Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-01-01 @ 7:07 AM
Study NCT ID:
NCT04926194
Status:
COMPLETED
Last Update Posted:
2023-01-10
First Post:
2021-06-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Decidual Stromal Cells to Treat Graft-vs-Host Disease After Stem Cell Transplant for Myelodysplastic Syndrome/Myeloproliferative Neoplasm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054437', 'term': 'Myelodysplastic-Myeloproliferative Diseases'}], 'ancestors': [{'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-08', 'studyFirstSubmitDate': '2021-06-08', 'studyFirstSubmitQcDate': '2021-06-08', 'lastUpdatePostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eastern Cooperative Oncology Group Performance Status Score', 'timeFrame': '6 weeks'}, {'measure': 'Karnofsky Performance Score', 'timeFrame': '6 weeks'}, {'measure': 'Graft-Versus-Host Disease Severity', 'timeFrame': '6 weeks', 'description': 'By grade'}, {'measure': 'Aspartate Transaminase levels', 'timeFrame': '6 weeks'}, {'measure': 'Alanine aminotransferase levels', 'timeFrame': '6 weeks'}, {'measure': 'Alkaline phosphatase levels', 'timeFrame': '6 weeks'}, {'measure': 'Bilirubin levels', 'timeFrame': '6 weeks'}, {'measure': 'C-reactive protein levels', 'timeFrame': '6 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myelodysplastic/Myeloproliferative Neoplasm', 'Steroid Refractory GVHD', 'Allogeneic Hematopoietic Cell Transplant']}, 'descriptionModule': {'briefSummary': 'This is a single participant study of decidual stromal cells (DSC) for the treatment of steroid refractory graft-versus-host disease (GVHD) in a patient with myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'A single participant with myelodysplastic syndrome/myeloproliferative neoplasm located at Princess Margaret Cancer Centre who experienced steroid-refractory graft-vs-host disease after receiving an allogeneic hematopoietic cell transplant and have no standard treatment options available.'}, 'identificationModule': {'nctId': 'NCT04926194', 'acronym': 'DSC-SR', 'briefTitle': 'Decidual Stromal Cells to Treat Graft-vs-Host Disease After Stem Cell Transplant for Myelodysplastic Syndrome/Myeloproliferative Neoplasm', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Decidual Stromal Cells (DSC) in Treatment of Steroid-Refractory Graft-vs-host Disease in a Recipient of Matched Related Donor Allogeneic Hematopoietic Cell Transplant for Myelodysplastic Syndrome/Myeloproliferative Neoplasm', 'orgStudyIdInfo': {'id': 'DSC-SR'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient with MDS/MPN', 'description': "DSCs will be given 1 × 10\\^6 cells per kilogram of participant's body weight intravenously, administered once per week up to a maximum of six weeks depending on the clinical response.", 'interventionNames': ['Biological: Decidual stromal cells (DSC)']}], 'interventions': [{'name': 'Decidual stromal cells (DSC)', 'type': 'BIOLOGICAL', 'description': 'DSCs are isolated from donated human placenta and have been shown to have anti-inflammatory effects.', 'armGroupLabels': ['Patient with MDS/MPN']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Ivan Pasic, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Princess Margaret Cancer Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}