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

Cerebral Palsy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983708
• Other study ID #: CP-PB-2011
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 2, 2016
• Last updated: December 5, 2016
• Start date: August 2011
• Est. completion date: September 2014

Study information

• Verified date: December 2016
• Source: Hanyang University Seoul Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 10 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Biological:
• Peripheral blood mononuclear cells (mPBMC)

Drug:
• G-CSF

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Hanyang University Seoul Hospital	Ministry of Health & Welfare, Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall improvement as a score changes in GMFM > 4 points		6 months	Yes