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NCT Number: NCT02983708

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

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.

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Key information

Conditions

Neurodegeneration Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy G-CSF Nerve Degeneration Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Blood Mononuclear Cells

Age range

2 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peripheral blood mononuclear cells (mPBMC)

Biological

G-CSF

Drug

Placebo

Drug

Primary outcomes

  1. Overall improvement as a score changes in GMFM > 4 points

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Hanyang University Seoul Hospital

Other

Collaborators

  • Ministry of Health & Welfare, Korea

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Dec 6, 2016
Registry last updated
Dec 7, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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