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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02983708

Enrollment

Registered

2016-12-06

Start date

2011-08-31

Completion date

2014-09-30

Last updated

2016-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Neuroregeneration, G-CSF, Peripheral blood mononuclear cells, Cerebral palsy

Brief 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.

Interventions

BIOLOGICALPeripheral blood mononuclear cells (mPBMC)

DRUGG-CSF

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Years to 10 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Overall improvement as a score changes in GMFM > 4 points	6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026