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G-CSF and Autologous Cord Blood Infusion in Cerebral Palsy

Cerebral Palsy Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02866331
Study type Interventional
Source Hanyang University Seoul Hospital
Contact Young-Ho LEE, M.D., Ph.D.
Phone 82-2-2290-8383
Email cord@hanyang.ac.kr
Status Recruiting
Phase Phase 2
Start date July 2016
Completion date December 2018
View Details
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