[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"graft-failure\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:graft-failure":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,40,80,103,137,160,183,214,236,256,279,310,328,358,382,407],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100644524","differences-in-outcomes-and-failure-rates-between-allografts-and-autografts-in-revision-anterior-cruciate-ligament-reconstruction-100644524",false,"NCT07671235","Differences in Outcomes and Failure Rates Between Allografts and Autografts in Revision Anterior Cruciate Ligament Reconstruction","ACLREV_GRAFT","Inclusion Criteria:\n\nAge 18-50 years at the time of surgery Male and female patients Patients undergoing revision anterior cruciate ligament (ACL) reconstruction with possible associated procedures, with at least 2 years of follow-up Written informed consent to participate in the study\n\nExclusion criteria:\n\nPatients lost to follow-up Refusal to provide informed consent Advanced knee osteoarthritis (Outerbridge grade III-IV) at the time of surgery Severe obesity (BMI \\> 35) Lower limb conditions preventing full weight-bearing standing during evaluation Active infection, hematologic disease, or rheumatologic disease at the time of assessment","ALL","18 Years","50 Years",{"count":20,"type":21},150,"ESTIMATED","OBSERVATIONAL","Anterior cruciate ligament (ACL) rupture is one of the most common knee injuries, particularly in young and physically active individuals. Despite advances in reconstruction techniques, graft failure and rerupture remain clinically relevant. Revision ACL surgery is more complex than primary reconstruction and is associated with inferior outcomes, with rerupture rates of approximately 13%, reaching up to 25% when both subjective and objective failure criteria are considered.\n\nThe main goal of ACL reconstruction is to restore anteroposterior and rotational knee stability, prevent secondary meniscal and cartilage damage, and enable return to sport. Surgical outcomes depend on several intraoperative factors, including graft choice and tunnel geometry, which are particularly relevant in revision settings.\n\nDiagnosis of ACL rerupture is primarily clinical, based on instability tests (Lachman, anterior drawer, pivot shift), and supported by instrumental assessment such as the KT-1000 arthrometer, which provides an objective measure of joint laxity.\n\nRevision ACL reconstruction can be performed using different surgical techniques (single-bundle, double-bundle, or combined extra-articular procedures) and graft types (autograft or allograft). Surgical strategy depends on multiple factors such as meniscal and cartilage status, previous surgery characteristics, tunnel positioning\u002Fenlargement, and fixation devices. However, no consensus exists regarding the optimal approach in terms of mid- to long-term outcomes.\n\nA major long-term complication is the development of osteoarthritis, particularly in this typically young and active patient population. Identification of modifiable factors, such as surgical technique and graft type, may help reduce failure risk and joint degeneration.\n\nThis study aims to evaluate clinical and radiographic outcomes over a follow-up period exceeding two years in patients undergoing revision ACL reconstruction with different surgical techniques and graft types. The study also integrates objective knee laxity assessment using KT-1000 and markerless motion analysis based on artificial intelligence. Functional movements are recorded via video and analyzed using Sports2D software, enabling 2D kinematic analysis without markers or sensors, providing quantitative functional data to complement clinical and radiographic evaluation.",[25,26],"ACL Injury","Graft Failure","NOT_YET_RECRUITING","2026-06-22",{"date":30,"type":31},"2026-06-26","ACTUAL",{"date":33,"type":21},"2026-07",{"date":35,"type":21},"2027-05",{"name":37,"class":38},"Stefano Zaffagnini","OTHER",1,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":53,"briefSummary":56,"conditions":57,"keywords":62,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100612320","phase-1-ruxolitinib-enhanced-haplo-hct-for-children-and-young-adults-with-sickle-cell-disease-100612320","NCT07252050","Ruxolitinib-Enhanced Haplo HCT for Children and Young Adults With Sickle Cell Disease","Ruxolitinib-Enhanced Conditioning for Pediatric and Young Adult Patients With Symptomatic Sickle Cell Disease Undergoing Haploidentical Hematopoietic Cell Transplantation","RUX-HAPLO","Inclusion Criteria:\n\n1. Participants with any genotypic form of SCD aged 12 - 45 years at enrollment with ≥1 of the following:\n\n   1. History of stroke and\u002For vasculopathy, including evidence of asymptomatic cerebrovascular disease for pediatric patients.\n   2. Recurrent moderate-severe acute chest syndrome (ACS)\n   3. Recurrent vaso-occlusive pain episodes requiring parenteral analgesia despite the institution of supportive care.\n   4. Need for chronic transfusion therapy to prevent vaso-occlusive complications (i.e. pain, stroke, and ACS).\n   5. For adult patients, an echocardiographic finding of tricuspid valve regurgitant jet velocity (TRJV) ≥ 2.7 m\u002Fsec.\n2. Participants must have an HLA haploidentical first degree relative (parent, sibling, or half sibling) who is willing and able to donate bone marrow.\n3. Participants must meet institutional eligibility criteria for HCT.\n\nExclusion Criteria:\n\n1. Presence of an HLA-matched sibling who is willing and able to donate bone marrow.\n2. Uncontrolled infection, evidence of active TB, Hepatitis B or C infection, or HIV seropositivity or infection.\n3. Previous HCT or solid organ transplant.\n4. CNS revascularization procedure, myocardial infarction, pulmonary embolus or deep vein thrombosis in the past 6 months.\n5. Use of medications which significantly interfere with ruxolitinib metabolism.\n6. Known hypersensitivity or severe reaction to ruxolitinib or any component of the conditioning regimen or its excipients.\n7. Inability to swallow and retain oral medication (use of nasogastric or gastrostomy tube permitted).\n8. History of malignancy except resected basal cell carcinoma or treated carcinoma in-situ.\n9. Participation in another clinical trial involving an investigational or off-label use of a drug or device in the past 3 months.\n10. Currently pregnant or breast feeding.\n11. Clinically significant, uncontrolled autoimmune disease.\n12. High-titer anti-donor specific HLA antibodies (without review and approval by Study Chair).\n13. Participant (or guardian) inability or unwillingness to comply with the dose schedule and study evaluations, comprehend or sign informed consent and utilize a highly effective method of contraception (for participants of child-bearing potential).\n14. Any condition that would, in the investigator's judgment, interfere with full participation in the study, pose a significant risk to the subject, or interfere with interpretation of study data.","12 Years","45 Years",{"count":51,"type":21},24,"INTERVENTIONAL",[54,55],"PHASE1","PHASE2","This trial will determine whether adding ruxolitinib to a reduced intensity conditioning (RIC) regimen reduces the rate of graft failure following haploidentical (haplo) hematopoietic cell transplant (HCT) for children and young adults with sickle cell disease (SCD).\n\nThis study will enroll and treat up to 24 participants. Recruitment is expected to last for about 2 years and participants will be followed for an additional 2 years post-HCT.",[58,59,60,61,26],"Sickle Cell Disease","Hematopoetic Stem Cell Transplant","Haploidentical Hematopoietic Stem Cell Transplant","Haploidentical Stem Cell Transplantation",[63,64,65,66,67,68],"Sickle cell disease","Hematopoietic cell transplant","Ruxolitinib","Pediatric","Young Adult","Haplo","RECRUITING","2026-06-02",{"date":72,"type":31},"2026-06-04",{"date":74,"type":21},"2026-06-08",{"date":76,"type":21},"2029-11-19",{"name":78,"class":38},"Arkansas Children's Hospital Research Institute",4,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":16,"minAge":4,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":52,"phases":91,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":39},"100583131","phase-2-allo-hsct-for-high-risk-hemoglobinopathies-100583131","NCT06872333","Allo HSCT for High Risk Hemoglobinopathies","Allogeneic Hematopoietic Stem Cell Transplant for Patients With High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders","Inclusion Criteria:\n\n* Sickle Cell Disease (SCD)\n* SCD Patients with a fully matched sibling donor (MSD) irrespective of the frequency or severity of symptoms MSD transplant can be considered. Parents\u002Fpatient must be counseled as to the risks and benefits and provide their voluntary informed consent\n* Transfusion Dependent Alpha- or Beta- Thalassemia\n* Diamond Blackfan Anemia\n* Other Non-Malignant Hematologic Disorders\n* Karnofsky ≥ 60%, Lansky play score ≥ 60. Patients with lower performance score can be considered based on study team's evaluation.\n* Sexually active persons of childbearing potential or persons with partners of childbearing potential must agree to use a highly effective form of contraception during study treatment and for at least 4 months after the transplant.\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding or intending to become pregnant during the study. Persons of childbearing potential must have a negative pregnancy test (serum or urine) within 30 days of the start of treatment\n* HIV infection with a detectable viral load. All HIV+ patients must be evaluated by infectious disease (ID) and an HIV management plan established prior to transplantation.\n* Active, uncontrolled infection - infection that is stable or improving after 1 week of appropriate therapy (4 weeks for presumed or documented fungal infections) will be permitted\n* Known allergy to any of the study components\n* Psychiatric illness\u002Fsocial situations that, in the judgement of the enrolling Investigator, would limit compliance with study requirements\n* Other illness or a medical issue that, in the judgement of the enrolling Investigator, would exclude the patient from participating in this study",true,"55 Years",{"count":90,"type":21},62,[55],"A single center, open label, interventional, phase II trial for donor transplant for high risk hemoglobinopathies and other red cell transfusion dependent disorders utilizing allogeneic hematopoietic stem cell transplantation (HSCT) regimens.",[26,58,94],"Hemoglobinopathies","2026-06-01",{"date":72,"type":31},{"date":98,"type":31},"2024-11-19",{"date":100,"type":21},"2032-06-01",{"name":102,"class":38},"Masonic Cancer Center, University of Minnesota",{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":112,"conditions":113,"keywords":117,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":39},"100577602","graft-failure-and-consequences-of-coronary-artery-bypass-graft-surgery-100577602","NCT06800430","Graft Failure and Consequences of Coronary Artery Bypass Graft Surgery","Vein Graft Failure and Cardiovascular Consequences of Coronary Artery Bypass Graft Surgery","INCLUSION CRITERIA:\n\nCohort 1: Patients undergoing CABG surgery\n\n* Males and females over 18 years of age\n* Patients undergoing CABG surgery for multivessel coronary artery disease, who receive at least one saphenous vein graft\n\nCohort 2: Patients with symptomatic saphenous vein graft vasculopathy\n\n* Males and females over 18 years of age\n* Patients who underwent CABG surgery ≥ 5 years prior to recruitment for multivessel disease and received 2 or more saphenous vein grafts\n* Referred for invasive coronary angiography due to recurrent symptoms and with a high suspicion of graft vasculopathy\n\nEXCLUSION CRITERIA:\n\n* Patients with a life expectancy of \\\u003C 2 years\n* Renal failure (estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m2)\n* Patients on immunosuppressive therapies\n* Females of child-bearing age who are pregnant or breastfeeding,\n* Known allergy or contraindications to iodinated contrast or radiotracer\n* Patients who are unable to tolerate the supine position\n* Patients who are unable to provide informed consent",{"count":111,"type":21},70,"Coronary artery bypass graft (CABG) surgery is the commonest type of heart operation performed. During this, arteries or veins (termed 'grafts') are used to supply blood around blockages within the blood vessels that supply the heart. Unfortunately, these grafts can sometimes fail, and patients can also experience complications like heart attacks and strokes, after surgery. It is known that vein grafts are more likely to narrow over time. Additionally, treating vein graft failure is very challenging, as repeat surgery is riskier and procedures to stent open the veins can also fail. However, it is not fully understood why these complications occur.\n\nIn this study, the investigators will use an imaging technique called a total-body Positron Emission Tomography (PET) scan. This uses special radioactive dyes (radiotracers) to look at what is happening inside vein grafts. With this technique, the investigators will also be able to see what is happening to the heart, brain and wider parts of the body after CABG surgery.\n\nThis study will aim to recruit 70 participants in total (maximum 150). 40 (maximum of 120) of these participants will have recently undergone CABG surgery and received ≥1 vein graft. The remaining 30 will have undergone CABG surgery ≥5 years ago and will have symptoms suggestive of vein graft failure.\n\nThe study will last a total of 36 months and will involve participants undertaking the following assessments:\n\n1. Total-body Positron Emission Tomography and Computed Tomography (PET-CT) scan\n2. Ultrasound scan of the heart (echocardiogram)\n3. A blood test - up to four tablespoons (60 mL) of blood will be taken for immediate testing and the remainder will be stored for future ethically approved studies.",[114,26,115,116],"Coronary Artery Bypass","Coronary Artery Bypass Graft","Coronary Artery Bypass Graft Surgery (CABG)",[118,119,120,121,122,123,124,125,126,127],"CABG","graft failure","coronary artery bypass","cardiovascular","heart surgery","cardiac surgery","coronary artery bypass graft","cardiovascular disease","heart disease","positron emission tomography","2026-04-15",{"date":130,"type":31},"2026-04-20",{"date":132,"type":31},"2025-03-28",{"date":134,"type":21},"2027-08-06",{"name":136,"class":38},"University of Edinburgh",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":52,"phases":146,"briefSummary":148,"conditions":149,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":39},"100611733","early-phase-1-prevention-of-graft-rejection-in-hematopoietic-stem-cell-transplant-hsct-recipients-100611733","NCT07244419","Prevention of Graft Rejection in Hematopoietic Stem Cell Transplant (HSCT) Recipients","Emapalumab for the Prevention of Graft Rejection in Hematopoietic Stem Cell Transplant (HSCT) Recipients","Inclusion Criteria:\n\n* All patients undergoing allogeneic HSCT at our institution will be evaluated for graft rejection risk factors. Patients deemed high risk for graft rejection will have 2 or more of the following: mismatched or haploidentical donor, ex vivo t-cell depleted graft, prior history of graft rejection.\n\nExclusion Criteria:\n\n* Known hypersensitivity to any constituent of the study medication.",{"count":145,"type":21},20,[147],"EARLY_PHASE1","The investigators hypothesize that graft rejection after hematopoietic stem cell transplant (HSCT) is primarily driven by interferon gamma, and prophylactic interferon gamma inhibition in high-risk patients will prevent graft rejection. Additionally, knowledge of emapalumab PK\u002FPD and in vitro mechanistic effects of emapalumab in this novel setting will guide optimization of dosing regimens and treatment approaches in future studies.",[150,26],"Hematopoietic Stem Cell Transplantation","2026-01-21",{"date":153,"type":31},"2026-01-22",{"date":155,"type":31},"2026-01-07",{"date":157,"type":21},"2029-08",{"name":159,"class":38},"Children's Hospital Medical Center, Cincinnati",{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":52,"phases":170,"briefSummary":172,"conditions":173,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":179,"leadSponsor":181,"locationsCount":39},"100577794","phase-4-pilot-trial-of-colchicine-for-graft-failure-in-cabg-100577794","NCT06802926","Pilot Trial of Colchicine for Graft Failure in CABG","A Single Center Pilot Trial of Preliminary Effect of Colchicine on Graft Failure in Patients Underwent CABG","CoCAB-Pilot","Inclusion Criteria:\n\n* Age≥18 years old，\n* Any sex，\n* Signed informed consent，\n* Within 3 days after a successful isolated CABG\n\nExclusion Criteria:\n\n* Allergy,\n* Hematopoietic dysfunction,\n* Moderate to severe hepatic dysfunction,\n* Moderate to severe renal dysfunction.",{"count":169,"type":21},100,[171],"PHASE4","The goal of this pilot trial is to to evaluate the preliminary effect of oral colchicine therapy on graft outcomes in patients underwent primary isolated CABG.\n\nThe main questions it aims to answer is:\n\n1. Whether the oral colchicine therapy may reduce the failure outcome of grafts after CABG.\n2. Whether it is feasible to construct a muticenter powered trial to test the superiority hypothesis.\n\nResearchers will compare colchicine to none to see if colchicine works.\n\nParticipants will\n\n1. Take oral colchicine (0.5mg daily) therapy for 12 months after CABG.\n2. Clinical follow-up at Month 1, 6, and 12 after CABG.\n3. Protocol-driven CCTA at Week 1 and Month 12 after CABG.",[118,26,174],"Colchicine","2025-12-29",{"date":177,"type":31},"2026-01-02",{"date":175,"type":31},{"date":180,"type":21},"2028-12",{"name":182,"class":38},"Ruijin Hospital",{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":189,"eligibilityCriteria":190,"healthyVolunteers":11,"sex":191,"minAge":17,"maxAge":192,"enrollmentInfo":193,"targetDuration":4,"studyType":52,"phases":194,"briefSummary":196,"conditions":197,"keywords":200,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":39},"100529865","one-year-patency-comparison-between-radial-artery-and-no-touch-saphenous-vein-grafts-in-women-undergoing-isolated-cabg-100529865","NCT06179329","One-year Patency Comparison Between Radial Artery and No-touch Saphenous Vein Grafts in Women Undergoing Isolated CABG","No-Touch Saphenous Venous Harvesting TechniQue versUs Radial artEry in Coronary Artery Bypass Grafting in womEN: The QUEEN Multicenter Randomized Controlled Trial","QUEEN","Inclusion Criteria:\n\nWomen aged 18 years or older and younger than 75 years, undergoing isolated and primary myocardial revascularization surgery, with triarterial coronary artery disease (three vessels involved) in vessels subject to surgical revascularization and left ventricular ejection fraction greater than 35%. The target coronary vessels of the study will be those in the territory of the left circumflex artery and the right coronary artery, which must have at least 1.5 mm in diameter, and with proximal obstructive lesions of at least 70%.\n\nExclusion Criteria:\n\n1. Preoperative conditions:\n\n   1. Lack of the patient's written informed consent.\n   2. Presence of poorly controlled diabetes, with a glycated hemoglobin value \\>8 mg\u002Fdl.\n   3. Emergency or salvage surgery, where the intervention needs to be performed quickly due to the critical clinical condition of the patient.\n   4. Renal failure with glomerular filtration rate (creatinine clearance) \\\u003C30 mL\u002Fmin.\n2. Inability to use the saphenous and\u002For radial vein\n\n   1. Positive Allen test using a pulse oximeter\n   2. Presence of abnormal flow detected by means of a Doppler exam in one of the grafts to be used.\n   3. History of vasculitis or Raynaud's syndrome, varicose veins, or history of previous saphenous vein removal\n3. Conditions that may affect patient follow-up\n\n   1. Presence of advanced peripheral arterial disease\n   2. Known contrast allergy: Presence of a documented allergy to the contrast agent used in radiological procedures.\n   3. Impossibility of tracking due to geographic inaccessibility.\n   4. Patients with lack of adherence to guidelines and\u002For prescribed medications.","FEMALE","75 Years",{"count":20,"type":21},[195],"NA","The use of a graft from the left internal thoracic artery to the left anterior descending artery has become the gold standard for the indication of coronary artery bypass grafting. However, choosing a graft for the second-best coronary artery, focusing on long-term patency, is still a challenge. The saphenous vein using the \"no-touch\" technique is an alternative to a radial artery graft, but there is little evidence, especially in women. This randomized clinical study aims to compare the patency of these grafts in the second-best coronary artery in women undergoing coronary artery bypass grafting.",[198,199,26],"Cardiac Disease","Surgery-Complications",[201,202,203,204],"Cardiovascular Surgery","Coronary Disease","Women","Graft patency","2025-12-04",{"date":207,"type":31},"2025-12-12",{"date":209,"type":31},"2024-01-01",{"date":211,"type":21},"2027-12-30",{"name":213,"class":38},"University of Sao Paulo General Hospital",{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":52,"phases":223,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":39},"100559818","cd34-selected-stem-cell-for-poor-graft-function-or-graft-failure-100559818","NCT06569082","CD34+ Selected Stem Cell for Poor Graft Function or Graft Failure","CD34+ Selected Donor Cell Boost for Management of Poor Graft Function or Primary or Secondary Graft Failure Following Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Recipient of allogeneic transplantation, adult ≥18 years, from any type of donor including matched related, matched unrelated, mismatched related or mismatched unrelated or haploidentical donor transplant.\n* Documented evidence of graft dysfunction or failure (a-c):\n\n  1. Primary graft Failure: Graft failure is defined as failure to achieve neutrophil engraftment by day +28 or lack of donor chimerism \\> 50% by day 45 not due to the underlying malignancy;\n  2. Poor graft function is defined by at least 2 of the following 3 criteria: Hemoglobin \\\u003C 8 g\u002FdL, ANC \\\u003C 0.5x109\u002FL, and platelets \\\u003C 20x109\u002FL. The cytopenia must be unexplained (such as by disease relapse) and unresponsive to hematopoietic growth factors and must last at least 4 weeks;\n  3. Secondary graft failure is defined as poor graft function associated with donor chimerism \\\u003C 5% after initial engraftment\n* Transplanted donor availability\n* Negative pregnancy test within seven (7) days of product infusion for women of childbearing potential.\n\nExclusion Criteria:\n\n* Graft failure due to disease relapse or evidence of disease relapse or progression\n* Donor unavailable or unable to collect peripheral HPC by apheresis\n* Responsive to conventional measures (such as, hematopoietic growth factor)\n* Allergic reaction to murine proteins or iron dextran\n* Women of childbearing potential with positive serum HCG",{"count":222,"type":21},21,[195],"The proposed trial is a single arm, non-randomized, single center pilot study utilizing CliniMACS CD34 Reagent System for patients following allogeneic hematopoietic stem cell transplant (HSCT) requiring treatment of graft dysfunction or failure.",[26,226],"Poor Graft Function","2025-09-23",{"date":229,"type":31},"2025-09-29",{"date":231,"type":31},"2024-10-31",{"date":233,"type":21},"2035-08",{"name":235,"class":38},"NYU Langone Health",{"id":237,"slug":238,"hasResults":11,"nctId":239,"briefTitle":240,"officialTitle":241,"acronym":4,"eligibilityCriteria":242,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":244,"conditions":245,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":39},"100445771","dd-cfdna-and-treg-in-prediction-of-kidney-transplant-acute-rejection-100445771","NCT05084768","Dd-cfDNA and Treg in Prediction of Kidney Transplant Acute Rejection","Integration of Donor-derived Cell-free DNA With HLA-DR+TNFR2+ Regulatory T Cell in the Prediction of Acute Rejection and Graft Function After Kidney Transplantation","Inclusion Criteria:\n\n* Adult kidney transplant candidates\u002Frecipients\n\nExclusion Criteria:\n\n* Age less than 18\n* Multi-organ transplants\n* Kidney transplant candidates\u002Frecipients with HIV\n* Kidney transplant candidates\u002Frecipients with HCV",{"count":20,"type":21},"Acute rejection after kidney transplantation should ideally be diagnosed prior to immunologic injury in a non-invasive fashion in order to improve long-term graft function. Donor-derived cell-free DNA (ddcfDNA) is a promising method to do so as it is elevated prior to acute rejection and has good predictive performance especially for antibody-mediated and high severity T-cell mediated rejection. Its ability to predict low severity T-cell mediated rejection and future graft function remains equivocal. Regulatory T cells (Tregs) are essential in transplant tolerance by suppressing effector immune responses. Circulating post-transplant highly suppressive HLA-DR+ Tregs were reduced in recipients who developed acute rejection. Preliminary results in a cohort including predominantly low severity T-cell mediated rejection also showed that pre-transplant circulating highly suppressive TNFR2+ Tregs were reduced in and could predict acute rejection. Integrating dd-cfDNA with HLA-DR+TNFR2+ Treg could improve the predictive performance for acute rejection especially of low severity and potentially predict graft function. Plasma dd-cfDNA and HLA-DR+TNFR2+ Tregs will be measured in 150 kidney transplant recipients at scheduled intervals during the first 6 months post-transplant. Predictive accuracy of a model integrating ddcfDNA and HLA-DR+TNFR2+ Treg for acute rejection will be tested using ROC curve analysis and multivariate logistic regression. Predictive accuracy for 1-year graft function will be tested using multivariate linear regression. High predictive performance for acute rejection and graft function using a model integrating dd-cfDNA and HLA-DR+TNFR2+ Treg would help identify kidney transplant recipients at immunologic risk early on and allow personalization of immunosuppression accordingly.",[246,26],"Acute Rejection of Renal Transplant","2025-08-06",{"date":249,"type":31},"2025-08-07",{"date":251,"type":31},"2020-12-07",{"date":253,"type":21},"2026-10-01",{"name":255,"class":38},"Loma Linda University",{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":16,"minAge":263,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":52,"phases":266,"briefSummary":267,"conditions":268,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":39},"100555473","modified-second-haplo-transplantation-for-graft-failure-100555473","NCT06512545","Modified Second Haplo-transplantation for Graft Failure","Second Haploidentical Transplantation with Modified Regimen for Graft Failure After the First Allogeneic Stem Cell Transplantation","Inclusion Criteria:\n\n* 1.Primary disease: hematological malignancies(AML, CML, MDS, lymphoma, etc.); 2.Graft failure after first allogeneic stem cell transplantation; 3.Time from the first transplantation to the second transplantation is less than 180 days; 4. Age≥14 years.\n\nExclusion Criteria:\n\n* 1\\. Active infections; 2. Active GVHD; 3. Organ dysfunction: hepatic injury (Tbil≥2ULN), renal injury (Cr≥1.5ULN), heart injury (EF%\\\u003C50% or symptomatic heart failure); 4. Eastern Cooperative Oncology Group (ECOG) score\\>2; 5. Expected life time\\\u003C30 days; 5. Patients could not cooperate; 6. Other situations that are considered inappropriate for enrollment by the investigators,","14 Years",{"count":265,"type":21},12,[195],"Graft failure is a fatal complication following allogeneic stem cell transplantation where a second transplantation is usually required for salvage. We previously reported encouraging results with a novel Flu\u002FCy regimen. However, there are still around 20% patients developed delayed platelet recovery. We designed a modified regimen to further improve the hematopoietic reconstitution after second transplantation. This prospective, single-arm study aims to investigate the safety and efficacy of this modified regimen.",[26,269],"Stem Cell Transplant Complications","2024-11-26",{"date":272,"type":31},"2024-11-29",{"date":274,"type":31},"2024-07-01",{"date":276,"type":21},"2026-06-30",{"name":278,"class":38},"Peking University People's Hospital",{"id":280,"slug":281,"hasResults":11,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":52,"phases":288,"briefSummary":289,"conditions":290,"keywords":295,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":39},"100568090","phase-4-study-to-compare-the-outcome-of-receiving-continued-immunosuppression-versus-stopping-immunosuppression-at-6-months-to-safely-prevent-human-leukocyte-antigen-hla-sensitization-in-patients-with-late-renal-graft-failure-100568090","NCT06676696","Study to Compare the Outcome of Receiving Continued Immunosuppression Versus Stopping Immunosuppression at 6 Months to Safely Prevent Human Leukocyte Antigen (HLA) Sensitization in Patients With Late Renal Graft Failure","A Multi-centre, Open, Prospective, Randomized, Parallel-group, 24-month Study to Compare the Outcome of Receiving Continued Immunosuppression Versus Stopping Immunosuppression at 6 Months to Safely Prevent Human Leukocyte Antigen (HLA) Sensitization in Patients With Late Renal Graft Failure","Inclusion Criteria:\n\n* Patient must be able to understand and provide written informed consent\n* Patients older than 18 years who had received at least one previous renal transplant\n* Patients with a retained kidney graft failed for any reason which survived at least 3 months\n* Patients on dialysis, either hemodialysis or peritoneal dialysis. Patients can be on dialysis for a maximum of 6 months at the time of randomization, as long as the patients have taken an uninterrupted immunosuppressive regimen of calcineurin inhibitors (tacrolimus or cyclosporine) and steroids since dialysis was restarted\n* Patients already relisted or candidates to relist to deceased donor kidney transplantation according to the treating physician criteria\n* Patients taking immunosuppressants tacrolimus or cyclosporine\n* cPRA at the time of randomization ≤ 90%\n\nExclusion Criteria:\n\n* Patients who have received another solid organ transplantation (liver, lung, heart or pancreas)\n* Patients waiting for a living related \u002F unrelated kidney transplant\n* Graft survival of the failed graft lower than 3 months\n* Patients in dialysis more than 6 months at the time of randomization\n* Patients not accomplishing criteria to relist in the transplantation list according to the treating physician criteria\n* Pregnant women\n* Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study. Patients should use one of the acceptable birth control measures recommended in the document \"Recommendations related to contraception and pregnancy testing in clinical trials\" published by the Clinical Trials Facilitation and Coordination Group (CTFG) (version 1.1, published 21\u002F09\u002F2020). Recommended birth control measures include oral, injected or implanted hormonal contraceptive, barrier methods (condom or diaphragm with spermicide), intrauterine device, surgical sterilization, transdermal delivery, or sexual abstinence. If sexually active, the subject must have been using one of the accepted birth control methods at least one month prior to study entry.",{"count":287,"type":21},202,[171],"The goal of this clinical trial is to compare the degree of HLA sensitization at 2 years in patients with late renal graft failure (\\> 3 months) when receiving reduced immunosuppressant treatment versus stopping immunosuppression at 6 months.\n\nThe main question this study aims to answer is:\n\nDoes maintaining long-term immunosuppression in patients with a late renal graft failure (\\> 3 months) safely reduce the risk of HLA sensitization?\n\nTo answer this question, patients will be assigned to a control arm or investigational arm:\n\n* Patients assigned to the control arm will receive standard treatment, in which immunosuppressant treatment is withdrawn after 6 months.\n* Patients assigned to the investigatonal arm will continue immunosuppressant treatment at low doses for 2 years.\n\nPatients recruited in this clinical trial will be followed for up to 2 years. During this time, patients will visit the clinic every 3 months for checkups and tests.",[291,26,292,293,294],"Renal Failure , Chronic","Graft Rejection","Allograft","Renal Failure Chronic Requiring Dialysis",[296,297,298,299,300],"Renal failure","immunosuppressor","HLA sensitization","Graft failure","Calcineurin inhibitors","2024-11-05",{"date":303,"type":31},"2024-11-06",{"date":305,"type":31},"2024-01-22",{"date":307,"type":21},"2028-01-31",{"name":309,"class":38},"Hospital Universitari Vall d'Hebron Research Institute",{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":16,"minAge":263,"maxAge":4,"enrollmentInfo":317,"targetDuration":4,"studyType":52,"phases":319,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":325,"leadSponsor":327,"locationsCount":39},"100555471","second-haplo-transplantation-for-graft-failure-100555471","NCT06512519","Second Haplo-transplantation for Graft Failure","A Multicenter Prospective Study of Second Haploidentical Transplantation for Graft Failure After the First Haploidentical Transplantation","Inclusion Criteria:\n\n* 1\\. Primary disease: hematological malignancies (AML, CML, MDS, lymphoma, etc.); 2. Graft failure after the first haploidentical stem cell transplantation; 3. Time from the first transplantation to the second transplantation is less than 180 days; 4. Age≥14 years.\n\nExclusion Criteria:\n\n* 1\\. Active infections; 2. Active GVHD; 3. Organ dysfunction: hepatic injury (Tbil≥2ULN), renal injury (Cr≥1.5ULN), heart injury (EF%\\\u003C50% or symptomatic heart failure); 4. Eastern Cooperative Oncology Group (ECOG) score\\>2; 5. Expected life time\\\u003C30 days; 5. Patients could not cooperate; 6. Other situations that are considered inappropriate for enrollment by the investigators,",{"count":318,"type":21},34,[195],"Graft failure is a fatal complication following allogeneic stem cell transplantation where a second transplantation is usually required for salvage. There are no recommended regimens for second transplantations for graft failure, especially in the haploidentical transplant setting. We recently reported encouraging outcomes using a novel method (haploidentical transplantation from a different donor after conditioning with fludarabine and cyclophosphamide). However, the study was performed in single-center and with very small sample size. Therefore, it should be further validated via multicenter study. In this multi-center study, we aim to further evaluate the safety and efficacy of this protocol.",[26,269],{"date":323,"type":31},"2024-11-07",{"date":274,"type":31},{"date":326,"type":21},"2027-06",{"name":278,"class":38},{"id":329,"slug":330,"hasResults":11,"nctId":331,"briefTitle":332,"officialTitle":333,"acronym":334,"eligibilityCriteria":335,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":336,"enrollmentInfo":337,"targetDuration":339,"studyType":22,"phases":4,"briefSummary":340,"conditions":341,"keywords":344,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":39},"100421820","prior-cabg-patients-evaluated-for-saphenous-vein-graft-dysfunction-and-progression-of-coronary-artery-disease-100421820","NCT04772768","Prior CABG Patients Evaluated for Saphenous VeIn grAft DysfUnction and Progression of Coronary arTery Disease","Patients With Prior Coronary Artery Bypass Graft Surgery Evaluated for Saphenous VeIn grAft DysfUnction and Progression of Coronary arTery Disease","VIADUCT","Inclusion Criteria:\n\n* Prior coronary artery bypass grafting\n* One or more saphenous vein grafts\n* Recurrent angina symptoms\n\nExclusion Criteria:\n\n* \\\u003C18 years of age\n* ≥ 90 years of age\n* Cardiogenic shock\n* Pregnancy\n* Failure to provide informed consent","90 Years",{"count":338,"type":21},500,"5 Years","This is a multi-center, observational cohort study including patients with prior coronary artery bypass grafting (CABG) and ≥1 saphenous vein grafts (SVG) presenting with recurrent ischemic symptoms. Objective: to investigate the clinical outcomes in patients with prior CABG evaluated for bypass graft failure and progression of native coronary artery disease (CAD). Follow-up will be collected through national registry databases, electronic medical patient records and standardized telephonic assessment at 3 and 5 years follow-up.",[342,26,343],"Recurrent Angina After Coronary Artery Bypass Graft","Coronary Artery Disease Progression",[345,346,347,348],"Coronary Artery Bypass Grafting","Recurrent angina","Saphenous vein graft dysfunction","Advanced coronary artery disease","2023-05-30",{"date":351,"type":31},"2023-06-02",{"date":353,"type":31},"2019-08-23",{"date":355,"type":21},"2029-07-23",{"name":357,"class":38},"Amsterdam UMC, location VUmc",{"id":359,"slug":360,"hasResults":11,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":366,"enrollmentInfo":367,"targetDuration":4,"studyType":52,"phases":368,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":373,"lastUpdatePostDateStruct":374,"startDateStruct":376,"completionDateStruct":378,"leadSponsor":380,"locationsCount":4},"100505005","phase-1-wharton-jelly-mesenchymal-stromal-cells-as-gvhd-prophylaxis-100505005","NCT05855707","Wharton Jelly Mesenchymal Stromal Cells as GVHD Prophylaxis","Wharton's Jelly Mesenchymal Stromal Cell (WG-MSC) Injections as GVHD Prophylaxis in Hematopoietic Allogeneic Stem Cell Transplantation With an Haplo-identical Donor : a Dose Escalation Study","HAPLO-GEL","Inclusion Criteria:\n\n* With AML\u002FALL\u002FSMD\u002FSMP or lymphoid neoplasm requiring allogeneic stem cell transplantation\n* In complete response (CR) for AML\u002FALL or CR,partial response (PR) or non pre-treated for SMD\u002FSMP and lymphoid neoplasm\n* Without a HLA matched related donor available and with identification of a haploidentical donor (brother, sister, parents, adult children or cousin)\n\nWith usual criteria for HSCT:\n\n* ECOG ≤ 2\n* No severe and uncontrolled infection\n* Cardiac function compatible with high dose of cyclophosphamide\n* Adequate organ function: ASAT and ALAT ≤ 2N, total bilirubin ≤ 1.5N, creatinine clearance ≥30ml\u002Fmin (except if those abnormalities are linked to the hematological disease)\n\n  * Requiring a RIC or non myeloablative conditioning:\n\n    (i) \\>50 years old; (ii) heavily pre-treated; (iii) Comoribidities according to Sorror et al. Blood 2005;106(8):2912-9, notamment HCT\u002FCI≥ 3 (JAMA. 2011 Nov 2;306(17):1874-83).\n  * With health insurance coverage (bénéficiaire ou ayant droit)\n  * Understand informed consent or optimal treatment and follow-up\n  * Contraception methods must be prescribed during all the duration of the research and using effective contraceptive methods during treatment and within 12 months for women of childbearing age and 6 months for men of childbearing age after the last dose of cyclophosphamide\n\nExclusion Criteria:\n\n* History of Cancer in the last 5 years\n* Uncontrolled infection: Seropositivity for HIV or HTLV-1 or active hepatitis B or C defined by a positive PCR HBV or HCV and hepatic cytolysis due to HBV\n* Uncontrolled coronary insufficiency, recent myocardial infarction \\\u003C6 month, current manifestations of heart failure, uncontrolled cardiac rhythm disorders, ventricular ejection fraction \\\u003C50%\n* Pulmonary failure with DLCO\\\u003C50%\n* Addition of immunosuppressant treatment for GVHD prophylaxis (except immunosuppressant allowed per protocol)\n* Renal failure with creatinine clearance \\\u003C50ml \u002F min\n* Pregnancy (β-HCG positive) or breast-feeding\n* Any debilitating medical or psychiatric illness which would preclude the realization of the SCT or the understanding of the protocol\n* Under protection by law (tutorship or curatorship)\n* Unwilling or unable to comply with the protocol","70 Years",{"count":265,"type":21},[54],"Despite progress in chemotherapy, targeted therapy and immunotherapy, allogeneic hematopoietic stem cell transplantation (allo-SCT) is still the only curative procedure for some hematological malignancies. The probability of finding a matched sibling donor (MSD) is estimated under the classical 30%, because of the age of patients and their relatives, and a matched unrelated donor (MUD) can take time to identify. Currently in France, 25% of the allo-SCT are performed with an haplo-identical related donor. The Baltimore group developed an approach using haploidentical related donors, RIC, T-replete bone marrow and post-transplant high dose cyclophosphamide (PTCy) in patients with advanced hematological malignancies. PTCy has shown to eradicate alloreactive donor and host T-cells, activated by respective antigens, thereby reducing the incidence of graft versus host disease (GvHD) but delaying hematopoietic recovery. Therefore, the main source of graft is peripheral blood stem cells (PBSC) mobilized by G-CSF in France. Unfortunately, with PBSC we observe a higher cumulative incidence of GvHD (around 50%) and a higher toxicity-related mortality (TRM), especially for recipients \\>50 years old. The co-transplantation of Mesenchymal Stem Cells (MSC) at the time of transplantation has previously shown a double interest in GvHD immunomodulation and hematopoiesis support. Pre-clinical studies (in mice) have shown that mesenchymal stromal cells (MSCs) from Wharton's Jelly reduce the incidence of GvHD when the infusions are weekly repeated. We propose a phase I clinical trial to find the maximum tolerated dose (MTD) of a weekly infusion of WJ-MSC administered as GvHD prophylaxis and as a support for a faster hematological reconstitution after haplo-identical allo-SCT.",[371,372,26],"Allogeneic Disease","GVHD,Acute","2023-05-04",{"date":375,"type":31},"2023-05-11",{"date":377,"type":21},"2023-09",{"date":379,"type":21},"2026-09",{"name":381,"class":38},"Central Hospital, Nancy, France",{"id":383,"slug":384,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":16,"minAge":390,"maxAge":366,"enrollmentInfo":391,"targetDuration":4,"studyType":52,"phases":393,"briefSummary":394,"conditions":395,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":4},"100448955","phase-2-haploidentical-allogeneic-hematopoietic-stem-cell-transplantation-with-post-transplant-cyclophosphamide-for-rescuing-patients-with-graft-failure-100448955","NCT05126186","Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation With Post-transplant Cyclophosphamide for Rescuing Patients With Graft Failure","Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation With Post-transplant Cyclophosphamide for Rescuing Patients With Graft Failure: a Phase II Study","HaploRescue","Inclusion Criteria:\n\n* Aged from 3 to 70 years\n* All hematological diseases\n* Suffering from primary or secondary (within the 60 days post-transplantation) graft failure after a 1st allo-SCT\n* With usual criteria for allo-SCT:\n\n  * ECOG ≤ 2\n  * No severe and uncontrolled infection\n  * Cardiac function compatible with high dose of cyclophosphamide\n  * Adequate organ function: ASAT and ALAT ≤ 2.5N, total bilirubin ≤ 2N, creatinine clearance ≥30ml \u002F min\n* With identification of a haploidentical donor (brother, sister, parents, adult children or cousin)\n* Absence of donor specific antibody (DSA) detected in the patient with a MFI ≥ 1500 (antibodies directed towards the distinct haplotype between donor and recipient)\n* With health insurance coverage (bénéficiaire ou ayant droit).\n* Understand informed consent or optimal treatment and follow-up.\n* Contraception methods must be prescribed during all the duration of the research. Women and men of childbearing age must use contraceptive methods within 12 months and 6 months after the last dose of cyclophosphamide, respectively.\n* Having signed a written informed consent (2 parents for patients aged less than 18)\n\nExclusion Criteria:\n\n* Aged\\\u003C 3 years old and \\>70 years old\n* With uncontrolled infection\n* With Seropositivity for HIV or HTLV-1 or active hepatitis B or C defined by a positive PCR HBV or HCV and associated hepatic cytolysis\n* Yellow fever vaccine within 2 months before transplantation\n* Cancer in the last 5 years (except basal cell carcinoma of the skin or \"in situ\" carcinoma of the cervix)\n* Uncontrolled coronary insufficiency, recent myocardial infarction \\\u003C6 month, current manifestations of heart failure, uncontrolled cardiac rhythm disorders, ventricular ejection fraction \\\u003C50%\n* Heart failure according to NYHA (II or more)\n* Preexisting acute hemorrhagic cystitis\n* Renal failure with creatinine clearance \\\u003C 30ml \u002F min\n* Urinary tract obstruction\n* Pregnant (β-HCG positive) or breast-feeding\n* Who have any debilitating medical or psychiatric illness, which preclude understanding the inform consent as well as optimal treatment and follow-up\n* COVID vaccination or recent COVID disease \\\u003C3 months\n* Tutorship or curatorship\n* Contraindications to treatments used during the research","3 Years",{"count":392,"type":21},35,[55],"Prognosis of patients with graft failure is dismal, and re-transplantation is the sole option for long-term survival. Currently, there is no consensus concerning therapeutic options in patients with primary or secondary (within the 60 days post-transplantation) graft failure and finding a new donor within an acceptable delay is challenging. Literature is poor on the subject while the overall survival of such patients is about 30% at 1 year. This situation thus represents today a very challenging unmet medical need.\n\nRecently, haploidentical (haplo) related donor Stem Cell Transplantation (haplo-SCT) have improved dramatically outcomes using T-cell replete grafts with administration of post-transplantation cyclophosphamide (PTCy, which targets alloreactive T cells generated early after an HLA-mismatched transplant, sparing regulatory T cells and leaving unaffected the non-dividing hematopoietic stem cells) and standard post-transplant immune suppression with a calcineurin inhibitor (CNI) and mycophenolate mofetil. Our group re-transplanted a patient who experienced two consecutive graft failures and was successfully managed through a third haplo-SCT from her son using PTCy. We then retrospectively collected and analyzed data from 26 primary graft failure patients transplanted between 2011 and 2017 in 15 centers on behalf of French Society for Stem Cell Transplantation and Cell Therapy (SFGM-TC). The study population consisted mainly of patients with primary or secondary (within the 60 days post-transplantation) graft failure who underwent haplo-SCT and received PTCy as graft-versus-host-disease prophylaxis. The 1-year overall survival was about 60% suggesting that this approach might be a valid option in this particular poor clinical situation but now need validation through a phase II multicenter, national, prospective cohort study.",[396,26,397],"Hematologic Diseases","Allogeneic Hematopoietic Stem Cell Transplantation","2021-11-08",{"date":400,"type":31},"2021-11-18",{"date":402,"type":21},"2021-12-01",{"date":404,"type":21},"2026-12-01",{"name":406,"class":38},"Assistance Publique - Hôpitaux de Paris",{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":413,"eligibilityCriteria":414,"healthyVolunteers":11,"sex":16,"minAge":415,"maxAge":4,"enrollmentInfo":416,"targetDuration":418,"studyType":22,"phases":4,"briefSummary":419,"conditions":420,"keywords":429,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":4},"100251946","european-transplant-registry-of-senior-renal-transplant-recipients-on-advagraf-100251946","NCT02558452","European Transplant Registry of Senior Renal Transplant Recipients on Advagraf","European Transplant Registry of Senior Renal Transplant Recipients Receiving Initial Immunosuppression With Tacrolimus Once Daily, Mycophenolate and Steroids","SENIOR","Inclusion Criteria:\n\n* Males or females, aged ≥65 years\n* Patients who received a renal allograft\n* Patients who are willing and able to participate in the study and from whom written informed consent has been obtained\n* Patients on an intended standard triple therapy with tacrolimus once daily (Advagraf with trough level ≥5ng\u002Fml) in combination with mycophenolate (either ≥1.0g\u002Fday MMF or ≥720mg\u002Fd EC-MPS) and Steroids (≥5mg prednisolone or equivalent)\n* Patient must have received primary or secondary renal allograft from a blood group compatible donor (either deceased or living)\n* Patients with low to standard immunological risk, who had a PRA 20% (PRA testing according to center's practice) or no known donor specific antibodies at transplantation\n\nExclusion Criteria:\n\n* Multi-organ recipients (solid organ or bone marrow)\n* More than secondary renal allograft recipients\n* Blood group A,B,O-incompatible allografts\n* Documented presence of donor specific antibodies (DSA)\n* Panel reactive antibody (PRA) \\>20% prior to transplantation (PRA testing according to center's practice)\n* Patients having received any other induction therapy than Basiliximab or depleting polyclonal antithymocyte antibodies (ATG) (e.g. OKT3, Campath)\n* Patients receiving Sirolimus, Everolimus, Azathioprine, Belatacept or Cyclophosphamide within 3 months prior to or at enrolment\n* History of alcohol or drug abuse with less than 6 months of sobriety\n* Patient with any condition that may affect absorption of immunosuppressives, (e.g. severe diarrhoea, gastrectomy, active peptic ulcer disease or clinically significant diabetic gastroenteropathy) or tacrolimus metabolism (e.g. liver cirrhosis)\n* Patient with mental dysfunction or inability to cooperate within the study\n* Patients who have been institutionalized by official or court order","65 Years",{"count":417,"type":21},1000,"10 Years","SENIOR transplant Registry European transplant registry of senior renal transplant recipients (above the age of 65 years) receiving initial immunosuppression with tacrolimus once daily, mycophenolate and steroids to investigate long term outcomes on an observational basis.",[26,421,246,422,423,424,425,426,427,428],"Death","Infections","Bone Disease","Post Transplant Diabetes Mellitus","Quality of Life","HLA Antibody Production","Cardiovascular Risk Factors","Non-HLA Antibody Production",[430,431,432],"elderly kidney transplant recipient","registry","tacrolimus once daily","2016-08-11",{"date":435,"type":21},"2016-08-12",{"date":437,"type":4},"2016-12",{"date":439,"type":21},"2028-01",{"name":441,"class":38},"Klemens Budde"]