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G-CSF and Autologous Cord Blood Infusion in Cerebral Palsy

H

Hanyang University Seoul Hospital

Status and phase

Unknown
Phase 2

Conditions

Cerebral Palsy

Treatments

Drug: G-CSF (Leucostim)
Drug: Placebo (Normal saline)
Biological: CB (autologous cord blood)

Study type

Interventional

Funder types

Other

Identifiers

NCT02866331
CP-CB-G-2016

Details and patient eligibility

About

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.

Enrollment

88 estimated patients

Sex

All

Ages

2 to 10 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Ages from 2 years to 10 years at the time of enrollment
  • Non-severe type of cerebral palsy
  • Willing to comply with all study procedures

Exclusion criteria

  • Previous participation within 1 year in a clinical study with stem cell therapy including cord blood, G-CSF, and erythropoietin
  • Presence of chromosomal abnormalities
  • Unwillingness to participate clinical trial
  • Presence of hypersensitivity reaction to G-CSF
  • Evidence of hepatic, renal, cardiac dysfunctions

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

88 participants in 4 patient groups, including a placebo group

CB + G-CSF
Experimental group
Treatment:
Biological: CB (autologous cord blood)
Drug: G-CSF (Leucostim)
CB + placebo
Placebo Comparator group
Treatment:
Drug: Placebo (Normal saline)
Biological: CB (autologous cord blood)
G-CSF
Experimental group
Treatment:
Drug: G-CSF (Leucostim)
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo (Normal saline)

Trial contacts and locations

1

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Central trial contact

Young-Ho LEE, M.D., Ph.D.

Data sourced from clinicaltrials.gov

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