Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-01-03 @ 6:07 AM
Study NCT ID:
NCT03184935
Status:
SUSPENDED
Last Update Posted:
2025-05-14
First Post:
2017-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research for Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-MDS) in the Treatment of Myelodysplastic Syndrome (MDS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009190', 'term': 'Myelodysplastic Syndromes'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077209', 'term': 'Decitabine'}], 'ancestors': [{'id': 'D001374', 'term': 'Azacitidine'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012263', 'term': 'Ribonucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'whyStopped': 'Others', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2017-06-06', 'studyFirstSubmitQcDate': '2017-06-11', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Treatment related-adverse events counting', 'timeFrame': '16 weeks', 'description': 'patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells'}], 'secondaryOutcomes': [{'measure': 'Improvement in clinical function', 'timeFrame': '16 weeks', 'description': "According to 'Diagnostic and Curative Criteria of Hematological Diseases' 3rd edition edited by Zhang Zhinan and Shen Di, evaluate the hUC-MSCs efficacy. The result as follow:\n\n* complete remission (CR);\n* partial remission (PR);\n* stable disease (SD);\n* progressive disease (PD)"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myelodysplastic Syndromes', 'mesenchymal stem cells'], 'conditions': ['Myelodysplastic Syndromes']}, 'descriptionModule': {'briefSummary': 'The purposes of the study is to determine the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating Myelodysplastic Syndrome patients.', 'detailedDescription': 'This is a randomized, double-blind, paralleled study. 40 patients will be separated into two groups, and receive basic treatment (Decitabine). Patients in experimental group will receive hUC-MSC, while control group receive placebo (normal saline), four weeks as a course of treatment. All of the patients accept examination before treatment, including\n\n* diagnostic projects: bone marrow test, peripheral blood classification, chromosome, and MDS fusion gene test, etc.;\n* routine examination: blood, urine, and stool routine test, X-ray film in chest, electrocardiogram, etc.;\n* stem cell-based medicinal products usage, dosage, time, and course of treatment.\n\nThen, patients will accept routine examination everyday, and after treatment, investigator will follow-up for 6 months, to evaluate the security and efficacy of hUC-MSC.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MDS patients with international prostate symptom score is moderate or severe symptoms\n\nExclusion Criteria:\n\n* with serious renal function impaired\n* with other organ function abnormal: acute hepatitis B, ejection fraction \\< 40%, serum bilirubin \\> 3mg/dl, liver function tests abnormal, central nervous system disease, mental disease\n* bad physical condition (Karmofsky \\< 60%)\n* without signing informed consent form\n* under other therapy that possibly influence MSC security or efficacy\n* HIV or other serious disease infection\n* Donor: HIV, active hepatitis B/C infection, Syphilitic antibody positive\n* Donor/ participants: alcoholism, drug addicted, mental disease'}, 'identificationModule': {'nctId': 'NCT03184935', 'briefTitle': 'Research for Human Umbilical Cord Mesenchymal Stem Cells (19#iSCLife®-MDS) in the Treatment of Myelodysplastic Syndrome (MDS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sclnow Biotechnology Co., Ltd.'}, 'officialTitle': 'Research for Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Myelodysplastic Syndrome (MDS)', 'orgStudyIdInfo': {'id': 'SCLnow-IMIMH-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': 'Basic medication: Decitabine; Allogeneic umbilical cord mesenchymal stem cells.', 'interventionNames': ['Biological: Allogeneic umbilical cord mesenchymal stem cells', 'Drug: Decitabine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Basic medication: Decitabine; placebo: saline.', 'interventionNames': ['Drug: Decitabine']}], 'interventions': [{'name': 'Allogeneic umbilical cord mesenchymal stem cells', 'type': 'BIOLOGICAL', 'description': 'Experimental group receive Allogeneic umbilical cord mesenchymal stem cell，i.v (SCLnow 19#)', 'armGroupLabels': ['Experimental group']}, {'name': 'Decitabine', 'type': 'DRUG', 'description': 'Decitabine，20mg/m\\^2/d', 'armGroupLabels': ['Control group', 'Experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '010065', 'city': 'Hohhot', 'state': 'Inner Mongolia', 'country': 'China', 'facility': 'Inner Mongolia International Mongolian Hospital', 'geoPoint': {'lat': 40.81056, 'lon': 111.65222}}], 'overallOfficials': [{'name': 'Shana Chen', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Inner Mongolia International Mongolian Hospital'}, {'name': 'Lei Guo', 'role': 'STUDY_CHAIR', 'affiliation': 'China-Japan Union Hospital, Jilin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sclnow Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}