Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-02-03 @ 2:48 AM
Study NCT ID:
NCT01941394
Status:
UNKNOWN
Last Update Posted:
2013-09-13
First Post:
2013-08-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mesenchymal Stem Cells Infusion for aGVHD Prophylaxis Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-12', 'studyFirstSubmitDate': '2013-08-30', 'studyFirstSubmitQcDate': '2013-09-12', 'lastUpdatePostDateStruct': {'date': '2013-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'GVHD', 'timeFrame': 'Every 30 day for 1 year after BMT'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Every 30 day for 1 year after BMT'}, {'measure': 'Relapse-free survival', 'timeFrame': 'Every 30 day for 1 year after BMT'}, {'measure': 'Infection rate', 'timeFrame': 'Every 30 day for 1 year after BMT'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['GVHD', 'Relapse', 'Overall Survival'], 'conditions': ['Graft-versus-host Disease', 'Relapse']}, 'referencesModule': {'references': [{'pmid': '22242033', 'type': 'RESULT', 'citation': 'Kuzmina LA, Petinati NA, Parovichnikova EN, Lubimova LS, Gribanova EO, Gaponova TV, Shipounova IN, Zhironkina OA, Bigildeev AE, Svinareva DA, Drize NJ, Savchenko VG. Multipotent Mesenchymal Stromal Cells for the Prophylaxis of Acute Graft-versus-Host Disease-A Phase II Study. Stem Cells Int. 2012;2012:968213. doi: 10.1155/2012/968213. Epub 2011 Dec 25.'}, {'pmid': '36372356', 'type': 'DERIVED', 'citation': 'Petinati N, Davydova Y, Nikiforova K, Bigildeev A, Belyavsky A, Arapidi G, Drize N, Kuzmina L, Parovichnikova E, Savchenko V. T Cell and Cytokine Dynamics in the Blood of Patients after Hematopoietic Stem Cell Transplantation and Multipotent Mesenchymal Stromal Cell Administration. Transplant Cell Ther. 2023 Feb;29(2):109.e1-109.e10. doi: 10.1016/j.jtct.2022.10.030. Epub 2022 Nov 11.'}]}, 'descriptionModule': {'briefSummary': 'Infusion of Mesenchymal Stem Cell (MSC) at day of recovery after bone marrow transplant (BMT) for patients with AL, AA and MM for acute Graft-versus-host Disease (GVHD) prophylaxis and treatment.', 'detailedDescription': 'Infusion of mesenchymal stem cells at day of recovery after BMT for patients with AL, AA and MM for acute GVHD prophylaxis and treatment. Infusion at dose 1 cells mln/kg at day of white blood cells recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* allogenic BMT from related or unrelated donor\n\nExclusion Criteria:\n\n* Severe infection\n* Relapse\n* admission to ICU\n* refusal of research\n* patients with graft failure'}, 'identificationModule': {'nctId': 'NCT01941394', 'briefTitle': 'Mesenchymal Stem Cells Infusion for aGVHD Prophylaxis Transplantation', 'organization': {'class': 'NETWORK', 'fullName': 'National Research Center for Hematology, Russia'}, 'officialTitle': 'Pilot Study for Safety and Effectiveness Assessment of Bone Marrow Mesenchymal Stem Cell Infusion for Acute Graft-versus-host Disease Prophylaxis and Treatment After Allogenic Bone Marrow Transplantation', 'orgStudyIdInfo': {'id': 'NRCH-MSC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'With MSC', 'description': 'infusion of Mesenchymal stem cells at dose 1 mln cells per kg', 'interventionNames': ['Biological: Mesenchymal stem cells']}, {'type': 'NO_INTERVENTION', 'label': 'Without MSC', 'description': 'Without MSC infusion'}], 'interventions': [{'name': 'Mesenchymal stem cells', 'type': 'BIOLOGICAL', 'otherNames': ['Mesenchymal stem cells infusion'], 'description': 'Mesenchymal stem cells infusion', 'armGroupLabels': ['With MSC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Elena Parovichnikova, Prof MD PhD', 'role': 'CONTACT', 'email': 'kuzlara@rambler.ru', 'phone': '+79161487131'}, {'name': 'Elena Parovichnikova', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'BMT department', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'centralContacts': [{'name': 'Elena Parovichnikova, Prof MD PhD', 'role': 'CONTACT', 'email': 'elenap@blood.ru', 'phone': '+79161252623'}, {'name': 'Larisa Kuzmina, MD PhD', 'role': 'CONTACT', 'email': 'kuzlara@rambler.ru', 'phone': '+79161487131'}], 'overallOfficials': [{'name': 'Elena Parovichnikova, Prof MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Research Center for Hematology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Research Center for Hematology, Russia', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of BMT department', 'investigatorFullName': 'Elena N.Parovichnikova', 'investigatorAffiliation': 'National Research Center for Hematology, Russia'}}}}