[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"peritoneal-dysfunction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:peritoneal-dysfunction":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100653907","phase-1-the-therapeutic-potential-of-mesenchymal-stem-cell-derived-exosomes-in-peritoneal-dysfunction-100653907",false,"NCT07791667","The Therapeutic Potential of Mesenchymal Stem Cell-derived Exosomes in Peritoneal Dysfunction","A Phase I, Single-center, Open-label Study to Evaluate the Safety, Tolerability, and Dose-finding of Mesenchymal Stem Cell-derived Exosomes in the Treatment of Peritoneal Dialysis-related Peritoneal Dysfunction","Inclusion Criteria:\n\n1. Patients who have been on continuous peritoneal dialysis for more than 1 year.\n2. Age ≥ 18 years.\n3. Patients meeting at least one of the following criteria for peritoneal ultrafiltration insufficiency:\n\n   * Standard PET-confirmed ultrafiltration failure: 4-hour ultrafiltration volume \\\u003C 400 mL using 4.25% glucose dialysate, or \\\u003C 100 mL using 2.5% glucose dialysate; ② 1-hour sodium dip \\\u003C 5 mmol\u002FL and\u002For 1-hour sodium sieve ratio ≤ 0.03 using 4.25% glucose dialysate; ③ Inability to maintain fluid balance, as evidenced by persistent edema\u002Fheart failure symptoms, NT-proBNP \\>11215.2 ng\u002FL, or bioimpedance spectroscopy-assessed overhydration (OH) \\>2 L (after excluding non-peritoneal causes).\n\nExclusion Criteria:\n\n1. Patients with acute renal failure or chronic renal failure who can be temporarily weaned from dialysis.\n2. Patients with malignant tumors, active infections, or severe malnutrition.\n3. Patients with severe hepatic failure or cirrhosis.\n4. Patients with severe cardiovascular disease, severe heart failure (NYHA Class IV or higher), or active systemic diseases.\n5. Patients with peritonitis within the past 3 months or currently experiencing peritonitis.\n6. Patients with encapsulating peritoneal sclerosis (EPS).\n7. Patients with peritoneal dialysis catheter dysfunction.\n8. Planned or ongoing pregnancy.\n9. Simultaneous participation in another interventional clinical trial or drug study.","ALL","18 Years",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this clinical trial is to learn if a single intraperitoneal infusion of mesenchymal stem cell-derived exosomes (MSC-Exos) is safe and tolerable in adults with peritoneal dialysis-related peritoneal failure. It will also explore whether MSC-Exos might improve how well the peritoneum works (ultrafiltration and solute transfer).\n\nThe main questions it aims to answer are:\n\nWhat is the highest single dose of MSC-Exos that can be given safely without causing unacceptable side effects? (This helps find the maximum tolerated dose and the dose to use in future phase II studies.)\n\nWhat medical problems (adverse events) do participants experience after receiving MSC-Exos?\n\nDoes MSC-Exos show any early signs of improving ultrafiltration volume and solute transport across the peritoneum?\n\nResearchers will test increasing doses of MSC-Exos in small groups of participants. Each participant will receive one dose of MSC-Exos added to their usual 1.5% glucose dialysis solution (2 litres), which is then left in the abdominal cavity for 8 hours. The study does not use a placebo; instead, different dose levels are tested one after another to find the safest and most promising dose.\n\nParticipants will:\n\nReceive a single intraperitoneal infusion of MSC-Exos through their dialysis catheter\n\nBe monitored closely before the infusion；\n\nAttend follow-up visits at 24 hours, 72 hours, 2 weeks, and 4 weeks after the dose;\n\nHave blood and peritoneal effluent samples taken at each visit to check for safety ;\n\nHave their ultrafiltration volume and solute transport ability measured at baseline and 4 weeks after the dose to see if any changes occur.\n\nAll participants will be closely observed for any side effects. The results will help decide whether further studies are warranted.",[26],"Peritoneal Dysfunction","NOT_YET_RECRUITING","2026-08-27",{"date":30,"type":31},"2026-08-28","ACTUAL",{"date":33,"type":20},"2026-08",{"date":35,"type":20},"2027-08",{"name":37,"class":38},"Zhujiang Hospital","OTHER"]