Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-28 @ 6:50 PM
Study NCT ID:
NCT00972660
Status:
UNKNOWN
Last Update Posted:
2014-08-26
First Post:
2009-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Allogenic Mesenchymal Stem Cells to Treat Extensive Chronic Graft Versus Host Disease
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D016572', 'term': 'Cyclosporine'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}, {'id': 'D011241', 'term': 'Prednisone'}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D011244', 'term': 'Pregnadienediols'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-05', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-08-25', 'studyFirstSubmitDate': '2009-09-04', 'studyFirstSubmitQcDate': '2009-09-04', 'lastUpdatePostDateStruct': {'date': '2014-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The total Response rate defined as patients with complete and partial response.', 'timeFrame': 'Within the first 3 months (plus or minus 7 days) after randomization'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': 'Randomization until death or two years post last subject last treatment visit (or clinical cutoff)'}, {'measure': 'Events Free Survival', 'timeFrame': 'Randomization until death or two years post last subject last treatment visit (or clinical cutoff)'}, {'measure': 'The percentage of patients who can taper or discontinue the immunosuppressive agents', 'timeFrame': 'Randomization untill two years post the last subject last treatment visit (or clinical cutoff)'}, {'measure': 'Serum cytokine levels and lymphocyte subsets in patients with chronic GVHD', 'timeFrame': 'Achieve best response within the first 3 months after randomization'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mesenchymal stem cell', 'Efficacy', 'Safety'], 'conditions': ['Graft Versus Host Disease']}, 'descriptionModule': {'briefSummary': 'Study Design: Treatment, Randomized, Open Label, Parallel Assignment,Safety/Efficacy Study.\n\nThe purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSC) expanded ex-vivo infusion for the treatment of patients who have developed a newly diagnosed extensive or refractory chronic graft versus host disease (chronic GVHD) to the usual therapeutic measures.', 'detailedDescription': 'Chronic graft-versus-host disease (GVHD) is one of the main limitations to successful allogeneic hematopoietic stem cell transplantation (HSCT), and has a substantial impact not only on survival but also on the quality of life of otherwise cancer-free patients. Half of the patients undergoing a HLA-identical allografts who survive beyond 100 days may require long-term immunosuppressive treatment for extensive chronic GVHD, often for more than 2 years. More than one-third of patients with chronic GVHD do not respond to first-line therapy, which often involves combinations of corticosteroids and a calcineurin inhibitor. There is no standard second-line or salvage therapy for these patients and they have a poor outcome.\n\nMesenchymal stem cells (MSCs) are multipotent non-hematopoietic stem cells that can differentiate into various lineages and have been used to repair injured tissues. Recently, MSCs have also shown unique immunomodulatory properties ex-vivo, including inhibition of T-cell proliferation after stimulation by allo-antigens and mitogens, and prevention of the activity of cytotoxic T cells.MSCs have been used for the prophylaxis of acute GVHD and for the treatment of patients with steroid-refractory acute GVHD,but rarely have been used for extensive chronic GVHD.\n\nDevelopment of new therapeutic agents and strategies to rescue patients with extensive chronic GVHD would provide a significant benefit in an area of unmet medical need.\n\nIn this study, a single center randomized, non blinded Phase II clinical trial is proposed to study the safety and efficacy of mesenchymal stem cells (MSC) in the management of extensive chronic GVHD newly or refractory to the usual therapeutic measures.\n\nExpanded MSC will be infused at a dose of 2 million cells/kg twice a week for 2 weeks and weekly for the following two weeks (six doses totally)in patients based first-line therapy (steroid plus cyclosporin A ) or their primary immunosuppressive therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent obtained from patient and donor.\n* Any patient who has undergone allogeneic stem cell transplantation with extensive chronic GVHD.\n* Have not received additional agent for cGVHD within 3 months.\n* Expected life is more than 90 days.\n* Adequate pulmonary function with no evidence of chronic obstructive or severe restrictive pulmonary disease.\n* Adequate cardiac function with no evidence of uncontrolled high blood pressure,congestive heart failure, angina pectoris, acute myocardial infarction within 6 months prior to the process.\n\nExclusion Criteria:\n\n* Invasive fungal disease.\n* Active cytomegalovirus (CMV)/Epstein-Barr virus(EBV)/varicella disease).\n* Patient is with a history of hypersensitivity to bovine products.\n* Relapsed malignancy.'}, 'identificationModule': {'nctId': 'NCT00972660', 'briefTitle': 'Safety and Efficacy Study of Allogenic Mesenchymal Stem Cells to Treat Extensive Chronic Graft Versus Host Disease', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'A Phase II, Randomized Study to Evaluate the Safety and Efficacy of Ex-Vivo Cultured Allogenic Mesenchymal Stem Cells For the Treatment of Extensive Chronic Graft Versus Host Disease', 'orgStudyIdInfo': {'id': 'GDREC.[2009]008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Patients with newly diagnosed extensive cGVHD receive prednisone and cyclosporine or tacrolimus.\n\nPatients with refractory extensive cGVHD receive primary treatment (eg,prednisone and cyclosporine or tacrolimus, or plus mycophenolate mofetil, or methotrexate.)', 'interventionNames': ['Drug: Prednisone and cyclosporine or primary therapies']}, {'type': 'EXPERIMENTAL', 'label': 'Mesenchymal stem cell (MSC)', 'description': 'Patients with newly diagnosed extensive cGVHD receive MSC plus prednisone and cyclosporine or tacrolimus.\n\nPatients with refractory extensive cGVHD receive MSC plus their primary immunosuppressive treatment (eg. prednisone + cyclosporine or tacrolimus, or plus mycophenolate mofetil, or plus methotrexate.)', 'interventionNames': ['Biological: Mesenchymal stem cell (MSC)']}], 'interventions': [{'name': 'Mesenchymal stem cell (MSC)', 'type': 'BIOLOGICAL', 'otherNames': ['Medrol', 'Sandimmun Neoral', 'FK506,prograf', 'Cellcept', 'MTX'], 'description': 'Experimental:Mesenchymal stem cell(MSC). Patients with newly diagnosed extensive cGVHD: prednisone 1mg/kg + cyclosporine or tacrolimus and MSC 2×1,000,000 MSC/kg, IV twice a week for the first two weeks and weekly for the following two weeks(6 doses totally).\n\nRefractory extensive cGVHD: receive primary treatment (prednisone + cyclosporine or tacrolimus, or plus mycophenolate mofetil, or plus methotrexate ) and MSC2×1,000,000 MSC/kg, IV twice a week for the first two weeks and weekly for the following two weeks(6 doses totally).', 'armGroupLabels': ['Mesenchymal stem cell (MSC)']}, {'name': 'Prednisone and cyclosporine or primary therapies', 'type': 'DRUG', 'otherNames': ['Medral', 'Sandimmun Neoral', 'FK506,Prograf', 'Cellcept,MMF', 'MTX'], 'description': 'Patients with newly diagnosed extensive cGVHD: prednisone 1mg/kg + cyclosporine or tacrolimus\n\nPatients with refractory extensive cGVHD: primary treatment (eg.prednisone 1mg/kg + cyclosporine or tacrolimus,or plus mycophenolate mofetil, or methotrexate.)', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Guangdong General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Xin Du, MD.PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guangdong Provincial People's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'Sun Yat-sen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}