G-CSF and Autologous Cord Blood Infusion in Cerebral Palsy

Phase 2

• Conditions: Cerebral Palsy
• Interventions: Drug: G-CSF (Leucostim); Biological: CB (autologous cord blood); Drug: Placebo (Normal saline)

• Registration Number: NCT02866331
• Lead Sponsor: Hanyang University Seoul Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-26
• Status Verified: 2016-08
• Study First Submitted QC: 2016-08-10
• Last Update Submitted: 2016-08-10
• Study First Posted: 2016-08-15
• Last Update Posted: 2016-08-15
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 88

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CB + G-CSF	G-CSF (Leucostim)	-
CB + G-CSF	CB (autologous cord blood)	-
CB + placebo	CB (autologous cord blood)	-
CB + placebo	Placebo (Normal saline)	-
G-CSF	G-CSF (Leucostim)	-
Placebo	Placebo (Normal saline)	-

Primary Outcome Measures

Name	Time	Method
Confirm the safety of autologous cord blood infusion and repeated injection of G-CSF in children with cerebral palsy by repeated follow-up every 3 months over 18 months with clinical and laboratory evaluations	For 18 months from date of randomization

Secondary Outcome Measures

Name	Time	Method
Confirm the efficacy of autologous cord blood infusion and/or G-CSF in children with cerebral palsy using standardized Gross Motor Function Measure evaluation.	Every 6 months from date of randomization up to 18 months

Trial Locations

Locations (1)

Hanyang University Hospital; 🇰🇷 Seoul, Korea, Republic of