Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-02-27 @ 10:32 AM
Study NCT ID:
NCT00447460
Status:
UNKNOWN
Last Update Posted:
2007-03-22
First Post:
2007-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Refractory (Acute or Chronic) Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell
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': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2009-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-03-20', 'studyFirstSubmitDate': '2007-03-13', 'studyFirstSubmitQcDate': '2007-03-13', 'lastUpdatePostDateStruct': {'date': '2007-03-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-03-14', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the safety/efficacy of expanded in-vitro allogenic mesenchymal stem cell infusion in patients developing a GVHD refractory to the usual therapeutic measures after undergoing an allogeneic hematopoietic stem cell transplant.'}, {'measure': 'Efficacy will be evaluated in terms of GVHD response.'}, {'measure': 'Safety will be evaluated in terms of incidence of adverse events and toxicities related to the administration of MSC.'}], 'secondaryOutcomes': [{'measure': 'Evaluation of infectious complications after MSC infusion.'}, {'measure': 'Analyse the influence of MSC infusion on the posttransplant relapse risk of the base disease.'}, {'measure': 'Study the influence of MSC infusion on DFS and OS.'}, {'measure': 'Determine MSC grafted into the bone marrow (or in other organs).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Graft-vs-host disease (GVHD)', 'Mesenchymal stem cell (MSC)', 'Allogeneic hematopoietic stem cell transplant', 'Allotransplant', 'Allogenic', 'Refractory', 'CSM/EICH2005'], 'conditions': ['Graft-vs-Host Disease (GVHD)']}, 'referencesModule': {'references': [{'pmid': '21393326', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': 'Clinical trial based on the use of a new therapeutic strategy (MSC infusion) for the treatment of patients who have developed a GVHD refractory to the usual therapeutic measures after undergoing an allogenic hematopoietic stem cell transplant.', 'detailedDescription': 'This is a multicenter, single dose study of allogenic mesenchymal stem cell (1-2 x 10\\^6 MSC/Kg recipient´s bodyweight).\n\nMSC will be infused, by a central venous catheter, to patients diagnosed with GVHD refractory to first-line or subsequent treatment.\n\nAll patients will receive the same treatment. MSC suspension will be obtained from the bone marrow aspiration of a family donor and expanded in-vitro in a specific culture medium with autologous donor´s serum and with no animal-derived products.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with hematological malignancies who had been undergone an allogenic hematopoietic stem cell transplant and diagnosed with GVHD refractory to a usual treatment.\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* Adequate pulmonary function with no evidence of chronic obstructive or severe restrictive pulmonary disease.\n* Patients with ages between 18 and 65 years.\n* Signature of informed consent form is required to be done by patient and donor.\n\nExclusion Criteria:\n\n* Patients whose hematopathology has not been controlled by the transplant or is in progress.\n* Patients with bacterial, viral or fungal infection not being controlled with the adequate treatment.\n* Patients with an inadequate cardiac or pulmonary function.\n* Patients who, in the investigator´s point of view, are not in situation to tolerate the treatment.\n* Patients who do not have the required donor (HLA-identical sibling donor and not HLA-identical sibling donor).\n* Pregnant females or childbearing potential who are not on adequate contraceptive measures.\n* Patients \\<18 or \\>65 years.\n* Patients who do not sign the informed consent.'}, 'identificationModule': {'nctId': 'NCT00447460', 'briefTitle': 'Treatment of Refractory (Acute or Chronic) Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell', 'organization': {'class': 'OTHER', 'fullName': 'University of Salamanca'}, 'officialTitle': 'A Phase I/II Trial in Treating Patients With Graft-Versus-Host Disease by the Infusion of Expanded in-Vitro Allogenic Mesenchymal Stem Cell', 'orgStudyIdInfo': {'id': 'CSM/EICH2005'}, 'secondaryIdInfos': [{'id': 'EudraCT Number: 2005-003674-14'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Mesenchymal stem cell (MSC)', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08025', 'city': 'Barcelona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'David Varcárcel Ferrerías, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Santa Creu i Sant Pau Hospital', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Carmen Martínez Muñoz, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Clinic i Provincial Hospital', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '31080', 'city': 'Navarra', 'state': 'Pamplona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Rifón Roca, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Clinic of Navarra'}, {'zip': '37007', 'city': 'Salamanca', 'state': 'Salamanca', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Consuelo del Cañizo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'José A Pérez-Simón, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital of Salamanca', 'geoPoint': {'lat': 40.96882, 'lon': -5.66388}}], 'centralContacts': [{'name': 'Mercedes Comas, CRA', 'role': 'CONTACT', 'email': 'mercedes.comas@logitest.es', 'phone': '+(034)915545476', 'phoneExt': '29'}], 'overallOfficials': [{'name': 'Consuelo del Cañizo, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Haematology Service, University Hospital of Salamanca'}, {'name': 'José A Pérez-Simón, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haematology Service, University Hospital of Salamanca'}, {'name': 'David Varcárcel Ferrerías, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haematology Service, Santa Creu i Sant Pau Hospital, Barcelona'}, {'name': 'Carmen Martínez Muñoz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haematology Service, Clinic i Provincial Hospital, Barcelona'}, {'name': 'José Rifón Roca, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Haematology Service, University Clinic of Navarra'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Salamanca', 'class': 'OTHER'}, 'collaborators': [{'name': 'Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán', 'class': 'OTHER'}]}}}