Ignite Creation Date:
2025-12-26 @ 5:21 PM
Ignite Modification Date:
2026-01-22 @ 8:46 AM
Study NCT ID:
NCT02018406
Status:
RECRUITING
Last Update Posted:
2020-12-28
First Post:
2013-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishment of Clinical Basis for Hematopoietic Growth Factors Therapy in Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D000083302', 'term': 'Hemorrhagic Stroke'}, {'id': 'D002547', 'term': 'Cerebral Palsy'}, {'id': 'C566823', 'term': 'Parkinson Disease, Familial, Type 1'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001925', 'term': 'Brain Damage, Chronic'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016179', 'term': 'Granulocyte Colony-Stimulating Factor'}], 'ancestors': [{'id': 'D003115', 'term': 'Colony-Stimulating Factors'}, {'id': 'D006023', 'term': 'Glycoproteins'}, {'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D016298', 'term': 'Hematopoietic Cell Growth Factors'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-12-23', 'studyFirstSubmitDate': '2013-10-30', 'studyFirstSubmitQcDate': '2013-12-16', 'lastUpdatePostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vital Sign', 'timeFrame': '5th day, 30th day during a cycle, and 6 months after pretest', 'description': '(1) Value of Systolic and Diastolic Blood Pressure, (2) Value of Pulse Rate, (3) Value of Respiratory Rate, (4) Value of Body Temperature.\n\nVital Sign is tested to confirm the safety of the combination of EPO and G-CSF.'}, {'measure': 'Hematological Test', 'timeFrame': '5th day, 30th day during a cycle, and 6 months after pretest', 'description': '(1) Value of Complete Blood Cells at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (2) Value of Reticulocyte at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (3) Value of Erythrocyte Sedimentation Rate at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (4) Value of C-Reactive Protein at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (5) Value of Electrolyte and Routine Chemistry at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest, (6) Value of Prothrombin Time and Activated Partial Thromboplastin Time at pre-treatment, 5th day, 30th day during a cycle (total three cycles), and 6 months after pretest.\n\nHematological Test is tested to confirm the safety of the combination of EPO and G-CSF.'}, {'measure': 'Chest and Heart Evaluation', 'timeFrame': 'at pre-treatment and 6 months after pretest', 'description': '(1) Chest X-ray finding at pre-treatment and 6 months after pretest, (2) Electrocardiography finding at pre-treatment and 6 months after pretest.\n\nChest and Heart Evaluation is tested to confirm the safety of the combination of EPO and G-CSF.'}], 'secondaryOutcomes': [{'measure': 'Hematological Test', 'timeFrame': '5th day, 30th day during a cycle, and 6 months after pretest', 'description': '(1) Value of Erythropoietin Level, (2) Value of CD34+ cells.\n\nValue of Erythropoietin Level and CD 34+ Cells are tested to demonstrate the hematological changes and effectiveness of the combination of EPO and G-CSF.'}, {'measure': 'Physical Assessment', 'timeFrame': 'at pre-treatment, 3 months, and 6 months after pretest', 'description': '(1) Score of Muscle Strength with Manual Muscle Testing, (2) Score of Joint Mobility with Range of Motion Test, (3) Score of Muscle Spasticity with Modified Ashworth Scale.\n\nPhysical Assessment is tested to identify functional recovery of patients by neurotrophic and neuroprotective effects of the combination of EPO and G-CSF.'}, {'measure': 'Occupational Assessment', 'timeFrame': 'at pre-treatment, 3 months, and 6 months after pretest', 'description': 'Score of Activities of Daily Living with Modified Barthel Index, Functional Independence Measure.\n\nOccupational Assessments is tested to identify functional recovery of patients by neurotrophic and neuroprotective effects of the combination of EPO and G-CSF.'}, {'measure': 'Psychological Assessment', 'timeFrame': 'at pre-treatment and 6 months after pretest', 'description': 'Score of Psychological Status with Mini-Mental Status Examination, Memory Quotient, Geriatric Depression Scale, if necessary\n\nPsychological Assessments are tested to identify functional recovery of patients by neurotrophic and neuroprotective effects of the combination of EPO and G-CSF.'}, {'measure': 'Verbal Assessment', 'timeFrame': 'at pre-treatment and 6 months after pretest', 'description': 'Score of Verbal Function with Aphasia Quotient, Boston Naming Test, Multi-dimensional Voice Performance, if necessary.\n\nVerbal Assessments are tested to identify functional recovery of patients by neurotrophic and neuroprotective effects of the combination of EPO and G-CSF.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hematopoietic Growth Factors (EPO, G-CSF),', 'Neurological Diseases,', 'Neurorehabilitation,', 'Neurotrophic and Neuroprotective Effects'], 'conditions': ['Neurological Diseases', 'Ischemic Stroke', 'Hemorrhagic Stroke', 'Cerebral Palsy', 'Atypical Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '20610036', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '17885687', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23394350', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of our study is to determine the safety and efficacy of the combination of erythropoietin (EPO) and granulocyte-colony stimulating factors (G-CSF) in patients with neurological diseases. To be specific, our clinical study is expected that the combination injection of EPO and G-CSF shows neurotrophic and neuroprotective effects by facilitating endogenous repair process in patients with neurological diseases including stroke, cerebral palsy, or atypical parkinsonism. Therefore, we will apply our original treatment technique in patients with neurological diseases, which is expected to overcome current ethical and technical limitations of less evidenced functional recovery, hematological changes, and side effects. Eventually, We will establish a comprehensive clinical background about neurotrophic and neuroprotective effects of this hematopoietic growth factors therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 20 years old\n* Voluntary participants\n* Neurological diseases including stroke, cerebral palsy, or atypical parkinsonism, at least 3 months after their onset\n* Participants who got previous EPO+GCSF injection at least 6 months ago.\n\nExclusion Criteria:\n\n* Under 20 years old\n* Participants who can not voluntarily consent\n* Encephalopathy including brain tumor and infection\n* Warfarin (coumadin) medications\n* Leukopenia, Thrombocytopenia, Polycythemia\n* Malignant diseases, Malignant hypertension, Myeloproliferative disorder, Septic embolism, Hyperkalemia\n* Hepatic or Renal dysfunction, Serum creatinine\\>3mg/dl\n* Allergic reactions against to exogenous EPO and G-CSF\n* Involved in a exclusion criteria for MRI test\n* A women who is pregnant or on breast feeding\n* Body temperature over 38°C\n* Blood pressure over 140/90 mmHg at pre-treatment\n* Blood pressure over 160/100 mmHg during intervention\n* Hb \\> 15 g/dL at pre-treatment\n* Hb \\> 17 g/dL during intervention\n* Pneumonia detected by X-ray test\n* Recurrent history of aspiration pneumonia'}, 'identificationModule': {'nctId': 'NCT02018406', 'briefTitle': 'Establishment of Clinical Basis for Hematopoietic Growth Factors Therapy in Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Yonsei University'}, 'orgStudyIdInfo': {'id': '4-2010-0468'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Intervention Group', 'interventionNames': ['Drug: Combination injection of EPO and G-CSF']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Control Group', 'interventionNames': ['Drug: Injection of normal saline']}], 'interventions': [{'name': 'Combination injection of EPO and G-CSF', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Intervention']}, {'name': 'Injection of normal saline', 'type': 'DRUG', 'description': 'Subcutaneous normal saline injection once a day, 5 times a cycle (a week), total 3 cycles for 3 months.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '120-752', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sung-Rae Cho, MD', 'role': 'CONTACT', 'email': 'srcho918@yuhs.ac', 'phone': '82-2-2228-3715'}], 'facility': 'Department of Rehabilitation Medicine, Yonsei University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Sung-Rae Cho, MD', 'role': 'CONTACT', 'email': 'srcho918@yuhs.ac', 'phone': '82-2-2228-3715'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yonsei University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}