Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-02-13 @ 4:41 PM
Study NCT ID:
NCT02561767
Status:
UNKNOWN
Last Update Posted:
2015-09-28
First Post:
2015-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of BM-MSCs in DCD Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007683', 'term': 'Kidney Tubular Necrosis, Acute'}, {'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'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': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D020360', 'term': 'Neoadjuvant Therapy'}, {'id': 'D000077552', 'term': 'Basiliximab'}, {'id': 'D008283', 'term': 'Maintenance'}, {'id': 'C485557', 'term': 'cni protein, Drosophila'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D016559', 'term': 'Tacrolimus'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2017-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-25', 'studyFirstSubmitDate': '2015-09-25', 'studyFirstSubmitQcDate': '2015-09-25', 'lastUpdatePostDateStruct': {'date': '2015-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated glomerular filtration rate', 'timeFrame': '1 month', 'description': 'eGFR at one month post-transplant'}], 'secondaryOutcomes': [{'measure': 'Incidence of slow graft function', 'timeFrame': '12 months'}, {'measure': 'Incidence of delayed graft function', 'timeFrame': '12 months'}, {'measure': 'Proportion of normal renal function recovery', 'timeFrame': '12 months'}, {'measure': 'Time to renal function recovery', 'timeFrame': '12 months'}, {'measure': 'Patient survival', 'timeFrame': '12 months'}, {'measure': 'Renal graft survival', 'timeFrame': '12 months'}, {'measure': 'Incidence of acute rejection', 'timeFrame': '12 months'}, {'measure': 'Severe adverse events', 'timeFrame': '12 months'}, {'measure': 'Estimated glomerular filtration rate', 'timeFrame': '12 months', 'description': 'eGFR up to 12 months post-transplant'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['kidney transplantation', 'mesenchymal stem cell', "donation after citizen's death", 'ischemia reperfusion injury', 'renal function recovery'], 'conditions': ['Kidney Transplantation', 'Acute Kidney Tubular Necrosis']}, 'referencesModule': {'references': [{'pmid': '23263506', 'type': 'BACKGROUND', 'citation': 'Peng Y, Ke M, Xu L, Liu L, Chen X, Xia W, Li X, Chen Z, Ma J, Liao D, Li G, Fang J, Pan G, Xiang AP. Donor-derived mesenchymal stem cells combined with low-dose tacrolimus prevent acute rejection after renal transplantation: a clinical pilot study. Transplantation. 2013 Jan 15;95(1):161-8. doi: 10.1097/TP.0b013e3182754c53.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/23263506', 'label': 'Previous publication'}]}, 'descriptionModule': {'briefSummary': "This study is designed to determine the efficacy and safety of allogeneic bone marrow-derived mesenchymal stem cells in kidney transplantation from Chinese donation after citizen's death (DCD). A pair uremia patients receiving kidney grafts from a same donor are randomized into two groups: MSCs group and control group. Besides routine induction therapy (ATG or Basiliximab) and maintenance immunosuppressive drugs (low-dose Tacrolimus + MPA + prednisone), patients in MSCs group are administered MSCs treatment (1\\*10\\^6/kg). Allogeneic bone marrow-derived MSCs (1\\*10\\^6/kg) are given intravenously at day 0 (post renal reperfusion during surgery), day 7, day 14 and day 21. The renal allograft function, rejection, patient/graft survival and severe adverse events within 12 months post-transplant are monitored."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Primary kidney transplantation\n2. Receiving induction therapy and combined immunosuppressive regimens (CNIs + MPA + steroids)\n3. Patient is willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months\n\nExclusion Criteria:\n\n1. Secondary kidney transplantation\n2. Combined or multi-organ transplantation\n3. Women who are pregnant, intend to become pregnant in the next 1 years, breastfeeding, or have a positive pregnancy test on enrollment or prior to study medication administration\n4. Panel reactive antibody (PRA)\\>20%\n5. CDC crossmatch is positive\n6. Donors or recipients are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C\n7. Donors or recipients are known hepatitis B surface antigen-positive or PCR positive for hepatitis B\n8. Donors or recipients are known human immunodeficiency virus (HIV) infection\n9. Patients with active infection\n10. Recipients with a history of substance abuse (drugs or alcohol) within the past 6 months, or psychotic disorders that are not capable with adequate study follow-up.\n11. Patients with severe cardiovascular dysfunction\n12. WBC\\<3\\*10\\^9/L or RBC \\<5g/dL\n13. Highly allergic constitution or having severe history of allergies.\n14. Patients with active peptic ulcer disease, chronic diarrhea, or gastrointestinal problem affect absorption\n15. Patients with a history of cancer within the last 5 years\n16. Prisoner or patients compulsorily detained (involuntarily incarcerated) for treatment or either a psychiatric or physical (e.g. infectious disease) illness'}, 'identificationModule': {'nctId': 'NCT02561767', 'briefTitle': 'Effect of BM-MSCs in DCD Kidney Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'The Efficacy and Safety of Bone Marrow-derived Mesenchymal Stem Cells in Kidney Transplantation From Chinese Donation After Citizen Death (DCD): A Multi-center Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MSCs-KTx-DCD-150924'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MSCs group', 'description': 'Allogeneic bone marrow-derived mesenchymal stem cells (10\\^6/kg) from third party donors is intravenously given at day 0 (after renal artery reperfusion), day 7, day 14 and day 21.Induction therapy: ATG or Basiliximab; Maintenance therapy: low-dose Tacrolimus + mycophenolic acid + prednisone.\n\nThe third-party MSCs have no similar HLA alleles of kidney donors, and have no HLA alleles specific to preformed anti-HLA antibodies in recipients prior to KTx.', 'interventionNames': ['Other: bone marrow-derived mesenchymal stem cells', 'Drug: Induction therapy (ATG or Basiliximab)', 'Drug: Maintenance therapy (Low-dose CNI + MPA + steroids)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Placebo (saline) is intravenously given at day 0 (after renal artery reperfusion), day 7, day 14 and day 21. Induction therapy: ATG or Basiliximab; Maintenance therapy: low-dose Tacrolimus + mycophenolic acid + prednisone.', 'interventionNames': ['Other: Saline', 'Drug: Induction therapy (ATG or Basiliximab)', 'Drug: Maintenance therapy (Low-dose CNI + MPA + steroids)']}], 'interventions': [{'name': 'bone marrow-derived mesenchymal stem cells', 'type': 'OTHER', 'otherNames': ['BM-MSCs'], 'description': 'BM-MSCs is harvested from third-party health volunteer donors.', 'armGroupLabels': ['MSCs group']}, {'name': 'Saline', 'type': 'OTHER', 'description': 'Saline as placebo of MSCs', 'armGroupLabels': ['Control group']}, {'name': 'Induction therapy (ATG or Basiliximab)', 'type': 'DRUG', 'otherNames': ['ATG or Basiliximab'], 'description': 'ATG, antithymocyte globulin; Basiliximab, anti-CD25 mAb. Recipients receive ATG or Basiliximab as induction therapy in both MSCs group and control group.', 'armGroupLabels': ['Control group', 'MSCs group']}, {'name': 'Maintenance therapy (Low-dose CNI + MPA + steroids)', 'type': 'DRUG', 'otherNames': ['Low-dose tacrolimus + Mycophenolic acid (MPA) + steroids'], 'description': 'Maintenance immunosuppressive therapy consists of low-dose tacrolimus and mycophenolic acid and steroids. Recipients receive the same maintenance therapy in both MSCs group and control group.', 'armGroupLabels': ['Control group', 'MSCs group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Changxi Wang, M.D., Ph.D', 'role': 'CONTACT', 'email': 'wangchx@mail.sysu.edu.cn', 'phone': '86-20-87333428'}, {'name': 'Longshan Liu, M.D., Ph.D', 'role': 'CONTACT', 'email': 'liulshan@mail.sysu.edu.cn', 'phone': '86-20-87306082'}], 'overallOfficials': [{'name': 'Changxi Wang, M.D., Ph.D', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Second Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Organ Transplant Center', 'investigatorFullName': 'Changxi Wang', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}