G-CSF and Autologous Cord Blood Infusion in Cerebral Palsy

NCT ID: NCT02866331

Last Updated: 2016-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-31

Study Completion Date

2018-12-31

Brief Summary

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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

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Conditions

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Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CB + G-CSF

Group Type EXPERIMENTAL

G-CSF (Leucostim)

Intervention Type DRUG

CB (autologous cord blood)

Intervention Type BIOLOGICAL

CB + placebo

Group Type PLACEBO_COMPARATOR

CB (autologous cord blood)

Intervention Type BIOLOGICAL

Placebo (Normal saline)

Intervention Type DRUG

G-CSF

Group Type EXPERIMENTAL

G-CSF (Leucostim)

Intervention Type DRUG

Placebo

Group Type PLACEBO_COMPARATOR

Placebo (Normal saline)

Intervention Type DRUG

Interventions

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G-CSF (Leucostim)

Intervention Type DRUG

CB (autologous cord blood)

Intervention Type BIOLOGICAL

Placebo (Normal saline)

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

2 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Health & Welfare, Korea

OTHER_GOV

Sponsor Role collaborator

Hanyang University Seoul Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young-Ho Lee

Professor, Department of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hanyang University Hospital

Seoul, Seoul, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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

Role: CONTACT

82-2-2290-8383

Facility Contacts

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

Role: primary

82-2-2290-8383

Other Identifiers

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CP-CB-G-2016

Identifier Type: -

Identifier Source: org_study_id

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