Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2026-02-26 @ 12:04 PM
Study NCT ID:
NCT02241018
Status:
UNKNOWN
Last Update Posted:
2014-09-16
First Post:
2014-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MSCs Combined With CD25 Monoclonal Antibody and Calcineurin Inhibitors for Treatment of Steroid-resistant aGVHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C584092', 'term': 'PC61 monoclonal antibody'}, {'id': 'D065095', 'term': 'Calcineurin Inhibitors'}], 'ancestors': [{'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-09-13', 'studyFirstSubmitDate': '2014-09-13', 'studyFirstSubmitQcDate': '2014-09-13', 'lastUpdatePostDateStruct': {'date': '2014-09-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The efficacy of treatment for steroid-resistant aGVHD', 'timeFrame': '1 year', 'description': 'The responses to aGVHD are according to the literature criteria, including completely response (CR), partial response (PR) and no response (NR), and CR is defined as resolution of all symptoms of aGVHD; PR is defined as a decrease by at least 1 GVHD stage in any 1 organ system without deterioration in others 24. Overall response (OR) includes CR and PR.'}], 'secondaryOutcomes': [{'measure': 'Incidence of infections', 'timeFrame': '1 year', 'description': 'Infections are mainly focused on cytomegalovirus (CMV) and Epstein-Barr virus ( EBV) infections during study treatments and within one year after study treatments.'}, {'measure': 'Incidence of primary underlying disease relapse', 'timeFrame': '1 year'}, {'measure': 'Incidence of chronic GVHD', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hematopoietic Stem Cell Transplantation', 'Mesenchymal Stem Cells', 'CD25 Monoclonal Antibody', 'Acute Graft-versus-host disease'], 'conditions': ['Acute Graft-versus-host Disease']}, 'referencesModule': {'references': [{'pmid': '15121408', 'type': 'BACKGROUND', 'citation': 'Le Blanc K, Rasmusson I, Sundberg B, Gotherstrom C, Hassan M, Uzunel M, Ringden O. Treatment of severe acute graft-versus-host disease with third party haploidentical mesenchymal stem cells. Lancet. 2004 May 1;363(9419):1439-41. doi: 10.1016/S0140-6736(04)16104-7.'}, {'pmid': '21393326', 'type': 'BACKGROUND', 'citation': 'Perez-Simon JA, Lopez-Villar O, Andreu EJ, Rifon J, Muntion S, Diez Campelo M, Sanchez-Guijo FM, Martinez C, Valcarcel D, Canizo CD. Mesenchymal stem cells expanded in vitro with human serum for the treatment of acute and chronic graft-versus-host disease: results of a phase I/II clinical trial. Haematologica. 2011 Jul;96(7):1072-6. doi: 10.3324/haematol.2010.038356. Epub 2011 Mar 10.'}, {'pmid': '40635107', 'type': 'DERIVED', 'citation': 'Zhao K, Lin R, Fan Z, Li Z, Chen X, Xuan L, Huang F, Xu N, Wu X, Chen S, Sun J, Zhang X, Weng J, Li Y, Li Y, Lin D, Nie D, Wang S, Xu X, Zhang X, Li Y, Xiang AP, Wang Y, Liu Q. Reduced morbidity and mortality of cGVHD in patients who received treatment with mesenchymal stromal cells for steroid-resistant aGVHD: long-term follow-up of a randomized phase 3 trial. Exp Hematol Oncol. 2025 Jul 9;14(1):95. doi: 10.1186/s40164-025-00687-8.'}, {'pmid': '35255929', 'type': 'DERIVED', 'citation': 'Zhao K, Lin R, Fan Z, Chen X, Wang Y, Huang F, Xu N, Zhang X, Zhang X, Xuan L, Wang S, Lin D, Deng L, Nie D, Weng J, Li Y, Zhang X, Li Y, Xiang AP, Liu Q. Mesenchymal stromal cells plus basiliximab, calcineurin inhibitor as treatment of steroid-resistant acute graft-versus-host disease: a multicenter, randomized, phase 3, open-label trial. J Hematol Oncol. 2022 Mar 7;15(1):22. doi: 10.1186/s13045-022-01240-4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the efficacy of CD25 monoclonal antibody and calcineurin inhibitors with or without mesenchymal stem cells (MSCs) in treating patients with steroid-resistant acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation.', 'detailedDescription': 'Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is an effective therapy for several hematological disorders. Although good progress has been made in the prevention and treatment of side effects associated with transplantation, aGVHDremains a common and life-threatening complication with poor prognosis. Corticosteroids are still acted as the first-line treatments of aGVHD, with a response rate of 50-80. However, those who failed to initial therapy only have 10-30% long-term survival.\n\nMesenchymal stromal cells (MSCs) are a form of multipotent adult stem cells that can be isolated from many tissues, such as bone marrow (BM), adipose tissue and umbilical cord. Such cells possess the capacity to suppress immunological responses, support hematopoiesis and repair tissues. Clinical applications of human MSCs are evolving rapidly for preventing and treating GVHD. Although the results are still controversy, most prospective and retrospective data suggest that MSCs are effective to aGVHD.\n\nIn the present study, the investigators will prospectively evaluate the efficacy and safety of ex-vivo-expanded BM-derived MSCs from third-party donors combined with CD25 monoclonal antibody and calcineurin inhibitors in treating patients with aGVHD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age of 14-65 years\n* steroid-resistant aGVHD\n* subjects (or their legally acceptable representatives) must have signed an informed consent document\n\nExclusion Criteria:\n\n* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)\n* Patients with any conditions not suitable for the trial (investigators' decision)"}, 'identificationModule': {'nctId': 'NCT02241018', 'briefTitle': 'MSCs Combined With CD25 Monoclonal Antibody and Calcineurin Inhibitors for Treatment of Steroid-resistant aGVHD', 'organization': {'class': 'OTHER', 'fullName': 'Nanfang Hospital, Southern Medical University'}, 'officialTitle': 'Mesenchymal Stem Cells Combined With CD25 Monoclonal Antibody and Calcineurin Inhibitors for Treatment of Steroid-resistant Acute Graft-versus-host Disease After Allogeneic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'NFH-MSC-aGVHD-2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mesenchymal stem cells', 'description': 'MSCs will be given at a median dose of 1×10\\^6 cells/kg once weekly for 4 dose (as 1 cycle) or until CR. The response should be evaluated at 3 and 4 weeks. If symptoms of aGVHD progress at 3 weeks or the patients have NR at 4 weeks, these patients will switch to other therapy. If patients achieved PR at 4 weeks, another cycle will be given. Besides, CD25 monoclonal antibody (20mg/kg) will be administered at day 1,4,8,15, 21 and calcineurin inhibitors will also be used.', 'interventionNames': ['Drug: CD25 monoclonal antibody', 'Drug: calcineurin inhibitors', 'Biological: MSCs']}, {'type': 'EXPERIMENTAL', 'label': 'CD25 Mc Ab & calcineurin inhibitors', 'description': 'CD25 monoclonal antibody (20mg/kg, day 1,4,8,15,21) will be administered combined with calcineurin inhibitors. The response should be evaluated at 3 and 4 weeks. If symptoms of aGVHD progress at 3 weeks or the patients have NR at 4 weeks, these patients will switch to other therapy. If patients achieved PR at 4 weeks, another cycle will be given.', 'interventionNames': ['Drug: CD25 monoclonal antibody', 'Drug: calcineurin inhibitors']}], 'interventions': [{'name': 'CD25 monoclonal antibody', 'type': 'DRUG', 'armGroupLabels': ['CD25 Mc Ab & calcineurin inhibitors', 'Mesenchymal stem cells']}, {'name': 'calcineurin inhibitors', 'type': 'DRUG', 'armGroupLabels': ['CD25 Mc Ab & calcineurin inhibitors', 'Mesenchymal stem cells']}, {'name': 'MSCs', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Mesenchymal stem cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ren Lin, MD', 'role': 'CONTACT', 'email': 'lansinglinren@hotmail.com', 'phone': '+86-020-62787883'}, {'name': 'Qifa Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Hematology,Nanfang Hospital, Southern Medical University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Ren Lin', 'role': 'CONTACT', 'email': 'lansinglinren@hotmail.com', 'phone': '+86-020-62787883'}], 'overallOfficials': [{'name': 'Qifa Liu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Nanfang Hospital, Southern Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Guangzhou General Hospital of Guangzhou Military Command', 'class': 'OTHER'}, {'name': "Guangzhou First People's Hospital", 'class': 'OTHER'}, {'name': 'Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Southern Medical University, China', 'class': 'OTHER'}, {'name': "Peking University People's Hospital", 'class': 'OTHER'}, {'name': 'Huazhong University of Science and Technology', 'class': 'OTHER'}, {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, {'name': 'Academy Military Medical Science, China', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Qifa Liu', 'investigatorAffiliation': 'Nanfang Hospital, Southern Medical University'}}}}