Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2026-02-20 @ 6:21 PM
Study NCT ID:
NCT02829216
Status:
UNKNOWN
Last Update Posted:
2016-07-12
First Post:
2016-05-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Graft-versus-host Disease Associated Myelosuppression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'lastUpdateSubmitDate': '2016-07-07', 'studyFirstSubmitDate': '2016-05-17', 'studyFirstSubmitQcDate': '2016-07-07', 'lastUpdatePostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the amount of mesenchymal stromal cells after allogeneic hematopoietic stem cell transplantation', 'timeFrame': 'up to 1 year after allogeneic hematopoietic stem cell transplantation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['myelosuppression', 'mesenchymal stromal cells'], 'conditions': ['Abnormal Hematopoiesis', 'Allogenic Disease', 'Graft vs Host Disease']}, 'descriptionModule': {'briefSummary': 'The objective is to measure the frequency, functionality and phenotype of bone marrow-derived mesenchymal stromal cells in patients after allogeneic hematopoietic stem cell transplantation. Furthermore, the immune cell infiltrate of the bone marrow will be monitored at the same time. These results will be correlated with the extent of cytopenia and clinical graft-versus-host disease grading.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with AML/MDS receiving an allogeneic hematopoietic stem cell transplantation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>18\n* acute myeloid leukemia\n* myelodysplastic syndrome\n* hematopoietic stem cell transplantation\n\nExclusion Criteria:\n\n* not willing to take part'}, 'identificationModule': {'nctId': 'NCT02829216', 'briefTitle': 'Graft-versus-host Disease Associated Myelosuppression', 'organization': {'class': 'OTHER', 'fullName': 'Technische Universität Dresden'}, 'officialTitle': 'Functional Profiling of the Hematopoietic Stem Cell Niche in Graft Versus Host Disease Mediated Bone Marrow Insufficiency', 'orgStudyIdInfo': {'id': 'Bone marrow GvHD'}}, 'contactsLocationsModule': {'locations': [{'zip': '01307', 'city': 'Dresden', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Malte von Bonin, MD', 'role': 'CONTACT'}], 'facility': 'Medizinische Klinik und Poliklinik I, Universitätsklinikum, TU Dresden', 'geoPoint': {'lat': 51.05089, 'lon': 13.73832}}], 'centralContacts': [{'name': 'Malte von Bonin, MD', 'role': 'CONTACT', 'email': 'malte.bonin@uniklinikum-dresden.de', 'phone': '00493514586636'}], 'overallOfficials': [{'name': 'Malte von Bonin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medizinische Klinik und Poliklinik I, Universitätsklinikum, TU Dresden'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technische Universität Dresden', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}