Trials / Unknown
UnknownNCT02866331
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 88 (estimated)
- Sponsor
- Hanyang University Seoul Hospital · Academic / Other
- Sex
- All
- Age
- 2 Years – 10 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | G-CSF (Leucostim) | |
| BIOLOGICAL | CB (autologous cord blood) | |
| DRUG | Placebo (Normal saline) |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2018-12-01
- Completion
- 2018-12-01
- First posted
- 2016-08-15
- Last updated
- 2016-08-15
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02866331. Inclusion in this directory is not an endorsement.