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
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.
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 :
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 ]
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Layout table for eligibility information
Ages Eligible for Study:
2 Years to 10 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
Previous participation within 1 year in a clinical study with stem cell therapy including cord blood, G-CSF, and erythropoietin