G-CSF and Autologous Cord Blood Infusion in Cerebral Palsy

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanyang University Seoul Hospital
• Collaborator: Ministry of Health & Welfare, Korea
• Treatments: Lenograstim

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