[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591539":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":103,"collaborators":105,"id":114,"slug":20,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":119,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":122,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":20,"studyType":128,"phases":129,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":39,"whyStopped":20,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"BIONCaRT GmbH","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Investigational Product Arm","EXPERIMENTAL","Participants in this arm will undergo arthroscopic or minimally invasive knee surgery, during which the investigational product - mesenchymal stromal cells (MSCs) derived from umbilical cord tissue (MesemCart) - will be applied once directly to the cartilage defect. All patients will receive the same treatment and will be monitored for safety and initial efficacy outcomes over a period of 24 months.",[13],"Biological: BP CC 001",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","BP CC 001","10-20 x 10\\^6 UC-MSC in 1 ml suspension, applied to a collagen carrier structure (Chondro-Gide®)",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Jörg Lützner, Prof.Dr.med.","UniversitätsCentrum für Orthopädie, Unfall- & Plastische Chirurgie, Universitätsklinikum Carl Gustav Carus, TU Dresden","PRINCIPAL_INVESTIGATOR",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":20,"email":31},"Kristina Thamm, PhD","CONTACT","+491607697453","kristina.thamm@bioncart.com",{"name":33,"role":29,"phone":34,"phoneExt":20,"email":35},"Heike Opitz, PhD","+4917672515224","heike.opitz@bioncart.com",[37,49,58,67,76,85,94],{"facility":38,"status":39,"city":40,"state":20,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":20},"Klinikum Altenburger Land, Klinik für Orthopädie und Unfallchirurgie","RECRUITING","Altenburg","04600","Germany",{"type":44,"coordinates":45},"Point",[46,47],12.43684,50.98763,{"lat":47,"lon":46},{"facility":50,"status":39,"city":51,"state":20,"zip":52,"country":42,"cosmosGeoPoint":53,"geoPoint":57,"contacts":20},"St. Nikolaus Stifts-Hospital","Andernach","56626",{"type":44,"coordinates":54},[55,56],7.40425,50.43109,{"lat":56,"lon":55},{"facility":59,"status":39,"city":60,"state":20,"zip":61,"country":42,"cosmosGeoPoint":62,"geoPoint":66,"contacts":20},"Sozialstiftung Bamberg Klinikum am Bruderwald, Klinik für Orthopädie und Unfallchirurgie","Bamberg","96049",{"type":44,"coordinates":63},[64,65],10.90067,49.89873,{"lat":65,"lon":64},{"facility":68,"status":39,"city":69,"state":20,"zip":70,"country":42,"cosmosGeoPoint":71,"geoPoint":75,"contacts":20},"Evangelisches Waldkrankenhaus Spandau","Berlin","13589",{"type":44,"coordinates":72},[73,74],13.41053,52.52437,{"lat":74,"lon":73},{"facility":77,"status":39,"city":78,"state":20,"zip":79,"country":42,"cosmosGeoPoint":80,"geoPoint":84,"contacts":20},"GFO Kliniken Niederrhein, St. Vinzenz Hospital Dinslaken","Dinslaken","46535",{"type":44,"coordinates":81},[82,83],6.7434,51.56227,{"lat":83,"lon":82},{"facility":86,"status":39,"city":87,"state":20,"zip":88,"country":42,"cosmosGeoPoint":89,"geoPoint":93,"contacts":20},"UniversitätsCentrum für Orthopädie, Unfall- & Plastische Chirurgie, Universitätsklinikum Carl Gustav Carus an der TU Dresden","Dresden","01307",{"type":44,"coordinates":90},[91,92],13.73832,51.05089,{"lat":92,"lon":91},{"facility":95,"status":39,"city":96,"state":20,"zip":97,"country":42,"cosmosGeoPoint":98,"geoPoint":102,"contacts":20},"Maria-Josef-Hospital Greven, Klinik für Unfallchirurgie und Orthopädie","Greven","48268",{"type":44,"coordinates":99},[100,101],7.59396,52.09364,{"lat":101,"lon":100},{"type":104,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[106,109,112],{"name":107,"class":108},"KKS Netzwerk","NETWORK",{"name":110,"class":111},"Fraunhofer Institute for Cell Therapy and Immunology IZI","UNKNOWN",{"name":113,"class":6},"Polski Bank Komorek Macierzystych JSC (PBKM)","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":126,"type":127},55,"ESTIMATED","INTERVENTIONAL",[130,131],"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",[134],"Cartilage Damage",[136,137,138,139,140],"knee","cartilage","mesenchymal stromal cells","mesenchymal stem cells","UC-MSC","2026-01-12",{"date":143,"type":144},"2026-01-13","ACTUAL",{"date":146,"type":144},"2025-11-10",{"date":148,"type":127},"2028-11",{"name":5,"class":6},7]