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G-CSF and Autologous Cord Blood Infusion in Cerebral Palsy

NCT02866331 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2016-08-15

No results posted yet for this study

Summary

This study is performed to reveal the safety and feasibility of combination therapy with autologous cord blood mononuclear cells (CB) and G-CSF as well as repeated administration of G-CSF for children with cerebral palsy. The evaluation tools are as follows: (1) Developmental tests (DDST, PEDI, GMFM, GMFCS, MACS, QUEST), (2) Neurocognitive function test (WPPSI-IV), (3) Brain MRI-DTI, (4) Peripheral blood CD34+ cell counts, (5) Neurotrophic factors/anti-inflammatory cytokines.

Conditions

  • Cerebral Palsy

Interventions

DRUG

G-CSF (Leucostim)

BIOLOGICAL

CB (autologous cord blood)

DRUG

Placebo (Normal saline)

Sponsors & Collaborators

  • Ministry of Health & Welfare, Korea

    collaborator OTHER_GOV

  • Hanyang University Seoul Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02866331 on ClinicalTrials.gov