G-CSF and Autologous Cord Blood Infusion in Cerebral Palsy

August 10, 2016 updated by: Young-Ho Lee, Hanyang University Seoul Hospital

Phase II, Randomized, Double-blind Clinical Trial for Efficacy of G-CSF and Autologous Cord Blood Infusion in Children With Cerebral Palsy

This study is performed to reveal the safety and feasibility of combination therapy with autologous cord blood mononuclear cells (CB) and G-CSF as well as repeated administration of G-CSF for children with cerebral palsy. The evaluation tools are as follows: (1) Developmental tests (DDST, PEDI, GMFM, GMFCS, MACS, QUEST), (2) Neurocognitive function test (WPPSI-IV), (3) Brain MRI-DTI, (4) Peripheral blood CD34+ cell counts, (5) Neurotrophic factors/anti-inflammatory cytokines.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, KS013
        • Recruiting
        • Hanyang University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages from 2 years to 10 years at the time of enrollment
  • Non-severe type of cerebral palsy
  • Willing to comply with all study procedures

Exclusion Criteria:

  • Previous participation within 1 year in a clinical study with stem cell therapy including cord blood, G-CSF, and erythropoietin
  • Presence of chromosomal abnormalities
  • Unwillingness to participate clinical trial
  • Presence of hypersensitivity reaction to G-CSF
  • Evidence of hepatic, renal, cardiac dysfunctions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo (Normal saline)
Experimental: G-CSF
Drug: G-CSF (Leucostim)
Experimental: CB + G-CSF
Drug: G-CSF (Leucostim)
Biological: CB (autologous cord blood)
Placebo Comparator: CB + placebo
Biological: CB (autologous cord blood)
Drug: Placebo (Normal saline)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Confirm the safety of autologous cord blood infusion and repeated injection of G-CSF in children with cerebral palsy by repeated follow-up every 3 months over 18 months with clinical and laboratory evaluations
Time Frame: For 18 months from date of randomization
For 18 months from date of randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Confirm the efficacy of autologous cord blood infusion and/or G-CSF in children with cerebral palsy using standardized Gross Motor Function Measure evaluation.
Time Frame: Every 6 months from date of randomization up to 18 months
Every 6 months from date of randomization up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hanyang University Seoul Hospital

Collaborators

Ministry of Health & Welfare, Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

July 26, 2016

First Submitted That Met QC Criteria

August 10, 2016

First Posted (Estimate)

August 15, 2016

Study Record Updates

Last Update Posted (Estimate)

August 15, 2016

Last Update Submitted That Met QC Criteria

August 10, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-CB-G-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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