[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100591539":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":36,"responsibleParty":104,"collaborators":106,"id":115,"slug":116,"hasResults":117,"nctId":118,"briefTitle":119,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":123,"sex":124,"minAge":125,"maxAge":126,"enrollmentInfo":127,"targetDuration":20,"studyType":130,"phases":131,"briefSummary":134,"conditions":135,"keywords":137,"overallStatus":39,"whyStopped":20,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},{"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",[37,50,59,68,77,86,95],{"facility":38,"status":39,"city":40,"state":20,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":20},"Klinikum Altenburger Land, Klinik für Orthopädie und Unfallchirurgie","RECRUITING","Altenburg","04600","Germany","DE",{"type":45,"coordinates":46},"Point",[47,48],12.43684,50.98763,{"lat":48,"lon":47},{"facility":51,"status":39,"city":52,"state":20,"zip":53,"country":42,"countryCode":43,"cosmosGeoPoint":54,"geoPoint":58,"contacts":20},"St. Nikolaus Stifts-Hospital","Andernach","56626",{"type":45,"coordinates":55},[56,57],7.40425,50.43109,{"lat":57,"lon":56},{"facility":60,"status":39,"city":61,"state":20,"zip":62,"country":42,"countryCode":43,"cosmosGeoPoint":63,"geoPoint":67,"contacts":20},"Sozialstiftung Bamberg Klinikum am Bruderwald, Klinik für Orthopädie und Unfallchirurgie","Bamberg","96049",{"type":45,"coordinates":64},[65,66],10.90067,49.89873,{"lat":66,"lon":65},{"facility":69,"status":39,"city":70,"state":20,"zip":71,"country":42,"countryCode":43,"cosmosGeoPoint":72,"geoPoint":76,"contacts":20},"Evangelisches Waldkrankenhaus Spandau","Berlin","13589",{"type":45,"coordinates":73},[74,75],13.41053,52.52437,{"lat":75,"lon":74},{"facility":78,"status":39,"city":79,"state":20,"zip":80,"country":42,"countryCode":43,"cosmosGeoPoint":81,"geoPoint":85,"contacts":20},"GFO Kliniken Niederrhein, St. Vinzenz Hospital Dinslaken","Dinslaken","46535",{"type":45,"coordinates":82},[83,84],6.7434,51.56227,{"lat":84,"lon":83},{"facility":87,"status":39,"city":88,"state":20,"zip":89,"country":42,"countryCode":43,"cosmosGeoPoint":90,"geoPoint":94,"contacts":20},"UniversitätsCentrum für Orthopädie, Unfall- & Plastische Chirurgie, Universitätsklinikum Carl Gustav Carus an der TU Dresden","Dresden","01307",{"type":45,"coordinates":91},[92,93],13.73832,51.05089,{"lat":93,"lon":92},{"facility":96,"status":39,"city":97,"state":20,"zip":98,"country":42,"countryCode":43,"cosmosGeoPoint":99,"geoPoint":103,"contacts":20},"Maria-Josef-Hospital Greven, Klinik für Unfallchirurgie und Orthopädie","Greven","48268",{"type":45,"coordinates":100},[101,102],7.59396,52.09364,{"lat":102,"lon":101},{"type":105,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[107,110,113],{"name":108,"class":109},"KKS Netzwerk","NETWORK",{"name":111,"class":112},"Fraunhofer Institute for Cell Therapy and Immunology IZI","UNKNOWN",{"name":114,"class":6},"Polski Bank Komorek Macierzystych JSC (PBKM)","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":128,"type":129},55,"ESTIMATED","INTERVENTIONAL",[132,133],"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",[136],"Cartilage Damage",[138,139,140,141,142],"knee","cartilage","mesenchymal stromal cells","mesenchymal stem cells","UC-MSC","2026-01-12",{"date":145,"type":146},"2026-01-13","ACTUAL",{"date":148,"type":146},"2025-11-10",{"date":150,"type":129},"2028-11",{"name":5,"class":6},7]