G-CSF and Autologous Cord Blood Infusion in Cerebral Palsy

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02866331

Enrollment

Registered

2016-08-15

Start date

2016-07-31

Completion date

2018-12-31

Last updated

2016-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Palsy

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.

Interventions

DRUGG-CSF (Leucostim)

BIOLOGICALCB (autologous cord blood)

DRUGPlacebo (Normal saline)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

2 Years to 10 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

South Korea

Contacts

Primary ContactYoung-Ho LEE, M.D., Ph.D.

cord@hanyang.ac.kr82-2-2290-8383

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026