[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"TricelX Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":44},{"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":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":5},"100630445","phase-1-the-safety-and-efficacy-of-xytrix-umbilical-cord-derived-mesenchymal-stem-cells-in-the-treatment-of-knee-osteoarthritis-100630445",false,"NCT07487766","The Safety and Efficacy of XytriX (Umbilical Cord-Derived Mesenchymal Stem Cells) in the Treatment of Knee Osteoarthritis","A Phase 1\u002F2, Single-Blinded Trial to Evaluate the Safety and Efficacy of Intra-Articular (IA) Injection of XytriX in Adult Subjects With Grade I-IV Knee Osteoarthritis (KOA)","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be eligible for enrollment:\n\nAdult patient aged 18 years or older with Grade I-IV knee osteoarthritis as determined by radiographic (X-ray) evaluation.\n\nAmbulatory subject with symptoms of knee osteoarthritis for at least 3 months, who may be receiving conservative therapy (e.g., oral anti-inflammatory medication) and\u002For physical therapy. In subjects with bilateral knee OA, the more symptomatic knee will be designated as the target knee.\n\nSubject with joint pain equal to or greater than 7 (out of a total pain score of 24 points) on the target knee as assessed by the WOMAC pain subscale.\n\nSubject or legal representative is willing and able to provide written informed consent after reading the informed consent form (ICF) and having the opportunity to discuss the study with the investigator or designee.\n\nWomen of childbearing potential must have a negative urine pregnancy test prior to treatment administration. Women of childbearing potential and males who are heterosexually active with a female of childbearing potential must agree to use a double barrier method of contraception for at least 4 weeks following administration, unless the female partner is post-menopausal (defined as 12 months of spontaneous amenorrhea, or 6 months amenorrhea with FSH \\>40 mIU\u002FmL) or has undergone surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation.\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria will be excluded from participation:\n\nSuspected or confirmed pregnancy, or planning to become pregnant within 2 years of treatment.\n\nBody mass index (BMI) over 40 kg\u002Fm². Knee deformity (varus or valgus greater than 10 degrees) on the target knee. Acute inflammation, tense effusion (e.g., infection), or active bleeding on the target knee as judged by the Principal Investigator (PI).\n\nLigament instability (cruciate or collateral ligaments) or ligament laxity of the target knee as judged by the PI.\n\nHistory of surgery, articular injury, ligament reconstruction, or meniscus repair on the target knee within the previous 6 months.\n\nHistory of arthroscopic surgery in the target knee in the past 6 months, or planned arthroscopy or knee replacement during the trial period.\n\nHistory of total knee replacement procedure on the target knee. Intra-articular injection of any treatment (hyaluronic acid, corticosteroids, or platelet-rich plasma \\[PRP\\]) on the target knee in the last 3 months prior to enrollment.\n\nKnown history of osteoarthritis of the hip or ankle. Known history of any systemic autoimmune rheumatic disease, including but not limited to: rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, ankylosing spondylitis, arthritis associated with inflammatory bowel disease (IBD), sarcoidosis, lymphoma, or amyloidosis.\n\nActive malignancy or treatment for cancer within the past year. Active systemic infection. Known HIV infection. Active hepatitis B or active hepatitis C. Immunocompromised state. Significant concomitant illness as judged by the PI. Hemodynamic instability. Chronic multi-system organ failure. Organ transplant history. Known allergy or hypersensitivity to any component of the investigational product, including DMSO, cell therapies, or hyaluronic acid. Subjects with known sulfur hypersensitivity are specifically excluded due to the DMSO in the cryoprotectant.\n\nKnown allergy or hypersensitivity to any concomitant or rescue medications. Significant skin disease at the injection site on the target knee as judged by the PI.\n\nParticipation in another clinical trial or treatment (immunosuppressant therapies, systemic steroids, cytotoxic drugs, chemotherapy, radiation therapy, new investigational drugs or cell therapy) within 3 months prior to enrollment.\n\nInability to provide informed consent or to have a legal representative provide informed consent.\n\nMedical condition that would, in the opinion of the investigator, compromise the patient's safety or ability to comply with study procedures.","ALL","18 Years",{"count":19,"type":20},75,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This study aims to study the safety and efficacy of XytriX, an umbilical cord-derived stem cell product, in the treatment of Grade I-IV knee osteoarthritis.",[27],"Osteoarthritis",[29,30,27,31],"Knee pain","Stem Cell","Arthritis","NOT_YET_RECRUITING","2026-04-06",{"date":35,"type":36},"2026-04-13","ACTUAL",{"date":38,"type":20},"2026-05",{"date":40,"type":20},"2028-12",{"name":42,"class":43},"TricelX Inc.","INDUSTRY",""]