Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2026-02-25 @ 8:12 PM
Study NCT ID:
NCT02565459
Status:
UNKNOWN
Last Update Posted:
2018-04-06
First Post:
2015-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MSC and Kidney Transplant Tolerance (Phase A)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-05', 'studyFirstSubmitDate': '2015-09-24', 'studyFirstSubmitQcDate': '2015-09-30', 'lastUpdatePostDateStruct': {'date': '2018-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse events', 'timeFrame': 'Changes from baseline through study completion, up to 12 months after transplant.', 'description': 'At each visit overall clinical condition of the patient will be evaluated and any adverse event will be recorded.'}, {'measure': 'Circulating naive and memory T cell count (CD45RA/CD45RO) (flow cytometry analysis)', 'timeFrame': 'Changes from baseline at 7, 14, 30 days after transplant and then every six months through study completion, up to 12 months after transplant.'}, {'measure': 'Circulating regulatory T cell count.', 'timeFrame': 'Changes from baseline at 7, 14, 30 days after transplant and then every six months through study completion, up to 12 months after transplant.'}, {'measure': 'T-cell function in mixed lymphocyte reaction.', 'timeFrame': 'Changes from baseline at 6 and 12 months after transplant.', 'description': 'IFNg-producing T cells (spots/300.000 cells) and CD8+ T cell-mediated cytotoxicity (percentage of specific lysis) will be measured in mixed lymphocyte reaction.'}, {'measure': 'Urinary FOXP3 mRNA expression evaluated by real time quantitative PCR', 'timeFrame': 'Changes from baseline at 6 and 12 months after transplant.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mesenchymal stromal cells', 'kidney transplantation', 'tolerance'], 'conditions': ['Chronic Renal Failure']}, 'descriptionModule': {'briefSummary': 'The general aim of the present study is to test a cell therapy with third-party ex-vivo expanded bone marrow-derived mesenchymal stromal cells (MSCs) as a strategy to induce tolerance in kidney transplant recipients with a deceased donor. MSCs will be prepared accordingly to established protocols, starting from the remnants in the bag and filter at the end of the bone marrow infusions. From these samples, MSCs will be expanded in good manufacturing practice (GMP) approved facilities and used for the present study in patients undergoing kidney transplantation.\n\nThe proposed study will be developed in two phases: i) a pilot explorative safety/biologic-mechanistic phase (Phase A), ii) a pilot efficacy phase (Phase B).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* First single kidney transplant;\n* Capable of understanding the purpose and risk of the study;\n* Written informed consent.\n\nExclusion Criteria:\n\n* PRA \\>10%;\n* Specific contraindication to MSC infusion;\n* Any clinical relevant condition that might affect study participation and/or study results;\n* Childbearing potential without effective contraception;\n* Pregnant women and nursing mothers;\n* Unwillingness or inability to follow study protocol in the investigator's opinion."}, 'identificationModule': {'nctId': 'NCT02565459', 'briefTitle': 'MSC and Kidney Transplant Tolerance (Phase A)', 'organization': {'class': 'OTHER', 'fullName': 'A.O. Ospedale Papa Giovanni XXIII'}, 'officialTitle': 'Third-party Bone Marrow-derived Mesenchymal Stromal Cells to Induce Tolerance in Recipients of Kidney Transplants From Deceased Donors (Phase A)', 'orgStudyIdInfo': {'id': 'Third-party MSC-Tx tolerance A'}, 'secondaryIdInfos': [{'id': '2015-002186-27', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mesenchymal Stromal Cells (MSC)', 'description': 'A single intravenous infusion (1-2 millions of MSCs per kilogram body weight) of ex-vivo expanded third-party (from healthy donors) MSCs will be performed in patients randomized to the MSC procedure in addition to the kidney transplantation.', 'interventionNames': ['Biological: Mesenchymal Stromal Cells']}, {'type': 'NO_INTERVENTION', 'label': 'No intervention'}], 'interventions': [{'name': 'Mesenchymal Stromal Cells', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Mesenchymal Stromal Cells (MSC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24127', 'city': 'Bergamo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Piero Ruggenenti, MD', 'role': 'CONTACT', 'email': 'pruggenenti@hpg23.it', 'phone': '0039 035 2674037'}, {'name': 'Eliana Gotti, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'U.O. Nefrologia e Dialisi', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}], 'centralContacts': [{'name': 'Norberto Perico, MD', 'role': 'CONTACT', 'email': 'norberto.perico@marionegri.it', 'phone': '0039 035 45351'}], 'overallOfficials': [{'name': 'Giuseppe Remuzzi, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'A.O. Ospedale Papa Giovanni XXIII'}, {'name': 'Norberto Perico, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Istituto Di Ricerche Farmacologiche Mario Negri'}, {'name': 'Giovanni Rota, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O. Ospedale Papa Giovanni XXIII'}, {'name': 'Federica Casiraghi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Istituto Di Ricerche Farmacologiche Mario Negri'}, {'name': 'Martino Introna, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laboratorio G. Lanzani, Bergamo, Italy'}, {'name': 'Alessandro Rambaldi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A.O. Ospedale Papa Giovanni XXIII'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Monia Lorini', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mario Negri Institute for Pharmacological Research', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'EC Secretary', 'investigatorFullName': 'Monia Lorini', 'investigatorAffiliation': 'A.O. Ospedale Papa Giovanni XXIII'}}}}