G-CSF and Autologous Cord Blood Infusion in Cerebral Palsy

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

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.

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