Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2026-01-25 @ 1:22 PM
Study NCT ID:
NCT00504803
Status:
COMPLETED
Last Update Posted:
2011-09-02
First Post:
2007-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-versus-host Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-09', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-09-01', 'studyFirstSubmitDate': '2007-07-19', 'studyFirstSubmitQcDate': '2007-07-19', 'lastUpdatePostDateStruct': {'date': '2011-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Day-100 incidence of non-relapse mortality', 'timeFrame': '100 days'}], 'secondaryOutcomes': [{'measure': '1. Hematopoietic engraftment and graft rejection. 2. Incidence of grade II-IV and III-IV acute GVHD. 3. Immunologic reconstitution', 'timeFrame': '365 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HCT, nonmyeloablative, mesenchymal stem cells, GVHD'], 'conditions': ['Hematological Malignancies']}, 'referencesModule': {'references': [{'pmid': '20109568', 'type': 'DERIVED', 'citation': 'Baron F, Lechanteur C, Willems E, Bruck F, Baudoux E, Seidel L, Vanbellinghen JF, Hafraoui K, Lejeune M, Gothot A, Fillet G, Beguin Y. Cotransplantation of mesenchymal stem cells might prevent death from graft-versus-host disease (GVHD) without abrogating graft-versus-tumor effects after HLA-mismatched allogeneic transplantation following nonmyeloablative conditioning. Biol Blood Marrow Transplant. 2010 Jun;16(6):838-47. doi: 10.1016/j.bbmt.2010.01.011. Epub 2010 Jan 28.'}]}, 'descriptionModule': {'briefSummary': 'Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning from HLA-mismatched PBSC or cord blood: a Pilot Study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "V.1. Patients\n\nV.1.1. Diseases\n\nHematological malignancies confirmed histologically and not rapidly progressing:\n\n* AML in CR;\n* ALL in CR;\n* CML unresponsive/intolerant to Imatinib but not in blast crisis;\n* Other myeloproliferative disorders not in blast crisis and not with extensive myelofibrosis;\n* MDS with \\< 5% blasts;\n* Multiple myeloma;\n* CLL;\n* Non-Hodgkin's lymphoma (aggressive NHL should have chemosensitive disease);\n* Hodgkin's disease.\n\nV.1.2. Clinical situations\n\n* Theoretical indication for a standard allo-transplant, but not feasible because:\n\n * Age \\> 55 yrs;\n * Unacceptable end organ performance;\n * Patient's refusal.\n* Indication for a standard auto-transplant: perform mini-allotransplantation 2-6 months after standard autotransplant.\n\nV.1.3. Other inclusion criteria\n\n* Male or female; fertile female patients must use a reliable contraception method;\n* Age \\< 75 yrs.\n* Informed consent given by patient or his/her guardian if of minor age.\n\nV.1.4. Exclusion criteria\n\n* Any condition not fulfilling inclusion criteria;\n* HIV positive;\n* Terminal organ failure, except for renal failure (dialysis acceptable);\n* Uncontrolled infection, arrhythmia or hypertension;\n* Previous radiation therapy precluding the use of 2 Gy TBI;\n* HLA-identical donor.\n\nV.2. PBSC donors\n\nV.2.1. Inclusion criteria\n\n* Related to the recipient (sibling, parent or child) or unrelated;\n* Male or female;\n* Weight \\> 15 Kg (because of leukapheresis);\n* Fulfills generally accepted criteria for allogeneic PBSC donation;\n* Informed consent given by donor or his/her guardian if of minor age, as per donor center standard procedures.\n\nV.2.2. Exclusion criteria\n\n* Any condition not fulfilling inclusion criteria;\n* HIV positive;\n* Unable to undergo leukapheresis because of poor vein access or other reasons.\n\nV.2.3. HLA matching\n\nRelated or unrelated donors who have 1-2 HLA mismatches, as either :\n\n* One antigenic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1\n* One allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1\n* Two allelic mismatches at HLA-A or -B or -C or -DRB1 or -DQB1\n* One antigenic mismatch + 1 allelic mismatch at HLA-A or -B or -C or -DRB1 or -DQB1.\n* One antigenic mismatch at -DQB1 and one other antigenic mismatch at HLA-A or -B or -C or -DRB1\n\nV.3. Cord blood unit\n\nBanked cord blood units will be used if they fulfill the following criteria:\n\n* No more than 2/6 HLA mismatches (antigenic mismatch at HLA-A or HLA-B or allelic mismatch at HLA-DRB1)\n* \\> 2.5 x 107 TNC/kg\n* Standard validation by FACT/Netcord criteria."}, 'identificationModule': {'nctId': 'NCT00504803', 'briefTitle': 'Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-versus-host Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Mesenchymal Stem Cell Infusion as Prevention for Graft Rejection and Graft-versus-host Disease After Allogeneic Hematopoietic Cell Transplantation With Nonmyeloablative Conditioning: a Pilot Study', 'orgStudyIdInfo': {'id': 'TJB0601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'MSC co-infusion with either HLA-mismatched PBSC or cord blood', 'interventionNames': ['Procedure: Mesenchymal stem cell infusion']}], 'interventions': [{'name': 'Mesenchymal stem cell infusion', 'type': 'PROCEDURE', 'otherNames': ['Mesenchymal stem cells'], 'description': 'Infusion of mesenchymal stem cells on the same day as hematopoietic stem cell infusion.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'state': 'Liege', 'country': 'Belgium', 'facility': 'CHU Sart Tilman', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'overallOfficials': [{'name': 'Frederic Baron, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU-ULg'}, {'name': 'Yves Beguin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU-ULg'}, {'name': 'Chantal Lechanteur, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU-ULg'}, {'name': 'Etienne Baudoux, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU-ULg'}, {'name': 'Evelyne Willems, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'CHU-ULg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof', 'investigatorFullName': 'Yves Beguin', 'investigatorAffiliation': 'University of Liege'}}}}