Neuroregenerative Potential of Intravenous G-CSF and Autologous Peripheral Blood Stem Cells

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The current study describes a randomized, double-blind, cross-over study of intravenous G-CSF followed by infusion with autologous mobilized peripheral blood mononuclear cells (mPBMCs) in children with cerebral palsy (CP) to determine the safety and feasibility of the procedure, as well as the potential efficacy for improving neurological impairment.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Non severe type of cerebral palsy

• Evidences of abnormal MRI findings such as periventricular leukomalacia

• Collected mobilized peripheral blood mononuclear cell counts > 1×10^8/kg or CD34+ cell counts > 1×10^6/kg

• Consent form

Exclusion Criteria:

• Previous trials of autologous cord blood infusion or erythropoietin/G-CSF

• Chromosomal abnormalities