ClinicalTrials.gov
ClinicalTrials.gov Menu

G-CSF and Autologous Cord Blood Infusion in Cerebral Palsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Cerebral Palsy Drug: G-CSF (Leucostim) Biological: CB (autologous cord blood) Drug: Placebo (Normal saline) Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
Experimental: G-CSF Drug: G-CSF (Leucostim)
Placebo Comparator: Placebo Drug: Placebo (Normal saline)



Primary Outcome Measures :
  1. 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 Measures :
  1. 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866331


Contacts
Contact: Young-Ho LEE, M.D., Ph.D. 82-2-2290-8383 cord@hanyang.ac.kr

Locations
Korea, Republic of
Hanyang University Hospital Recruiting
Seoul, Korea, Republic of, KS013
Contact: Young-Ho LEE, M.D., Ph.D.    82-2-2290-8383    cord@hanyang.ac.kr   
Sponsors and Collaborators
Hanyang University Seoul Hospital
Ministry of Health & Welfare, Korea

Responsible Party: Young-Ho Lee, Professor, Department of Pediatrics, Hanyang University Seoul Hospital
ClinicalTrials.gov Identifier: NCT02866331     History of Changes
Other Study ID Numbers: CP-CB-G-2016
First Posted: August 15, 2016    Key Record Dates
Last Update Posted: August 15, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Additional relevant MeSH terms:
Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs