[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"BIONCaRT GmbH\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":50},{"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":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":28,"conditions":29,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100591539","phase-1-safety-and-efficacy-of-huc-msc-for-the-treatment-of-cartilage-damage-in-the-knee-joint-100591539",false,"NCT06981741","Safety and Efficacy of hUC-MSC for the Treatment of Cartilage Damage in the Knee Joint","Phase I\u002FIIa Study to Test the Safety and Efficacy of MSC From Umbilical Cord Tissue (UC-MSC) for the Treatment of Cartilage Damage in the Knee Joint","BPCC001","Inclusion Criteria:\n\n* Patients of any gender with an age from ≥ 18 years to ≤ 60 years\n* Clinical indication for a surgical cartilage regeneration procedure\n* Symptomatic grade III\u002FIV cartilage defect according to ICRS or osteochondral defect with a maximum depth of 3 mm\n* A cartilage defect requiring treatment with a defect size of 2-6 cm² on the femoral condyles or patella or trochlea\n* Affected and contralateral knee (if known): Kellgren-Lawrence (K\u002FL) osteoarthritis severity \\\u003C grade III\n* KOOS pain sub-score of ≤ 70 (out of max. 100) in the affected knee joint and \\> 80 (out of max. 100) in the contralateral knee joint measured without taking analgesics within the last 24 hours\n* BMI \\\u003C 35 kg\u002Fm²\n* Written informed consent of the participant, also regarding alternative procedures such as cartilage transplantation (MACT) or matrix-augmented bone marrow stimulation (BMS, AMIC)\n\nExclusion Criteria:\n\n* Clinical indication explicitly for a cartilage regeneration procedure other than the intended study treatment\n* Known varus or valgus malalignment of the affected leg of ≥ 5°\n* Antero-posterior or medio-lateral instability\n* Meniscus loss of more than 20% in the affected compartment\n* Patella instability\n* Simultaneous surgery on other joint structures (cruciate ligament replacement, meniscus suture, partial meniscus resection \\> 20%, osteotomy)\n* Simultaneous higher-grade (ICRS grade III\u002FIV) cartilage damage on the corresponding joint surfaces to the treated cartilage damage (\"kissing lesions\")\n* Osteoarthritis Kellgren-Lawrence (K\u002FL) grade III or IV\n* Arthrofibrosis\n* Metabolic arthropathy\n* Collagenosis\n* Autoimmune disease\n* Tumor disease within the last 5 years\n* Neuromuscular disease\n* Peripheral arterial occlusive disease\n* Intra-articular application of hyaluronic acid or glucocorticoids or platelet concentrates within the last 6 months\n* Joint replacement in the contra-lateral knee or hip within the last 12 months\n* Rheumatoid arthritis or other inflammatory diseases such as autoimmune diseases, seronegative spondyloarthritis, gout, pseudogout\n* Previous fracture in the affected knee joint\n* Osteoporosis\n* Contraindications against the planned operation under general anesthesia\n* Relevant secondary diseases that increase the risk of surgery, e.g. cardiac insufficiency, coronary heart disease, coagulation disorders, diabetes mellitus, liver cirrhosis, renal insufficiency, etc.\n* History of known hypersensitivity to porcine collagens, human albumin, glucose or components of fibrin adhesives used in orthopaedics or surgery\n* Simultaneous participation in another interventional clinical trial (incl. within the last 4 weeks prior to inclusion)\n* Addiction or other illnesses that do not allow the person concerned to assess the nature, scope and possible consequences of the clinical trial (lack of capacity to consent)\n* Indications that the patient is unlikely to adhere to the protocol (e.g. lack of compliance)\n* Persons who are placed in an institution by court or official order\n* Persons who are dependent on the sponsor\n* Pregnant or breastfeeding women\n* Women of childbearing age, except women who meet the following criteria:\n\n  1. Post-menopausal (12 months natural amenorrhea)\n  2. Post-operative (6 weeks after bilateral ovariectomy with or without hysterectomy or bilateral salpingectomy)\n  3. Presence of a negative pregnancy test (urine, not older than 14 days on the day of surgery) and willingness to regularly and correctly use a contraceptive method with a Pearl Index \\\u003C 1 % per year:\n\n     3.1 Combined (oestrogen and progestogen-containing) hormonal contraception 3.2 Hormonal contraception containing progestogens (oral, injected, implanted) 3.3 IUD (hormonal IUD, copper IUD)\n  4. Sexual abstinence\n  5. Vasectomy of the partner",true,"ALL","18 Years","60 Years",{"count":22,"type":23},55,"ESTIMATED","INTERVENTIONAL",[26,27],"PHASE1","PHASE2","Testing the safety and efficacy of MSC from umbilical cord tissue (UC-MSC) for the treatment of cartilage damage in the knee joint",[30],"Cartilage Damage",[32,33,34,35,36],"knee","cartilage","mesenchymal stromal cells","mesenchymal stem cells","UC-MSC","RECRUITING","2026-01-12",{"date":40,"type":41},"2026-01-13","ACTUAL",{"date":43,"type":41},"2025-11-10",{"date":45,"type":23},"2028-11",{"name":47,"class":48},"BIONCaRT GmbH","INDUSTRY",7,""]