Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2026-03-26 @ 3:48 AM
Study NCT ID:
NCT02560220
Status:
COMPLETED
Last Update Posted:
2018-07-26
First Post:
2015-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MIC Cell Therapy for Individualized Immunosuppression in Living Donor Kidney Transplant Recipients
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-23', 'studyFirstSubmitDate': '2015-08-06', 'studyFirstSubmitQcDate': '2015-09-24', 'lastUpdatePostDateStruct': {'date': '2018-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome measure is the frequency of adverse events after intravenous administration of MICs within 30 days after transplantation.', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Cumulative incidence of infection', 'timeFrame': '30 days'}, {'measure': 'Cumulative incidence of CMV reactivation', 'timeFrame': '30 days'}, {'measure': 'Number of patients with PTLD', 'timeFrame': '30 days'}, {'measure': 'Number of patients with delayed graft function', 'timeFrame': '7 days'}, {'measure': 'Number of patients with a pos. CDC and/or ELISA crossmatch', 'timeFrame': 'day -1 before transplantation'}, {'measure': 'Number of patients with DSA', 'timeFrame': 'day -1 before transplantation and day 7 and 30 after transplantation'}, {'measure': 'Incidence of biopsy-proven cellular rejection', 'timeFrame': '30 days'}, {'measure': 'Incidence of biopsy-proven antibody-mediated rejection', 'timeFrame': '30 days'}, {'measure': 'Number of patients with stable graft function (S-creatinine < 2mg/dL)', 'timeFrame': '30 days'}, {'measure': 'Patient and graft survival', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Kidney Failure, Chronic']}, 'referencesModule': {'references': [{'pmid': '26077202', 'type': 'BACKGROUND', 'citation': 'Morath C, Schmitt A, Zeier M, Schmitt M, Sandra-Petrescu F, Opelz G, Terness P, Schaier M, Kleist C. Cell therapy for immunosuppression after kidney transplantation. Langenbecks Arch Surg. 2015 Jul;400(5):541-50. doi: 10.1007/s00423-015-1313-z. Epub 2015 Jun 17.'}, {'pmid': '25495457', 'type': 'BACKGROUND', 'citation': 'Kleist C, Sandra-Petrescu F, Jiga L, Dittmar L, Mohr E, Greil J, Mier W, Becker LE, Lang P, Opelz G, Terness P. Generation of suppressive blood cells for control of allograft rejection. Clin Sci (Lond). 2015 May;128(9):593-607. doi: 10.1042/CS20140258.'}, {'pmid': '26074415', 'type': 'BACKGROUND', 'citation': 'Dittmar L, Mohr E, Kleist C, Ehser S, Demirdizen H, Sandra-Petrescu F, Hundemer M, Opelz G, Terness P. Immunosuppressive properties of mitomycin C-incubated human myeloid blood cells (MIC) in vitro. Hum Immunol. 2015 Jul;76(7):480-7. doi: 10.1016/j.humimm.2015.06.008. Epub 2015 Jun 11.'}, {'pmid': '19017789', 'type': 'BACKGROUND', 'citation': 'Terness P, Oelert T, Ehser S, Chuang JJ, Lahdou I, Kleist C, Velten F, Hammerling GJ, Arnold B, Opelz G. Mitomycin C-treated dendritic cells inactivate autoreactive T cells: toward the development of a tolerogenic vaccine in autoimmune diseases. Proc Natl Acad Sci U S A. 2008 Nov 25;105(47):18442-7. doi: 10.1073/pnas.0807185105. Epub 2008 Nov 18.'}, {'pmid': '37483623', 'type': 'DERIVED', 'citation': 'Schaier M, Morath C, Wang L, Kleist C, Opelz G, Tran TH, Scherer S, Pham L, Ekpoom N, Susal C, Ponath G, Kalble F, Speer C, Benning L, Nusshag C, Mahler CF, Pego da Silva L, Sommerer C, Huckelhoven-Krauss A, Czock D, Mehrabi A, Schwab C, Waldherr R, Schnitzler P, Merle U, Schwenger V, Krautter M, Kemmner S, Fischereder M, Stangl M, Hauser IA, Kalsch AI, Kramer BK, Bohmig GA, Muller-Tidow C, Reiser J, Zeier M, Schmitt M, Terness P, Schmitt A, Daniel V. Five-year follow-up of a phase I trial of donor-derived modified immune cell infusion in kidney transplantation. Front Immunol. 2023 Jul 11;14:1089664. doi: 10.3389/fimmu.2023.1089664. eCollection 2023.'}, {'pmid': '36137752', 'type': 'DERIVED', 'citation': 'Morath C, Schaier M, Ibrahim E, Wang L, Kleist C, Opelz G, Susal C, Ponath G, Aly M, Alvarez CM, Kalble F, Speer C, Benning L, Nusshag C, Pego da Silva L, Sommerer C, Huckelhoven-Krauss A, Czock D, Mehrabi A, Schwab C, Waldherr R, Schnitzler P, Merle U, Tran TH, Scherer S, Bohmig GA, Muller-Tidow C, Reiser J, Zeier M, Schmitt M, Terness P, Schmitt A, Daniel V. Induction of Long-Lasting Regulatory B Lymphocytes by Modified Immune Cells in Kidney Transplant Recipients. J Am Soc Nephrol. 2023 Jan 1;34(1):160-174. doi: 10.1681/ASN.2022020210. Epub 2022 Sep 22.'}, {'pmid': '31990685', 'type': 'DERIVED', 'citation': 'Morath C, Schmitt A, Kleist C, Daniel V, Opelz G, Susal C, Ibrahim E, Kalble F, Speer C, Nusshag C, Pego da Silva L, Sommerer C, Wang L, Ni M, Huckelhoven-Krauss A, Czock D, Merle U, Mehrabi A, Sander A, Hackbusch M, Eckert C, Waldherr R, Schnitzler P, Muller-Tidow C, Hoheisel JD, Mustafa SA, Alhamdani MS, Bauer AS, Reiser J, Zeier M, Schmitt M, Schaier M, Terness P. Phase I trial of donor-derived modified immune cell infusion in kidney transplantation. J Clin Invest. 2020 May 1;130(5):2364-2376. doi: 10.1172/JCI133595.'}]}, 'descriptionModule': {'briefSummary': 'A phase- I clinical trial to determine safety and feasibilty of intravenous administration of mitomycin C-treated donor peripheral blood mononuclear cells in patients with chronic kidney disease stage KDIGO 4 or 5 (i.e. GFR 15-30 mL/min or \\< 15 mL/min) who receive a kidney transplant from a living donor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic kidney disease stage KDIGO 4 or 5\n* First kidney transplant from a living donor\n* Age ≥ 18 years\n* ABO compatible\n* CDC-PRA \\< 20%\n* No donor-specific antibodies\n* Negative CDC and ELISA crossmatch\n* Immunosuppression with cyclosporin A, EC-MPS and methylprednisolone\n* Informed consent\n* Adequate contraception (women with child bearing potential)\n\nExclusion Criteria:\n\n* Psychiatric disorder\n* Heart failure (NYHA III or IV)\n* Severe liver disease\n* Active hepatitis B or C or HIV infection\n* Active bacterial, fungal or viral disease\n* Malignancy or malignancy in the last 5 years before screening\n* Preexisting immunosuppression\n* Vaccination with a live vaccine in the last 3 months before screening\n* S/p splenectomy\n* Substance abuse\n* Pregnancy or lactation\n* Women: Child/pregnancy with the intended donor\n* Allergy against the investigational drug or part of it\n* Other diseases that prohibit participation in the study (in the opinion of the investigator)\n* Participation in an other interventional study'}, 'identificationModule': {'nctId': 'NCT02560220', 'acronym': 'TOL-1', 'briefTitle': 'MIC Cell Therapy for Individualized Immunosuppression in Living Donor Kidney Transplant Recipients', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'A Single-arm Phase-I Trial for the Determination of Safety and Feasibility of the Intravenous Administration of Mitomycin C-treated Donor Peripheral Blood Mononuclear Cells (MICs) for Individualized Immunosuppression in Living Donor Kidney Transplant Recipients (TOL-1 Study)', 'orgStudyIdInfo': {'id': 'TOL-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'Patients receive MIC cell therapy together with standard immunosuppressive therapy', 'interventionNames': ['Biological: Mitomycin C-induced peripheral blood mononuclear cells (MICs)']}], 'interventions': [{'name': 'Mitomycin C-induced peripheral blood mononuclear cells (MICs)', 'type': 'BIOLOGICAL', 'description': 'MICs are given intravenously 2 or 7 days before kidney transplantation from a living donor', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'University of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Martin Zeier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heidelberg University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'collaborators': [{'name': 'WiSP GmbH', 'class': 'OTHER'}, {'name': 'German Federal Ministry of Economics and Technology', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Martin Zeier, M. D.', 'investigatorFullName': 'Christian Morath, M.D.', 'investigatorAffiliation': 'Heidelberg University'}}}}