NCT02983708

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

Neuroregenerative Potential of Intravenous G-CSF and Autologous Peripheral Blood Stem Cells in Children With Cerebral Palsy: a Randomized, Double-blind Cross-over Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Hanyang University Seoul Hospital · Academic / Other
• Sex: All
• Age: 2 Years – 10 Years
• Healthy volunteers: Not accepted

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.

Detailed description

We hypothesized that mobilized peripheral blood mononuclear cells (mPBMCs) would be a better source of cell therapy for children with CP, if these cells had a similar neuroregenerative potential to bone marrow/cord blood mononuclear cells (MNCs). Multipotent precursor cells exist in peripheral blood, and a fraction of elutriated blood cells from normal individuals contains MNCs that have the potential to be MSCs. There are several advantages to using mPBMCs for cell therapy in children with CP: the G-CSF that is used to mPBMCs has neuroregenerative potential; the collection and fractionation of stem cells can be repeated; and, the therapy is suitable for most children with CP.

Conditions

• Neurodegeneration
• G-CSF
• Peripheral Blood Mononuclear Cells
• Cerebral Palsy

Interventions

Type	Name	Description
BIOLOGICAL	Peripheral blood mononuclear cells (mPBMC)
DRUG	G-CSF
DRUG	Placebo

Timeline

• Start date: 2011-08-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2016-12-06
• Last updated: 2016-12-07