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

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ClinicalTrials.gov Identifier: NCT02983708
Recruitment Status : Completed
First Posted : December 6, 2016
Last Update Posted : December 7, 2016
Sponsor:
Collaborator:
Ministry of Health & Welfare, Korea
Information provided by (Responsible Party):
Young-Ho Lee, Hanyang University Seoul Hospital

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.

Condition or disease Intervention/treatment Phase
Neurodegeneration G-CSF Peripheral Blood Mononuclear Cells Cerebral Palsy Biological: Peripheral blood mononuclear cells (mPBMC) Drug: G-CSF Drug: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : August 2011
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: mPBMC group
G-CSF would be administered for 5 days and then mobilized peripheral blood mononuclear cells (mPBMCs) would be collected in all included patients. One month after cryopreservation of the mPBMCs (M1), patients will be randomized to receive either mPBMCs or placebo. Six months after randomization (M7), cross-over infusion of mPBMCs or placebo will be performed and the patients are observed for another 6 months. mPBMCs group would be included all patients who received mPBMCs at M1 or M7.
Biological: Peripheral blood mononuclear cells (mPBMC)
Drug: G-CSF
Placebo Comparator: Placebo group
G-CSF would be administered for 5 days and then mobilized peripheral blood mononuclear cells (mPBMCs) would be collected in all included patients. One month after cryopreservation of the mPBMCs (M1), patients will be randomized to receive either mPBMCs or placebo. Six months after randomization (M7), cross-over infusion of mPBMCs or placebo will be performed and the patients are observed for another 6 months. Placebo group would be included all patients who received placebo at M1 or M7.
Drug: G-CSF
Drug: Placebo



Primary Outcome Measures :
  1. Overall improvement as a score changes in GMFM > 4 points [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Young-Ho Lee, Professor, Hanyang University Seoul Hospital
ClinicalTrials.gov Identifier: NCT02983708     History of Changes
Other Study ID Numbers: CP-PB-2011
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We have to get individual permissions to make IPD available to other researchers.

Keywords provided by Young-Ho Lee, Hanyang University Seoul Hospital:
Neuroregeneration
G-CSF
Peripheral blood mononuclear cells
Cerebral palsy

Additional relevant MeSH terms:
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Cerebral Palsy
Brain Damage, Chronic
Brain Diseases
Pathologic Processes
Nerve Degeneration
Central Nervous System Diseases
Nervous System Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs