Establishment of Clinical Basis for Hematopoietic Growth Factors Therapy in Brain Injury
NCT ID: NCT02018406
Last Updated: 2020-12-28
Study Results
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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RECRUITING
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2011-07-05
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intervention
Intervention Group
Combination injection of EPO and G-CSF
Subcutaneous EPO(300 U/kg)+G-CSF(10 μg/kg) injection once a day, 5 times a cycle (a week), total 3 cycles for 3 months.
Control
Control Group
Injection of normal saline
Subcutaneous normal saline injection once a day, 5 times a cycle (a week), total 3 cycles for 3 months.
Interventions
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Combination injection of EPO and G-CSF
Subcutaneous EPO(300 U/kg)+G-CSF(10 μg/kg) injection once a day, 5 times a cycle (a week), total 3 cycles for 3 months.
Injection of normal saline
Subcutaneous normal saline injection once a day, 5 times a cycle (a week), total 3 cycles for 3 months.
Eligibility Criteria
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Inclusion Criteria
* Voluntary participants
* Neurological diseases including stroke, cerebral palsy, or atypical parkinsonism, at least 3 months after their onset
* Participants who got previous EPO+GCSF injection at least 6 months ago.
Exclusion Criteria
* Participants who can not voluntarily consent
* Encephalopathy including brain tumor and infection
* Warfarin (coumadin) medications
* Leukopenia, Thrombocytopenia, Polycythemia
* Malignant diseases, Malignant hypertension, Myeloproliferative disorder, Septic embolism, Hyperkalemia
* Hepatic or Renal dysfunction, Serum creatinine\>3mg/dl
* Allergic reactions against to exogenous EPO and G-CSF
* A women who is pregnant or on breast feeding
* Body temperature over 38°C
* Blood pressure over 140/90 mmHg at pre-treatment
* Blood pressure over 160/100 mmHg during intervention
* Hb \> 15 g/dL at pre-treatment
* Hb \> 17 g/dL during intervention
* Pneumonia detected by X-ray test
* Recurrent history of aspiration pneumonia
20 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Locations
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Department of Rehabilitation Medicine, Yonsei University College of Medicine
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Sung-Rae Cho, MD
Role: primary
References
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Im SH, Yu JH, Park ES, Lee JE, Kim HO, Park KI, Kim GW, Park CI, Cho SR. Induction of striatal neurogenesis enhances functional recovery in an adult animal model of neonatal hypoxic-ischemic brain injury. Neuroscience. 2010 Aug 11;169(1):259-68. doi: 10.1016/j.neuroscience.2010.04.038.
Cho SR, Benraiss A, Chmielnicki E, Samdani A, Economides A, Goldman SA. Induction of neostriatal neurogenesis slows disease progression in a transgenic murine model of Huntington disease. J Clin Invest. 2007 Oct;117(10):2889-902. doi: 10.1172/JCI31778.
Seo JH, Kim H, Park ES, Lee JE, Kim DW, Kim HO, Im SH, Yu JH, Kim JY, Lee MY, Kim CH, Cho SR. Environmental enrichment synergistically improves functional recovery by transplanted adipose stem cells in chronic hypoxic-ischemic brain injury. Cell Transplant. 2013;22(9):1553-68. doi: 10.3727/096368912X662390. Epub 2013 Feb 4.
Other Identifiers
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4-2010-0468
Identifier Type: -
Identifier Source: org_study_id