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G-CSF and Autologous Cord Blood Infusion in Cerebral Palsy

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ClinicalTrials.gov Identifier: NCT02866331
Recruitment Status : Unknown
Verified August 2016 by Young-Ho Lee, Hanyang University Seoul Hospital.
Recruitment status was:  Recruiting
First Posted : August 15, 2016
Last Update Posted : August 15, 2016
Sponsor:
Collaborator:
Ministry of Health & Welfare, Korea
Information provided by (Responsible Party):
Young-Ho Lee, Hanyang University Seoul Hospital

Tracking Information
First Submitted Date  ICMJE July 26, 2016
First Posted Date  ICMJE August 15, 2016
Last Update Posted Date August 15, 2016
Study Start Date  ICMJE July 2016
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 10, 2016)
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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE G-CSF and Autologous Cord Blood Infusion in Cerebral Palsy
Official Title  ICMJE Phase II, Randomized, Double-blind Clinical Trial for Efficacy of G-CSF and Autologous Cord Blood Infusion in Children With Cerebral Palsy
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Palsy
Intervention  ICMJE
  • Drug: G-CSF (Leucostim)
  • Biological: CB (autologous cord blood)
  • Drug: Placebo (Normal saline)
Study Arms  ICMJE
  • Experimental: CB + G-CSF
    Interventions:
    • Drug: G-CSF (Leucostim)
    • Biological: CB (autologous cord blood)
  • Placebo Comparator: CB + placebo
    Interventions:
    • Biological: CB (autologous cord blood)
    • Drug: Placebo (Normal saline)
  • Experimental: G-CSF
    Intervention: Drug: G-CSF (Leucostim)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo (Normal saline)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 10, 2016)
88
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2018
Estimated Primary Completion Date December 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 10 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02866331
Other Study ID Numbers  ICMJE CP-CB-G-2016
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Young-Ho Lee, Hanyang University Seoul Hospital
Study Sponsor  ICMJE Hanyang University Seoul Hospital
Collaborators  ICMJE Ministry of Health & Welfare, Korea
Investigators  ICMJE Not Provided
PRS Account Hanyang University Seoul Hospital
Verification Date August 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP