 12 months

  • Changes in Upper Extremity Function

    Baseline - 3 months - 6 months - 12 months

  • Changes in Visual Perception Test

    Baseline - 3 months - 6 months - 12 months

  • +9 more secondary outcomes

Study Arms (1)

Allogeneic umbilical cord blood therapy

EXPERIMENTAL

Allogeneic umbilical cord blood therapy

Procedure: Allogeneic umbilical cord blood therapy

Interventions

Allogeneic umbilical cord blood therapyPROCEDURE
Allogeneic umbilical cord blood therapy

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Diagnosed with cerebral palsy
  • Age of ≤15 years
  • Mismatch in HLA-A, B, and DR ≤2, and total nucleated cell count ≥3x10\^7/kg. If the cell count is less than given values, more than 1 unit could be used.
  • Decision of participation in the study by and acquisition of informed consent from the subject's representative
  • Willingness and ability to be hospitalized according to the schedule specified in the protocol and continue the study for 12 months after study entry

You may not qualify if:

  • Current aspiration pneumonia
  • Known genetic disease
  • History of hypersensitivity reaction to any study drugs pertinent to the study
  • Patient with severe seizure disease who has clinical convulsion despite combination therapy with 3 or more agents
  • Uncontrolled hypertension defined as systolic blood pressure \>115 mmHg and/or diastolic blood pressure \>70 mmHg
  • Hepatic impairment defined as asparate aminotransferase (AST) \>55 IU/L and/or alanine aminotransferase (ALT) \>45 IU/L
  • Renal impairment defined as creatinine (Cr) ≥1.2 mg/dL
  • Presence of diagnosed or suspected malignant tumor and/or hematologic malignancy
  • Non-compliance with study visits specified in the protocol or unwillingness of care-giver due to lack of understanding of the patient

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
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of CHA University, M.D., Ph.D.

Study Record Dates

First Submitted

December 29, 2013

First Posted

January 1, 2014

Study Start

December 1, 2013

Primary Completion

November 15, 2015

Study Completion

November 15, 2015

Last Updated

October 12, 2017

Record last verified: 2017-10

Locations

KR(1)