[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"immunological-tolerance\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:immunological-tolerance":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100479632","phase-1-delayed-immunological-tolerance-in-patients-with-well-functioning-pre-existing-hla-matched-kidney-transplants-100479632",false,"NCT05525507","Delayed Immunological Tolerance in Patients With Well-functioning Pre-existing HLA-matched Kidney Transplants","A Single-armed, Unblinded, Non-randomized Feasibility Study of Hematopoietic Stem Cell Infusion Following a Conditioning Regimen of Total Lymphoid Irradiation (TLI) and Anti-thymocyte Globulin (ATG) in Patients With a Pre-existing, Well-functioning HLA-matched Kidney Transplant","Recipient Inclusion Criteria:\n\n1. Males and females ages 18 years and older with a pre- existing kidney transplant from an HLA-matched living donor.\n2. Pre-existing living kidney transplant must be within 3 months to 5 years from date of scheduled HPSC infusion.\n3. No history of rejection with current HLA matched kidney transplant.\n4. Recipient is without post-transplant major complications, including de novo malignancy, active infection or rejection.\n5. Stable renal function determined per investigator discretion.\n6. Agreement to participate in the study and ability to give informed consent.\n7. Meets institutional criteria for HSPC infusion.\n8. Resides or is willing to stay within 3 hours distance from UCLA Medical Center by ground transportation for the first three to six months of the trial at the physician's discretion.\n9. No known contraindication to administration of rATG or radiation.\n10. If participant is a female of reproductive potential (i.e., no documented absence of ovaries or uterus, history of tubal ligation, or post-menopausal status) participant 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 post-transplant.\n11. Karnofsky Performance Score (KPS) ≥ 70.\n12. Adequate cardiac function defined as left ventricular ejection fraction (LVEF) ≥ 40% by MUGA (Multi Gated Acquisition) scan or echocardiogram.\n13. Adequate liver function defined as total bilirubin ≤ 1.5 times the upper limit of normal and AST\u002FALT ≤ 2.0 times the upper limit of normal.\n14. Adequate social support based on evaluation by the UCLA bone marrow and\u002For renal transplant team.\n\nRecipient Exclusion Criteria:\n\n1. Donor is identical twin.\n2. Major ABO incompatibility with donor\n3. Positive HLA Donor-Specific Antibody (DSA)\n4. History of multi-organ transplantation\n5. History of rejection with current HLA-matched kidney transplant\n6. Known allergy to rabbit proteins\n7. History of post-transplant major complications, including de novo malignancy, active\u002Fchronic infection or rejection, with the exception of low risk, early-stage malignancy with\n\n   ≥90% 5-year survival not receiving chemotherapy or immunotherapy and non-melanomatous skin cancer.\n8. History of active malignancy within the past 5 years with the exception:\n\n   1. Low risk cancer 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, and DCIS)\n9. Worsening renal functioning over preceding 3-month interval determined per investigator discretion.\n10. Pregnant (confirmed by urine or serum pregnancy test) or lactating.\n11. Leukopenia (with a white blood cell count \\\u003C 3,000\u002FµL) or thrombocytopenia (with a platelet count \\\u003C 70,000\u002FµL).\n12. EBV, CMV and BK PCR negative at time of HPSC infusion is preferred, but if they have had a history of + CMV\u002FBK PCR, it should be resolved by 3 months.\n13. Active bacterial, fungal, mycobacterial, or viral infection (including active hepatitis B and\u002For C).\n14. Seropositivity for HIV 1 or 2 by 4th generation serum antibody\u002Fantigen testing, or HTLV I or II by serum antibody testing.\n15. Renal disease with high risk of recurrence (i.e., focal segmental glomerulosclerosis).\n16. Advanced hepatic fibrosis or cirrhosis secondary to hepatitis B and\u002For C diagnosis.\n17. Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia; active extra-renal autoimmune disease requiring immunosuppression.\n18. Active extra-renal autoimmune disease requiring immunosuppression.\n19. Neuropsychiatric illness that precludes the ability to give informed consent and\u002For places the participant as high risk for non-compliance with the safety monitoring requirements of the study.\n20. May not have received other immunomodulatory agents, including but not limited to tumor necrosis factor inhibitors within six months of the study treatment. Use of corticosteroids prescribed for a time-limited indication (\\\u003C\u002F= 4 weeks) and stopped at least 4 weeks before the kidney transplant is acceptable.\n21. May not have received immunotherapy drugs such as immune checkpoint inhibitors (e.g. pembrolizumab, nivolumab, and ipilimumab), tumor necrosis factor inhibitors, rituximab, and interleukin-2 within six months of the study treatment.\n22. Current or active abuse of alcohol and\u002For drugs within last 6 months.\n23. Body Mass Index (BMI) ≥ 40.\n\nDonor Inclusion Criteria:\n\n1. HLA-matched sibling on high-resolution HLA typing who\n\n   a. is ≥18 years of age.\n2. Must meet institutional criteria for HSPC transplant donation.\n3. Medically fit to tolerate peripheral blood apheresis, including weighing ≥110 pounds, hemoglobin ≥11, white blood cell count ≥ 3,000\u002FµL, and platelets ≥ 100,000\u002FµL.\n4. Serum creatinine as expected post-kidney donation and coagulation parameter studies; or, if abnormal, the changes are not considered clinically significant.\n\nDonor exclusion criteria:\n\n1. Recipient is identical twin.\n2. Major ABO incompatibility with recipient.\n3. 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).\n4. Pregnant (confirmed by urine or serum pregnancy test) or lactating.\n5. Seropositivity for HIV 1 or 2 by 4th generation serum antibody\u002Fantigen testing, HTLV I or II by serum antibody testing\n6. Active West Nile Virus infection.\n7. Active bacterial, fungal, mycobacterial or viral infection (including active hepatitis B and\u002For C).\n8. Psychiatric, addictive, neurological, or other disorder that compromises ability to give true informed consent for participation in this study.\n9. History of active malignancy within the past 5 years with the exception:\n\n   1. Low risk cancer 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, and DCIS)\n10. No use of oral anticoagulants 2 days prior to apheresis. Note: Use of aspirin and non-steroidal anti-inflammatory drugs, for pain and inflammation management purposes, are permitted to enroll in the study, but these drugs must be stopped 7 days prior to apheresis, however subjects who are taking aspirin for its anti- platelet\u002Fanti-thrombotic effect, are excluded.",true,"ALL","18 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The study seeks to determine if patients with a pre-existing, well-functioning kidney transplant from a HLA-identical living donor can be withdrawn from immunosuppressive medications without compromising allograft function through hematopoietic stem cell (HPSC) infusion from the same donor. HPSC infusion will be preceded by a conditioning regimen of total lymphoid irradiation (TLI) and rabbit anti-thymocyte globulin (rATG).",[27,28,29,30],"End Stage Kidney Disease","Immunological Tolerance","Kidney Transplant Failure and Rejection","Chronic Kidney Diseases",[32,33,34,35,36,37],"immunological tolerance","kidney transplant","tolerance","end stage kidney disease","end stage renal disease","chronic kidney disease","RECRUITING","2025-11-21",{"date":41,"type":42},"2025-11-26","ACTUAL",{"date":44,"type":42},"2022-12-21",{"date":46,"type":21},"2026-12",{"name":48,"class":49},"University of California, Los Angeles","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":59,"minAge":18,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":71,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":5},"100554812","impact-of-uterine-immune-profiling-and-personalized-treatments-in-patients-receiving-a-single-blastocyst-a-matched-controlled-study-100554812","NCT06503952","Impact of Uterine Immune Profiling and Personalized Treatments in Patients Receiving a Single Blastocyst: a Matched Controlled Study","Impact of Uterine Immune Profiling and Personalized Treatments on Subsequent Live Birth in Patients Receiving a Single Blastocyst: a Matched Controlled Study","UTIMPROSET","For case: Uterine immune profiling followed by a Day-5 fresh SET or day-5 or Day-6 freeze-thawed SET within the nine months following the uterine immune profiling between January 2020 and June 2023.\n\nWill be excluded patients with no SET day-5, with uterine immune profiling more than nine months before, or with no matching pair For control: Blastocyst SET without uterine immune profiling within the year prior the embryo transfer matched to the case group between January 2018 on June 2023\n\n* maternal age (+\u002F-1 year) and\n* the past history of ART (same number of previous oocytes pick-up, same number of previous embryo transfer) and\n* the same type of transfer (IVF, ICSI, frozen transfer) and\n* the same category of expansion of the blastocoel (B1-B2\u002F B3-B4\u002F B5-B6).","FEMALE","41 Years",{"count":62,"type":21},340,"OBSERVATIONAL","A recent randomised controlled trial and previous large cohort studies have shown that the uterine immune environment is a crucial element in improving the performance of Assisted Reproductive therapy (ART). As previous studies mixed Day-3, Day-5, single or doble embryo transfer, the clear influence of the endometrial environment on the embryo itself and its type of transfer (fresh or freeze thawed) need further investigation.\n\nTo complement previous studies, the present matched- pair study aims to select the population who exclusively received a single Day-5 embryo transfer (SET) and benefitted of a uterine immune profiling between 1 January 2020 and 30 June 2023 before the SET Day-5.\n\nThis population will be matched to a population. who did not have uterine immune profiling in the nine months prior to the single Day 5 embryo transfer between 2018 and 2023.\n\nThe matching criteria are the maternal age (+\u002F-1 year), the past history of ART (same number of previous oocytes pick-up, same number of previous embryo transfer) and the same type of transfer (IVF, ICSI, frozen transfer) and the same category of expansion of the blastocoel (B1-B2\u002F B3-B4\u002F B5-B6).\n\nThe primary end-point is the live birth rate (LBR) following the Day 5 SET in the population who benefited from pre-SET immune profiling versus the LBR following the Day 5 SET in the pair- matched population who did not benefit from pre-SET uterine immune profiling Secondary end point are the clinical pregnancy rate and miscarriage rate per SET in the two paired populations",[66,67,68,69,28,70],"Infertility","Success Rate of Assisted Reproductive Therapy","Single Embryo Transfer","Pregnancy Outcomes","Immune System",[72,73,74,75,76,77],"infertility","success rate of assisted reproductibve therapy","Single embryo transfer","uterine immune profiling","personalized care","Live birth rate","NOT_YET_RECRUITING","2024-12-20",{"date":81,"type":42},"2024-12-27",{"date":83,"type":21},"2025-01-15",{"date":85,"type":21},"2025-05-30",{"name":87,"class":49},"Matricelab Innove"]