Trial record 1 of 7 for:
Saved Studies
Neuroregenerative Potential of Intravenous G-CSF and Autologous Peripheral Blood Stem Cells
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02983708 |
|
Recruitment Status :
Completed
First Posted : December 6, 2016
Last Update Posted : December 7, 2016
|
Sponsor:
Hanyang University Seoul Hospital
Collaborator:
Ministry of Health & Welfare, Korea
Information provided by (Responsible Party):
Young-Ho Lee, Hanyang University Seoul Hospital
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief Summary:
The current study describes a randomized, double-blind, cross-over study of intravenous G-CSF followed by infusion with autologous mobilized peripheral blood mononuclear cells (mPBMCs) in children with cerebral palsy (CP) to determine the safety and feasibility of the procedure, as well as the potential efficacy for improving neurological impairment.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Neurodegeneration G-CSF Peripheral Blood Mononuclear Cells Cerebral Palsy | Biological: Peripheral blood mononuclear cells (mPBMC) Drug: G-CSF Drug: Placebo | Phase 1 Phase 2 |
We hypothesized that mobilized peripheral blood mononuclear cells (mPBMCs) would be a better source of cell therapy for children with CP, if these cells had a similar neuroregenerative potential to bone marrow/cord blood mononuclear cells (MNCs). Multipotent precursor cells exist in peripheral blood, and a fraction of elutriated blood cells from normal individuals contains MNCs that have the potential to be MSCs. There are several advantages to using mPBMCs for cell therapy in children with CP: the G-CSF that is used to mPBMCs has neuroregenerative potential; the collection and fractionation of stem cells can be repeated; and, the therapy is suitable for most children with CP.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 57 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Neuroregenerative Potential of Intravenous G-CSF and Autologous Peripheral Blood Stem Cells in Children With Cerebral Palsy: a Randomized, Double-blind Cross-over Study |
| Study Start Date : | August 2011 |
| Actual Primary Completion Date : | September 2014 |
| Actual Study Completion Date : | September 2014 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
|
Experimental: mPBMC group
G-CSF would be administered for 5 days and then mobilized peripheral blood mononuclear cells (mPBMCs) would be collected in all included patients. One month after cryopreservation of the mPBMCs (M1), patients will be randomized to receive either mPBMCs or placebo. Six months after randomization (M7), cross-over infusion of mPBMCs or placebo will be performed and the patients are observed for another 6 months. mPBMCs group would be included all patients who received mPBMCs at M1 or M7.
|
Biological: Peripheral blood mononuclear cells (mPBMC) Drug: G-CSF |
|
Placebo Comparator: Placebo group
G-CSF would be administered for 5 days and then mobilized peripheral blood mononuclear cells (mPBMCs) would be collected in all included patients. One month after cryopreservation of the mPBMCs (M1), patients will be randomized to receive either mPBMCs or placebo. Six months after randomization (M7), cross-over infusion of mPBMCs or placebo will be performed and the patients are observed for another 6 months. Placebo group would be included all patients who received placebo at M1 or M7.
|
Drug: G-CSF Drug: Placebo |
Primary Outcome Measures :
- Overall improvement as a score changes in GMFM > 4 points [ Time Frame: 6 months ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 2 Years to 10 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Non severe type of cerebral palsy
- Evidences of abnormal MRI findings such as periventricular leukomalacia
- Collected mobilized peripheral blood mononuclear cell counts > 1×10^8/kg or CD34+ cell counts > 1×10^6/kg
- Consent form
Exclusion Criteria:
- Previous trials of autologous cord blood infusion or erythropoietin/G-CSF
- Chromosomal abnormalities
No Contacts or Locations Provided
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Young-Ho Lee, Professor, Hanyang University Seoul Hospital |
| ClinicalTrials.gov Identifier: | NCT02983708 |
| Other Study ID Numbers: |
CP-PB-2011 |
| First Posted: | December 6, 2016 Key Record Dates |
| Last Update Posted: | December 7, 2016 |
| Last Verified: | December 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Plan Description: | We have to get individual permissions to make IPD available to other researchers. |
Keywords provided by Young-Ho Lee, Hanyang University Seoul Hospital:
|
Neuroregeneration G-CSF Peripheral blood mononuclear cells Cerebral palsy |
Additional relevant MeSH terms:
|
Cerebral Palsy Nerve Degeneration Nervous System Diseases Brain Damage, Chronic |
Brain Diseases Central Nervous System Diseases Pathologic Processes |