G-CSF and Autologous Cord Blood Infusion in Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

Phase II, Randomized, Double-blind Clinical Trial for Efficacy of G-CSF and Autologous Cord Blood Infusion in Children With Cerebral Palsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02866331
• Other study ID #: CP-CB-G-2016
• Status: Recruiting
• Phase: Phase 2
• First received: July 26, 2016
• Last updated: August 10, 2016
• Start date: July 2016
• Est. completion date: December 2018

Study information

• Verified date: August 2016
• Source: Hanyang University Seoul Hospital
• Contact: Young-Ho LEE, M.D., Ph.D.
• Phone: 82-2-2290-8383
• Email: cord[@]hanyang.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Ministry for Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 10 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Paralysis

Intervention

Drug:
• G-CSF (Leucostim)

Biological:
• CB (autologous cord blood)

Drug:
• Placebo (Normal saline)

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Hanyang University Seoul Hospital	Ministry of Health & Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No