Back to resultsG-CSF and Autologous Cord Blood Infusion in Cerebral Palsy
Primary Purpose
Cerebral Palsy
Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
G-CSF (Leucostim)
CB (autologous cord blood)
Placebo (Normal saline)
Sponsored by
About this trial
This is an interventional treatment trial for Cerebral Palsy
Eligibility Criteria
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
Sites / Locations
- Hanyang University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
CB + G-CSF
CB + placebo
G-CSF
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Confirm the efficacy of autologous cord blood infusion and/or G-CSF in children with cerebral palsy using standardized Gross Motor Function Measure evaluation.
Full Information
NCT ID
NCT02866331
First Posted
July 26, 2016
Last Updated
August 10, 2016
Sponsor
Hanyang University Seoul Hospital
Collaborators
Ministry of Health & Welfare, Korea
1. Study Identification
Unique Protocol Identification Number
NCT02866331
Brief Title
G-CSF and Autologous Cord Blood Infusion in Cerebral Palsy
Official Title
Phase II, Randomized, Double-blind Clinical Trial for Efficacy of G-CSF and Autologous Cord Blood Infusion in Children With Cerebral Palsy
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hanyang University Seoul Hospital
Collaborators
Ministry of Health & Welfare, Korea
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Palsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CB + G-CSF
Arm Type
Experimental
Arm Title
CB + placebo
Arm Type
Placebo Comparator
Arm Title
G-CSF
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
G-CSF (Leucostim)
Intervention Type
Biological
Intervention Name(s)
CB (autologous cord blood)
Intervention Type
Drug
Intervention Name(s)
Placebo (Normal saline)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Young-Ho LEE, M.D., Ph.D.
Phone
82-2-2290-8383
Email
cord@hanyang.ac.kr
Facility Information:
Facility Name
Hanyang University Hospital
City
Seoul
ZIP/Postal Code
KS013
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young-Ho LEE, M.D., Ph.D.
Phone
82-2-2290-8383
Email
cord@hanyang.ac.kr
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
G-CSF and Autologous Cord Blood Infusion in Cerebral Palsy
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