[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"xenotransplantation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:xenotransplantation":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,49,72],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100610221","phase-1-study-to-evaluate-the-safety-and-efficacy-of-the-ggta1-ko-thymokidney-in-patients-with-esrd-100610221",false,"NCT07224763","Study to Evaluate the Safety and Efficacy of the GGTA1 KO Thymokidney in Patients With ESRD","EXTEND: A Prospective Study to Evaluate the Safety and Efficacy of GGTA1 KO Thymokidney XenoTransplantation in Patients With End-stage Renal Disease (ESRD)","EXTEND","Inclusion Criteria for all Participants (Groups 1 and 2):\n\n1. Provide voluntarily informed consent to participate in the study and for lifetime follow-up.\n2. Have a diagnosis of ESRD at the time of informed consent.\n3. Hemodialysis dependent for a minimum of 6 months and has a functioning arterial-venous fistula\u002Fgraft or permanent catheter at the time of informed consent.\n4. 50 to 70 years of age at the time of informed consent, or 40 to \\\u003C50 years of age with a calculated panel reactive antibody (cPRA) of ≥99.9%.\n5. Evidence of thymic involution on chest computed tomography (CT) scan with a thymic region of interest score of ≤1.\n6. Live within 3 hours travel time of the xenotransplant center.\n7. Female participants must be postmenopausal or permanently sterilized (eg, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy). Male participants must agree to the use of a highly effective method of birth control, if the possibility of conception exists.\n8. Negative xeno-crossmatch at Screening and pre-transplant.\n9. Estimated Post Transplant Survival Calculator score \\>20%.(https:\u002F\u002Foptn.transplant.hrsa.gov\u002Fdata\u002Fallocation-calculators\u002Fepts-calculator\u002F).\n10. Body mass index ≤35 kg\u002Fm2.\n11. Have completed or have initiated and plan to complete (meningococcal A, C, W, Y and meningococcal B vaccine series only) Centers for Disease Control and Prevention-recommended courses of age- and risk-factor-appropriate vaccinations.\n12. Seropositive (immunoglobulin G) for cytomegalovirus and Epstein-Barr virus.\n\nAdditional Inclusion Criteria for Group 1:\n\n1\\. Ineligible for conventional allogeneic kidney transplantation due to medical reason(s) for any of the following:\n\n1. Ineligible for a living donor transplant.\n2. Ineligible for an OPTN kidney transplant waitlist (reason for ineligibility will be collected).\n3. Delisted from OPTN kidney transplant waitlist (reason for delisting will be collected).\n\nAdditional Inclusion Criteria for Group 2:\n\n1. On an OPTN kidney transplant waitlist (active or inactive status).\n2. No approved living kidney donors.\n3. More likely to die or go untransplanted within 5 years than receive a kidney transplant as measured by the Kidney Transplant Decision Aid at the time of informed consent (select United States for \"Choose your state\" field and National average for \"Choose your transplant program\" field; https:\u002F\u002Fwww.srtr.org\u002Ftools\u002Fkidney-transplant-decision-aid\u002F).\n\nExclusion Criteria (pertain to all participants in Groups 1 and 2):\n\n1. Need for multiple organ transplants.\n2. Severe medical co-morbidities including, but not limited to:\n\n   1. Chronic liver disease.\n   2. Advanced cardiovascular disease.\n   3. Severe peripheral vascular disease that limits technical ability to transplant the GGTA1 KO Thymokidney.\n   4. Severe neurologic diseases or conditions that would preclude meaningful recovery or informed consent.\n   5. Oral steroid-dependent airway disorder or chronic pulmonary disease or requires chronic, intermittent, or continuous supplemental oxygen.\n   6. Pulmonary hypertension.\n   7. Uncontrolled diabetes or sequelae of diabetes mellitus including severe non-proliferative diabetic retinopathy.\n   8. Severe neurogenic bladder that requires intermittent catheterization.\n3. ESRD due to hereditary or structural kidney disease.\n4. Active or recently treated malignancy at the time of informed consent.\n5. Non-renal cause of hematological disorders associated with anemia (eg, thalassemia and sickle disease).\n6. Cannot discontinue chronic anticoagulation therapy (low-dose daily aspirin is permissible).\n7. History of major psychiatric disorders with psychiatric hospitalization and\u002For suicidal ideation within 5 years of informed consent.\n8. Being treated for active tuberculosis (TB), have received prophylaxis for positive FDA-approved interferon-gamma release assay, or test positive for TB by FDA-approved interferon-gamma release assay test during Screening.\n9. Nucleic acid test (NAT) positive for hepatitis B virus and\u002For hepatitis C virus, hepatitis B surface antibody (anti-HBs) titer \\\u003C10 mIU\u002FmL unless the participant is determined to be a nonresponder to hepatitis B vaccination (a nonresponder is defined as having an anti-HB titer \\\u003C10 mIU\u002FmL after having completed both the standard vaccine series and a fourth booster dose and\u002For second standard vaccine series), and\u002For positive for human immunodeficiency virus (HIV; HIV-1 and HIV-2 antibody and\u002For NAT).\n10. Not able to independently perform activities of daily life.\n11. Have a history of medical noncompliance that may preclude adherence to the demands and requirements of xenotransplantation (eg, history of substance use disorder \\[SUD\\] within 1 year of informed consent, lack of social support, untreated psychological conditions).","ALL","40 Years","70 Years",{"count":21,"type":22},50,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety and efficacy of the GGTA1 KO Thymokidney in patients with end-stage renal disease (ESRD) who are either not eligible for conventional allogeneic kidney transplantation (Group 1) or are on an Organ Procurement and Transplantation Network (OPTN) kidney transplant waitlist, but are more likely to die or go untransplanted within 5 years than receive a kidney transplant (Group 2).\n\nThe study consists of xenotransplantation followed by a 24-week Post-transplant Follow-up Period (Part A) to evaluate the efficacy and safety objectives followed by a Long-term Follow-up Period (Part B) to evaluate participant survival, GGTA1 KO Thymokidney survival, and screening for zoonotic infections. Part B will continue for the lifetime of the participant or for 52 weeks following nephrectomy, if required.",[29,30,31],"ESRD (End-Stage Renal Disease)","Kidney Transplantation","Xenotransplantation",[33,34,31,35],"End-stage renal disease","ESRD","GGTA1 KO Thymokidney","RECRUITING","2026-05-26",{"date":39,"type":40},"2026-05-27","ACTUAL",{"date":42,"type":22},"2026-06",{"date":44,"type":22},"2076-03",{"name":46,"class":47},"United Therapeutics","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":71},"100583610","phase-1-study-to-evaluate-the-safety-and-efficacy-of-the-10-ge-xenokidney-in-patients-with-esrd-100583610","NCT06878560","Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With ESRD","EXPAND: A Prospective Study to Evaluate the Safety and Efficacy of the 10 GE Xenokidney in Patients With End-stage Renal Disease (ESRD)","EXPAND","Inclusion Criteria for all Participants (Groups 1 and 2):\n\n1. Provide voluntarily informed consent to participate in the study and for lifetime follow up.\n2. Have a diagnosis of ESRD at the time of informed consent.\n3. Hemodialysis dependent for a minimum of 6 months and has a functioning arterial venous fistula\u002Fgraft or permanent catheter at the time of informed consent.\n4. 50 to 70 years of age at the time of informed consent, or 40 to \\\u003C50 years of a age with a calculated panel reactive antibody (cPRA) of ≥99.9%.\n5. Live withing 3 hours travel time of the xenotransplant center.\n6. Female participants must be postmenopausal or permanently sterilized (eg, hysterectomy, bilateral oophorectomy, or bilateral salpingectomy). Male participants must agree to the use of a highly effective method of birth control, if the possibility of conception exists.\n7. Negative xeno-crossmatch at Screening and pre-transplant.\n8. Estimated Post Transplant Survival Calculator score \\>20% (https:\u002F\u002Foptn.transplant.hrsa.gov\u002Fdata\u002Fallocation-calculators\u002Fepts-calculator\u002F).\n9. Body mass index ≤35 kg\u002Fm2.\n10. Have completed or have initiated and plan to complete (meningococcal A, C, W, Y and meningococcal B vaccine series only) Centers for Disease Control and Prevention recommended courses of age and risk factor appropriate vaccinations.\n11. Seropositive (immunoglobulin G) for cytomegalovirus and Epstein-Barr virus.\n\nAdditional Inclusion Criteria for Group 1:\n\n1\\. Ineligible for conventional allogeneic kidney transplantation due to medical reason(s) for any of the following:\n\n1. Ineligible for a living donor transplant.\n2. Ineligible for an OPTN kidney transplant waitlist (reason for ineligibility will be collected).\n3. Delisted from OPTN kidney transplant waitlist (reason for delisting will be collected).\n\nAdditional Inclusion Criteria for Group 2:\n\n1. On an OPTN kidney transplant waitlist (active or inactive status).\n2. No approved living kidney donors.\n3. More likely to die or go untransplanted within 5 years than receive a kidney transplant as measured by the Kidney Transplant Decision Aid at the time of informed consent (select United States for \"Choose your state\" field and National average for \"Choose your transplant program\" field; https:\u002F\u002Fwww.srtr.org\u002Ftools\u002Fkidney-transplant-decision-aid\u002F).\n\nExclusion Criteria (pertain to all participants in Groups 1 and 2):\n\n1. Need for multiple organ transplants.\n2. Severe medical co-morbidities including, but not limited to:\n\n   1. Chronic liver disease.\n   2. Advanced cardiovascular disease.\n   3. Severe peripheral vascular disease that limits technical ability to transplant the 10 GE Xenokidney.\n   4. Severe neurologic diseases or conditions that would preclude meaningful recovery or informed consent.\n   5. Oral steroid-dependent airway disorder or chronic pulmonary disease or requires chronic, intermittent or continuous supplemental oxygen.\n   6. Pulmonary hypertension.\n   7. Uncontrolled diabetes or sequelae of diabetes mellitus including severe non-proliferative diabetic retinopathy.\n   8. Severe neurogenic bladder that requires intermittent catheterization.\n3. ESRD due to hereditary or structural kidney disease.\n4. Active or recently treated malignancy at the time of informed consent.\n5. Non-renal cause of hematological disorders associated with anemia (eg, thalassemia and sickle disease).\n6. Cannot discontinue chronic anticoagulation therapy (low-dose daily aspirin is permissible).\n7. History of major psychiatric disorders with a psychiatric hospitalization and\u002For suicidal ideation within 5 years of informed consent.\n8. Being treated for active tuberculosis (TB), have received prophylaxis for positive FDA-approved interferon-gamma release assay, or test positive for TB by FDA-approved interferon-gamma release assay test during Screening.\n9. Nucleic acid test (NAT) positive for hepatitis B virus and\u002For hepatitis C virus, hepatitis B surface antibody (anti HBs) titer \\\u003C10 mIU\u002FmL unless the participant is determined to be a nonresponder to hepatitis B vaccination (a nonresponder is defined as having an anti-HBs titer \\\u003C10 mIU\u002FmL after having completed both the standard vaccine series and a fourth booster dose and\u002For second standard vaccine series), and\u002For positive for human immunodeficiency virus (HIV; HIV-1 and HIV-2 antibody and\u002For NAT).\n10. Not able to independently perform activities of daily life.\n11. Have a history of medical noncompliance that may preclude adherence to the demands and requirements of xenotransplantation (eg, history of substance use disorder (SUD) within 1 year of informed consent, lack of social support, untreated psychological conditions).",{"count":21,"type":22},[25,26],"The purpose of this study is to evaluate the safety and efficacy of the 10 GE Xenokidney in patients with ESRD who are either not eligible for conventional allogeneic kidney transplantation (Group 1) or are on an Organ Procurement and Transplantation Network (OPTN) kidney transplant waitlist, but are more likely to die or go untransplanted within 5 years than receive a kidney transplant (Group 2).\n\nThe study consists of xenotransplantation followed by a 24-week Post-transplant Follow up Period (Part A) to evaluate the efficacy and safety objectives followed by a Long-term Follow-up Period (Part B) to evaluate participant survival, 10 GE Xenokidney survival, and screening for zoonotic infections. Part B will continue for the lifetime of the participant.",[29,30,31],[62,33,34,31],"10 GE Xenokidney","2026-03-24",{"date":65,"type":40},"2026-03-27",{"date":67,"type":40},"2025-10-29",{"date":69,"type":22},"2075-10",{"name":46,"class":47},2,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":23,"phases":83,"briefSummary":84,"conditions":85,"keywords":102,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":48},"100560306","phase-1-a-study-to-investigate-safety-and-effectiveness-of-porcine-pancreatic-cells-opf-310-in-patients-with-type-1-diabetes-mellitus-100560306","NCT06575426","A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus","A Phase I\u002FIIa, Single Site, Open-Label, Ascending Dose Study to Evaluate the Safety and Efficacy of OPF-310 [Encapsulated Porcine Islet Cells for Xenotransplantation] in Subjects With Type 1 Diabetes Mellitus","Inclusion Criteria:\n\n1. Subject must be aged 35 to 65 years of age inclusive, at the time of signing the informed consent.\n2. Subject has an established diagnosis of type 1 diabetes mellitus (T1DM)(in accordance with the American Diabetes Association's criteria), with a minimum duration since diagnosis of 5 years.\n3. If one of the following criteria (either a or b) applies:\n\n   1. Subject has unstable T1DM, not achieving adequate control after receiving CLS (CGM:Dexcom G6, insulin pump: Omnipod® 5 or t:slim X2) under care of a qualified diabetes team for at least 6 months prior to enrollment.\n   2. Subject has unstable T1DM, not achieving adequate control after receiving CLS (CGM:Dexcom G7, insulin pump: Omnipod® 5, t:slim X2, iLet Bionic Pancreas or The Tandem Mobi System) under care of a qualified diabetes team for at least 6 months prior to enrollment.\n4. If one of the following criteria (either a, b or c) applies:\n\n   1. Subject has had a Level 3 (severe) hypoglycemic episode (defined as having cognitive impairment requiring external assistance for recovery) at least three times within the 1 year prior to enrollment recorded in the medical record or patient log.\n   2. Subject has had a Level 3 (severe) hypoglycemic episode at least once within the 1 year prior to enrollment and demonstrates a Clarke Score ≥4, assessed by trained study personnel. The SHE(s) and Clarke Score must be recorded in the medical record or patient log.\n   3. Subject has had TBR \\>1% at glucose levels below 70mg\u002FdL and demonstrates a Clarke Score≥4, assessed by trained study personnel. TBR data used for screening and Clarke score must be recorded in the medical record or patient log.\n5. Subject has C-peptide \\\u003C0.3 ng\u002FmL following a mixed meal tolerance test or undetectable fasting C-peptide.\n6. Hemoglobin A1C (HbA1c) ≤ 9.0\n7. Contraceptive use must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies\n8. Subject who can agree to cooperate with lifetime follow-up after transplantation.\n9. Subject is capable of providing signed informed consent\n\nExclusion Criteria:\n\n1. Previous history of insulin resistance (defined as an average insulin dose requirement ≥ 0.8 unit\u002Fkg\u002Fday for 1 week prior to enrollment).\n2. Subject has latent autoimmune diabetes in adults (LADA), ketosis-prone (Flatbush) diabetes, or maturity onset diabetes of the young (MODY).\n3. CRP ≥ 10 mg\u002FL.\n4. Clinically unstable thyroid disease (thyroid stimulating hormone (TSH)\\\u003C the lower limit of the normal range of TSH at the site.) Patients with subclinical hyperthyroidism can be rescreened once TSH levels normalize due to treatment or other factors. In addition, patients with transiently abnormal TSH levels may undergo rescreening only once during the screening period.\n5. History of malignancies within the past 5 years, excluding basal and squamous cell carcinoma\n6. Positive serologies or nucleic acid testing for human immunodeficiency virus (HIV), hepatitis C, and hepatitis B.\n7. Active or untreated proliferative diabetic retinopathy. Subjects may be rescreened once they are successfully treated.\n8. Serious comorbid conditions that are likely to affect participation in the study, including:\n\n   1. Within the last 12 months, peripheral vascular disease with previous amputation.\n   2. History of New York Heart Association (NYHA) class II, III or IV congestive heart failure (CHF) and\u002For chronic atrial fibrillation.\n   3. Chronic obstructive pulmonary disease (COPD) or asthma with previous hospitalization for decompensation; a requirement for mechanical ventilation at any stage; or long- term treatment with oral corticosteroids.\n   4. Macroalbuminuria (\\> 300 mg albumin\u002Fgm creatinine).\n   5. Estimated glomerular filtration rate (eGFR) cut-off of \\\u003C 30 ml\u002Fmin for all per Kidney Disease Improving Global Outcomes (KDOQI) and Kidney Disease Outcomes Quality Initiative (KDIGO) consensus.\n9. Use of warfarin or other anticoagulant therapy (except aspirin), or prothrombin time and international normalized ratio (PT-INR) \\> 1.5\n10. Adrenal insufficiency being treated with corticosteroids\n11. Previous pan-peritonitis\n12. Previous cardiovascular or cerebrovascular disease. NOTE: For the purposes of this exclusion criterion, \"previous cardiovascular disease\" is defined as the presence of co-existing cardiac disease, characterized by any of the following conditions:\n\n    1. Recent myocardial infarction (within past one year), or\n    2. Angiographic evidence of non-correctable coronary artery disease, or\n    3. Evidence of ischemia on functional cardiac exam (with a stress echo test recommended for subjects with a history of ischemic disease), or\n    4. Heart failure \\> NYHAII\n13. Patients with hematopoietic stem cell abnormalities (e.g., aplastic anemia, myelodysplastic syndrome)\n14. Patients who received a blood transfusion in the previous 90 days, are anticipated to undergo surgery during the 1-year study period that may require transfusion, or have donated blood within the previous 90 days.\n15. Previous receipt of an organ, skin allograft, or other tissue transplant from an allogeneic human or animal donor.\n16. Treatment with immunosuppressive medication.\n17. Previous abdominal surgery, excluding uncomplicated appendectomy, cholecystectomy, exploratory laparoscopy and hernia repair performed prior to 12 weeks prior to enrollment.\n18. Treatment with any hypoglycemic medication prescribed for glycemic control, other than insulin therapy.\n19. Treatment with acetaminophen or hydroxycarbamide.\n20. Use of any investigational products within 12 weeks of enrollment (before entering run-in) or 5 half-lives of the investigational product, whichever is greater.\n21. Subject has history of allergy to antibiotics (Amphotericin B, Cefazolin, Ciprofloxacin, Gentamicin), which are used during manufacture of OPF-310.\n22. Previous history of insulin allergy (including porcine insulin), pork product allergy or alginate\u002Fseaweed allergy.\n23. Panel reactive antibodies (PRA) \\> 80 %.\n24. Active drug, substance or alcohol addiction.\n25. Body mass index (BMI) \\>27 kg\u002Fm2.\n26. Any other condition that, in the opinion of the Investigator, may interfere with adherence to the study protocol, including dementia, psychiatric disorder, medical condition, or a history of non-adherence to appointments or treatments","35 Years","65 Years",{"count":82,"type":22},13,[25,26],"This study is First In Human study for Encapsulated Porcine Islet Cells for Xenotransplantation (OPF-310). The purpose of this study to assess the safety, tolerability, and efficacy of OPF-310 transplantation and to define the recommended Phase 2 dose (RP2D) in adult subjects with unstable Type 1 Diabetes Mellitus (T1DM) and a level 3 (severe) hypoglycemic episode at least three times within the 1 year prior to enrollment despite treatment with a closed loop system (CLS) for at least 6 months.",[86,87,88,89,90,91,92,93,94,95,31,96,97,98,99,100,101],"Diabetes Mellitus, Type 1","Hypoglycemia","Islet Cell Transplantation","Type 1 Diabetes","Type 1 Diabetes Mellitus","T1D","T1DM","T1DM - Type 1 Diabetes Mellitus","Type 1 Diabetes (T1D)","Severe Hypoglycemia","Hypoglycemic Episode","Islet Transplantation in Diabetes Mellitus Type 1","Glucose Metabolism Disorders (Including Diabetes Mellitus)","Immune System Diseases","Autoimmune Diseases","Metabolic Disease",[103,104,92,87,105,106,31,107,90,89],"Diabetes Mellitus","Diabetes Mellitus, Type1","islet cell transplantation","pig islet cell transplantation","Porcine islet cell transplantation","2026-02-26",{"date":110,"type":40},"2026-03-02",{"date":112,"type":40},"2025-06-10",{"date":114,"type":22},"2027-06-30",{"name":116,"class":47},"Otsuka Pharmaceutical Factory, Inc."]