[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immune-tolerance\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immune-tolerance":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,41,64,106,135],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100406345","phase-1-kidney-and-hematopoietic-cell-transplants-using-a-regimen-to-promote-hematopoietic-cell-engraftment-100406345",false,"NCT04571203","Kidney and Hematopoietic Cell Transplants Using a Regimen to Promote Hematopoietic Cell Engraftment","Phase I Study of Combined Deceased Donor Kidney and Hematopoietic Cell Transplants Using a Regimen to Promote Hematopoietic Cell Engraftment","Inclusion Criteria:\n\nRECIPIENT INCLUSION CRITERIA:\n\n1. Patient is ≥ 18 years old, and \\\u003C65 years of age.\n2. Has End Stage Renal Disease (ESRD) and is a de novo kidney transplant candidate part Stanford standard of care.\n3. Listed with the Organ Procurement and Transplantation Network (OPTN) for deceased donor transplantation.\n4. A serotypic (Human Leucocyte Antigen) HLA match with the donor of a least 1 locus in A, B or DR.\n5. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 1 year post transplant.\n6. Females have a negative serum pregnancy test.\n7. Ability to understand and the willingness to sign a written informed consent document. Patients must have signed informed consent to participate in the trial.\n8. No known contraindication to administration of rabbit ATG or low dose irradiation.\n\nDONOR INCLUSION CRITERIA:\n\n1. Brain dead donor aged ≥ 16 and ≤ 55\n2. Organ Procurement Organization (OPO) consent for vertebral body procurement\n3. Organ Procurement Organization consent for research\n4. Projected cold ischemia time \\\u003C24 hours.\n\nExclusion Criteria:\n\nRECIPIENT EXCLUSION CRITERIA:\n\n1. Known allergy to rabbit protein.\n2. History of malignancy with the exception of non melanoma skin malignancy.\n3. Pregnant woman or nursing mother.\n4. Body weight \\>90kg or BMI \\>35.\n5. Evidence of HIV 1\u002F2 antibody (Ab), HTLV 1 and HTLV 2 Ab (Human T-Lymphotropic Virus), Hepatitis B sAg (surface antigen), Hepatitis C Ab, or positive syphilis screen.\n6. EBV (Epstein Bar Virus)Ab positive donor to EBV Ab negative recipient.\n7. Active bacterial, viral or fungal infection defined as currently taking medication for the infection.\n8. Leukopenia (white blood cell count \\\u003C 3000\u002Fmm3) or thrombocytopenia (with a platelet count \\\u003C 100,000\u002Fmm3).\n9. Psychiatric disorder(s) or psychosocial circumstance(s) which in the opinion of the Stanford Transplant team caring for this potential patient would place the patient at an unacceptable risk.\n10. Concern for alcohol or other substance abuse.\n11. Kidney disease at high risk for post transplant recurrence: aHUS (atypical hemolytic- uremic syndrome) and C3 glomerulopathy\n12. Panel reactive antibody (PRA) \\>80%.\n13. Positive donor specific antibody (DSA).\n14. Prior or combined organ transplant.\n15. Patients with \\>5 pack year smoking history, smoking within 10 years of enrollment, or first degree relative with lung cancer.\n\nDONOR EXCLUSION CRITERIA:\n\n1. History of malignancy with the exception of non melanoma skin malignancy.\n2. History of autoimmune disease.\n3. Known medical diagnosis of Zika virus infection within the prior 6 months, including post mortem screening.\n4. Serological evidence of HIV, Hepatitis B (surface antigen positive), or Hepatitis C infection.\n5. Evidence of systemic infection.\n6. Kidney Donor Profile Index (KDPI) \\> 70%.","ALL","18 Years","65 Years",{"count":20,"type":21},30,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a single arm phase 1 non randomized dose finding study for safety, feasibility and efficacy of deceased donor vertebral body (VB) marrow cell infusion and kidney transplantation.",[27],"Immune Tolerance","RECRUITING","2026-06-29",{"date":31,"type":32},"2026-07-01","ACTUAL",{"date":34,"type":32},"2022-05-06",{"date":36,"type":21},"2029-10-01",{"name":38,"class":39},"Stanford University","OTHER",2,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":53,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":63},"100331134","phase-1-delayed-blood-stem-transplantation-in-hla-matched-kidney-transplant-recipients-to-eliminate-immunosuppressive-drugs-100331134","NCT03591302","Delayed Blood Stem Transplantation in HLA Matched Kidney Transplant Recipients to Eliminate Immunosuppressive Drugs.","Total Lymphoid Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+ and T-cell Transfusion to Withdraw Immunosuppressive Drugs From Recipients of a Previous HLA Matched Living Donor Kidney Transplantation .","Inclusion Criteria:\n\n1. All consenting adults of age 18 years and older with previous HLA matched sibling living donor renal transplants who still have their HLA- matched kidney donor available, and who have no history of acute or chronic rejection.\n2. Patients who agree to participate in the study and sign an Informed Consent\n3. The HLA-matched donor meets the Stanford Bone Marrow Transplant criteria for stem cell donation, agrees to participate and has signed an Informed Consent.\n4. The pair is confirmed to be HLA-matched (2 haplo type match) as determined by the histocompatibility laboratory at Stanford.\n5. Patients who have no known contraindication to the administration of rabbit ATG or radiation\n6. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 18 months post transplant.\n\nExclusion Criteria:\n\n1. Known allergy to ATG or a known allergy to rabbit proteins.\n2. History of malignancy with the exception of non-melanoma skin malignancies.\n3. Pregnant women or nursing mothers.\n4. Serological evidence of HIV, Hepatitis B (HepBsAg+) or Hepatitis C infection.\n5. Leukopenia (with a white blood cell count \\\u003C 3000\u002Fmm3) or thrombocytopenia (platelet count \\\u003C 100,000\u002Fmm3)\n6. Previous history of acute or chronic rejection of the kidney transplant or recurrence of the original disease.\n7. Screening kidney biopsy demonstrating acute or chronic rejection, recurrence of original disease or interstitial fibrosis\u002FTubular Atrophy (IF\u002FTA) score greater than 1.",{"count":49,"type":21},25,[24],"The study will determine whether patients with functioning Human Leukocyte Antigen (HLA) matched kidney transplants for at least one year and who want to discontinue immunosuppressive drugs can be treated with Total Lymphoid Irradiation (TLI) and rabbit Anti-Thymocyte Globulin (rATG) and an HLA matched donor hematopoietic progenitor cell infusion such that their drugs are successfully withdrawn while maintaining normal renal function.",[27],[54,55],"Kidney Transplantation","Blood Stem Cell Transplantation",{"date":31,"type":32},{"date":58,"type":32},"2024-02-02",{"date":60,"type":21},"2028-10-01",{"name":62,"class":39},"Stephan Busque",1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":76,"conditions":77,"keywords":86,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":63},"100613626","phase-1-immune-tolerance-induction-after-liver-transplantation-100613626","NCT07269041","Immune Tolerance Induction After Liver Transplantation","A Phase I Feasibility Study of HSPC Infusion Following Total Lymphoid Irradiation and Anti-thymocyte Globulin in Patients With a Pre-existing, Well-functioning HLA-matched Living-donor Liver Transplant to Induce Immune Tolerance.","iTILT","Recipient Inclusion Criteria:\n\n1. Males and females ages 18 years and older with a pre-existing liver transplant from a living donor with a donor-recipient match at 6 or more out of 12 alleles across the HLA-A, -B, -C, -DR, -DQ, and -DP loci, as determined by high-resolution HLA typing.\n2. Pre-existing living-donor liver transplant must be 12 months to 20 years from date of scheduled HSPC infusion.\n3. Agreement to participate in the study and ability to give informed consent.\n4. Liver biopsy within 4 weeks of enrollment without signs of rejection.\n5. Meets institutional criteria for HSPC infusion.\n6. Resides or is willing to stay within 3 hours distance from UCLA Medical Center by ground transportation for the first three months of the trial at the physician's discretion.\n7. No known contraindication to administration of rATG or radiation therapy.\n8. If subject is a female of reproductive potential (i.e., no documented absence of ovaries or uterus, history of tubal ligation, or post-menopausal status), subject must be confirmed not pregnant by a serum or urine pregnancy test and must agree to practice a reliable form of contraception including hormonal treatments, barrier methods or intrauterine device for at least 12 months following initiation of the tolerance protocol.\n\nRecipient Exclusion Criteria:\n\n1. Major ABO incompatibility with donor.\n2. Any of the following labs \\> 2.0 times the upper limit of normal on screening: AST, ALT, ALP, GGT or TBil.\n3. History of rejection with current HLA-matched liver transplant within the last year.\n4. History of GVHD following liver transplant.\n5. Positive Class II HLA Donor-Specific Antibody (DSA) or class I DSA specificity above 5,000 MFI at the time of the stem cell infusion.\n6. History of multi-organ transplantation, either simultaneous or as separate events.\n7. History of more than one liver transplant.\n8. Known allergy to rabbit proteins.\n9. History of a major post-transplant complication at investigator discretion.\n10. History of active malignancy within the past 5 years except for:\n\n    1. Malignancy that has not required treatment in the past on active surveillance.\n    2. Malignancy treated with curative intent with no known active disease \\>2 years before the first dose of study treatment and of low potential risk for recurrence.\n    3. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n    4. Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ, DCIS).\n11. Active bacterial, fungal or mycobacterial infection.\n12. Clinically significant viremia from EBV, CMV, HCV or HBV PCR test within the past 3 months.\n\n    1. Significant CMV viremia is defined as greater than or equal to 137 IU\u002FmL.\n    2. If CMV low-level viremia is detected, defined as 137 - 1,000 IU\u002FmL, patients may undergo subsequent testing up to twice per week and two consecutive negative results will allow for inclusion.\n13. Seropositivity for HIV 1 or 2 by 4th generation serum antibody\u002Fantigen testing, or HTLV I or II by serum antibody testing.\n14. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.\n15. Active extra-hepatic autoimmune disease requiring immunosuppression.\n16. Autoimmune disease was the indication for liver transplantation.\n17. Any condition that precludes the ability to give informed consent and\u002For places the subject at high risk for non-compliance with the safety monitoring requirements of the study.\n18. Received immunotherapy drugs, such as immune checkpoint inhibitors (e.g. pembrolizumab, nivolumab, and ipilimumab), tumor necrosis factor inhibitors, rituximab, or interleukin-2 within six months of the study treatment.\n19. Use of medications with known hepatotoxicity or potential to confound interpretation of liver function tests (e.g., methotrexate, isoniazid, amiodarone), unless reviewed and approved by the Principal Investigator and hepatology, and the subject has demonstrated stable liver function tests for ≥6 months while on the medication.\n20. Active hepatobiliary and pancreatic diseases:\n\n    1. History of chronic hepatobiliary or pancreatic disorders that may interfere with safety assessments or interpretation of protocol endpoints, including but not limited to primary sclerosing cholangitis (PSC), autoimmune hepatitis, primary biliary cholangitis (PBC), chronic pancreatitis, recurrent cholangitis, biliary strictures, biliary obstruction, untreated bile duct injury, hepatobiliary malignancy, or metabolic\u002Fgenetic liver disease (e.g., Wilson's disease, alpha-1 antitrypsin deficiency).\n    2. Active chronic liver diseases such as metabolic dysfunction-associated steatohepatitis (MASH) and alcohol-associated liver disease.\n    3. Gallbladder diseases such as cholecystitis or symptomatic cholelithiasis.\n\nDonor Inclusion Criteria:\n\n1. Males and females ages 18 years and older meeting the HLA-matching requirements specified in the \"Recipient Inclusion Criteria\" above.\n2. Must meet the following criteria for HSPC donation:\n\n   1. Hgb: \\> 11 g\u002Fdl\n   2. Plt: \\> 80,000\u002FµL\n   3. WBC: \\> 3,000\u002FµL\n\nDonor exclusion criteria:\n\n1. Major ABO incompatibility with recipient.\n2. Medically unfit to tolerate peripheral blood apheresis (e.g., small body size, poor vascular access, not a suitable candidate for placement of a central catheter).\n3. Pregnant (confirmed by urine or serum pregnancy test) or lactating.\n4. Seropositivity for HIV 1 or 2 by 4th generation serum antibody\u002Fantigen testing, HTLV I or II by serum antibody testing.\n5. Active West Nile Virus infection.\n6. Active bacterial, fungal, mycobacterial or viral infection (including active hepatitis B and\u002For C).\n7. Psychiatric, addictive, neurological, or other disorder that compromises ability to give true informed consent for participation in this study\n8. Use of oral anticoagulants within two days of apheresis.\n9. History of active malignancy within the past 5 years except for:\n\n   1. Malignancy that has not required treatment in the past on active surveillance.\n   2. Malignancy treated with curative intent with no known active disease \\>2 years before the first dose of study treatment and of low potential risk for recurrence.\n   3. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n   4. Adequately treated carcinoma in situ without evidence of disease (e.g., cervical cancer in situ, DCIS).",{"count":73,"type":21},12,[24,75],"PHASE2","This clinical trial is being conducted to help liver transplant recipients safely discontinue toxic immunosuppressive drugs years after surgery. Lifelong use of these drugs is the current standard, but they come with life-threatening side effects. UCLA has pioneered this \"Delayed Tolerance\" approach, achieving success in numerous kidney recipients now living drug-free. The process uses a conditioning regimen followed by donor stem cell infusion to retrain the immune system to accept the liver as \"self.\"",[78,27,79,80,81,82,83,84,85],"Liver Transplantation","Immune Tolerance\u002FDrug Effects","Graft Survival","Hematopoietic Stem Cell","Chimerism","Immunosuppression After Liver Transplantation","Immunosuppression Disorders","End Stage Liver Disease",[78,27,87,82,88,89,90,91,92,93,94,95,96],"Hematopoietic Stem Cell Infusion","Mixed Chimerism","Total Lymphoid Irradiation","Antithymocyte Globulin","Immunosuppression Withdrawal","Living Donor Liver Transplant","Tolerance Induction","Delayed Immune Tolerance","Retroactive Immune Tolerance","Immunosuppression Toxicity","2026-03-10",{"date":99,"type":32},"2026-03-12",{"date":101,"type":32},"2026-02-20",{"date":103,"type":21},"2033-01",{"name":105,"class":39},"University of California, Los Angeles",{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":112,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":116,"conditions":117,"keywords":120,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":63},"100615806","mechanisms-of-maternal-immune-tolerance-in-early-pregnancy-100615806","NCT07297394","Mechanisms of Maternal Immune Tolerance in Early Pregnancy","Inclusion Criteria:\n\nBlood from patients will be included before and during pregnancies (or failed implantation) conceived through IVF\u002FICSI (Intracytoplasmic Sperm Injection) treatment and in case of miscarriage.\n\n1. where the patient (pregnant person) was ≥ 18 years of age.\n2. where the patient (pregnant person) signed a written informed consent.\n\nExclusion Criteria:\n\n1. Certain maternal infections (HIV, Hepatitis B, Hepatitis C, Syphilis)\n2. Patients under immunosuppressive medications (at time of blood sample collection)","FEMALE",{"count":114,"type":21},100,"OBSERVATIONAL","This study explores the mechanisms of maternal immune tolerance in early pregnancy by characterizing immune cell profiles and functional pathways during the first trimester. The goal is to identify immunological factors that support healthy gestation and prevent complications such as miscarriages.",[118,27,119],"Pregnancy","In Vitro Fertilization",[121,122,123,124,125],"Maternal Immune Tolerance","Early Pregnancy","Immune Regulation","T cells","Cytokines","2026-03-03",{"date":128,"type":32},"2026-03-04",{"date":130,"type":32},"2026-03-02",{"date":132,"type":21},"2030-12",{"name":134,"class":39},"University Hospital, Basel, Switzerland",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":141,"maxAge":4,"enrollmentInfo":142,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":146,"conditions":147,"keywords":150,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":63},"100527408","efficacy-and-safety-of-immunosuppressive-withdrawal-after-pediatric-liver-transplantation-100527408","NCT06147375","Efficacy and Safety of Immunosuppressive Withdrawal After Pediatric Liver Transplantation","Inclusion Criteria:\n\n* Age at liver transplantation: under 6 years\n* Follow-up time after liver transplantation: more than 4 years\n* Liver function maintains normal before enrollment\n* Monotherapy of IS (Tacrolimus or Cyclosporine A)\n* Liver biopsy: No signs of acute rejection or chronic rejection, and no obvious fibrosis (Ishak\\\u003C2) 2 years before enrollment\n* Female recipients of fertility treatment must have a negative pregnancy test before enrollment\n* No Hepatitis virus infection 1 year before enrollment\n* Written consents are required\n\nExclusion Criteria:\n\n* Original disease before liver transplantation: Tumor, secondary liver transplantation, hepatitis virus infection, autoimmune hepatitis\n* Type of liver transplantation: ABO incompatible liver transplantation or multiple organ transplantation\n* Liver biopsy: obvious fibrosis(Ishak≥2；LAFSc moderate or severe)\n* Recipients taking IS for other diseases besides their liver transplantation","4 Years",{"count":143,"type":21},47,[145],"NA","The goal of this clinical trial is to learn about the efficacy and safety of immunosuppressive withdrawal in pediatric liver transplant recipients. The main question it aims to answer is:exploring the landscape of immune tolerance after pediatric liver transplantation. Moreover,this clinical trial aims to provide important foundation and clinical data for inducing immune tolerance, as well as to clarify the mechanism of immune tolerance development in pediatric liver transplantation, identify biomarkers that can be used to predict immune tolerance, and build a prediction model of immune tolerance after pediatric liver transplantation.\n\nThe study planned to enroll 47 recipients after pediatric liver transplantation which would gradually withdrawal immunosuppressive after enrollment, divided the participants into immune tolerance and immune intolerance groups based on the outcome of immunosuppressive withdrawal.In this study, we collect the peripheral blood and liver biopsy samples from the two groups, find biomarkers with predictive value for immune tolerance in recipients after pediatric liver transplantation, and build a predictive model of immune tolerance by machine learning.",[27,148,149],"Immunosuppression","Liver Transplant; Complications",[27,151,148],"Pediatric liver transplant","NOT_YET_RECRUITING","2023-11-23",{"date":155,"type":32},"2023-11-27",{"date":157,"type":21},"2023-12-01",{"date":159,"type":21},"2028-12",{"name":161,"class":39},"Wei Gao"]