G-CSF and Autologous Cord Blood Infusion in Cerebral Palsy

NCT02866331 | Unknown Phase 2 DMC

• 1 other identifier: CP-CB-G-2016
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (4)

CB + G-CSF

EXPERIMENTAL

Drug: G-CSF (Leucostim); Biological: CB (autologous cord blood)

CB + placebo

PLACEBO COMPARATOR

Biological: CB (autologous cord blood); Drug: Placebo (Normal saline)

G-CSF

EXPERIMENTAL

Drug: G-CSF (Leucostim)

Placebo

PLACEBO COMPARATOR

Drug: Placebo (Normal saline)

Interventions

G-CSF (Leucostim) DRUG

CB + G-CSF; G-CSF

CB (autologous cord blood) BIOLOGICAL

CB + G-CSF; CB + placebo

Placebo (Normal saline) DRUG

CB + placebo; Placebo

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanyang University Seoul Hospital: lead
• Ministry of Health & Welfare, Korea: collaborator

Study Sites (1)

Hanyang University Hospital

Seoul, Seoul, KS013, South Korea

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Granulocyte Colony-Stimulating Factor; Saline Solution

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

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

CONTACT

82-2-2290-8383; cord@hanyang.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Pediatrics

Study Record Dates

• First Submitted: July 26, 2016
• First Posted: August 15, 2016
• Study Start: July 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2018
• Last Updated: August 15, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

KR (1)