G-CSF and Autologous Cord Blood Infusion in Cerebral Palsy

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

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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)