[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"osteochondritis-dissecans-ocd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:osteochondritis-dissecans-ocd":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100330956","phase-3-a-study-of-maci-in-patients-aged-10-to-17-years-with-symptomatic-chondral-or-osteochondral-defects-of-the-knee-100330956",false,"NCT03588975","A Study of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee","A Prospective, Open-label, Randomized, Concurrent Active-controlled, Longitudinal, Multicenter, Phase 3 Clinical Study of the Safety and Efficacy of MACI in Patients Aged 10 to 17 Years With Symptomatic Chondral or Osteochondral Defects of the Knee","PEAK","Inclusion Criteria:\n\n* Symptomatic cartilage or osteochondral defects\n* One or more International Cartilage Repair Society (ICRS) Grade III or IV chondral or unsalvageable osteochondral defects located on the femoral condyles and\u002For trochlea amenable to treatment with the surgical procedure determined at randomization (MACI or microfracture).\n\n  1. Concurrent ICRS Grade I and II defects are acceptable on the tibia if they remain untreated (or are treated with debridement only) at the time of study treatment.\n  2. Participants with a potentially re-attachable osteochondral fragment, identified by magnetic resonance imaging (MRI) and that has not previously been repaired, may be consented to the study and undergo baseline assessments per protocol and prior to confirmatory arthroscopy (Visit 2). At arthroscopy, an attempt will be made to reattach the osteochondral fragment. If this is successful, the participant will be excluded from the study and deemed an intra-operative screen failure. If the attempted reattachment fails and no other exclusion criteria apply, the participant may continue in the PEAK study: a MACI biopsy will be taken, the participant will be randomized and treated per protocol.\n* At least 1 defect size ≥1.5 cm2 on the patella, femoral condyles and\u002For the trochlea; defects include OCD lesions with a bone lesion depth of ≤6 mm and does not require a bone graft.\n* Salvageable OCD lesions must have failed prior conservative and a reparative treatment, and the participant still experiences pain associated with the osteochondral lesion. Participants with defects as a result of trauma or unknown etiology are eligible regardless of prior treatments.\n* Stable target knee (i.e., anterior and posterior cruciate ligaments should be free of laxity as well as stable and intact). Ligament repair or reconstruction procedures are allowed prior to screening arthroscopy.\n* Intact meniscus or partial meniscus (at least 50% of functional meniscus remaining) in the target knee. Meniscal repair or resection might be performed either staged or concurrent with the cartilage repair procedure provided that the surgeon was able to confirm that at least 50% of functional meniscus would remain after the corrective meniscal treatment.\n* Written informed consent\n\nExclusion Criteria:\n\n* Any surgery on the target knee joint within 6 months prior to Screening (not including diagnostic arthroscopy)\n* Previous investigational drug or device use within 3 months prior to Screening\n* Avascular necrosis of the target knee (other than potential OCD lesion to be treated)\n* Participants with uninvolved open growth plates where the surgery necessitates crossing the growth plate, or where the depth of the lesion crosses the growth plate\n* ICRS Grade III or IV chondral or unsalvageable osteochondral defects located on the tibia or any lesion that is bipolar to the index lesion\n* Malalignment requiring concurrent osteotomy to correct tibial-femoral or patella-femoral alignment (prior guided growth treatment is not exclusionary)\n* Symptomatic musculoskeletal conditions in the lower limbs that could impede measurement of efficacy for the target knee joint\n* Concomitant inflammatory disease or other conditions that affects the joints (eg, rheumatoid arthritis, metabolic bone disease, psoriasis, symptomatic chondrocalcinosis)\n* Known history of septic arthritis in the index knee joint\n* Current malignancy or treatment for malignancy within the past 5 years\n* Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin\n* Females who are pregnant or lactating\n* Participants who, in the opinion of the Investigator, have significant medical or psychosocial problems that warrant exclusion. Examples of significant problems included but are not limited to:\n\n  * Any condition that has potential for negatively impacting intra or postoperative course\n  * Conditions that limit compliance with rehabilitation program\n  * Any condition that has potential for significantly limiting participant's ability to assess postoperative knee function\n  * Any condition, psychiatric or otherwise, that would preclude informed consent\u002Fassent, consistent follow-up, or compliance with any aspect of the study\n  * Participant is currently abusing drugs or alcohol or, in the opinion of the Investigator, at high risk for poor compliance","ALL","10 Years","17 Years",{"count":21,"type":22},45,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The objective of this study is to compare the efficacy and safety of MACI® vs arthroscopic microfracture in the treatment of participants aged 10 to 17 years with symptomatic articular chondral or osteochondral defects of the knee.",[28,29,30,31],"Chondral Defect","Osteochondritis Dissecans (OCD)","Articular Cartilage Defect","Articular Cartilage Disorder of Knee",[33,34,35],"OCD","cartilage","cartilage defect","RECRUITING","2026-06-19",{"date":39,"type":40},"2026-06-24","ACTUAL",{"date":42,"type":40},"2018-10-24",{"date":44,"type":22},"2030-02",{"name":46,"class":47},"Vericel Corporation","INDUSTRY",12,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":23,"phases":61,"briefSummary":63,"conditions":64,"keywords":67,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":4},"100618481","maioregen-prime-study-for-the-treatment-of-deep-osteochondral-lesion-of-the-knee-100618481","NCT07332182","MaioRegen Prime Study for the Treatment of Deep Osteochondral Lesion of the Knee","Multicenter Prospective Randomized Study of MaioRegenTM Prime vs. Debridement (Surgical Standard of Care (SSOC)) for the Treatment of Osteochondral Lesion of the Knee Joint - OSTEOCONFIRM Study","OSTEOCONFIRM","Inclusion Criteria:\n\n1. Informed consent prior to any study-related procedures;\n2. Male or female patients aged between 18 and 60 years (inclusive);\n3. Body Mass Index (BMI) ≤ 35;\n4. Up to 3 treatable osteochondral lesions localized in femoral condyles and\u002For trochlea (the patient might have other lesion in other parts of the joint, but they should not be more severe than ICRS Grade II lesions as determined by baseline MRI);\n5. Knee osteochondral lesion(s) (Grade IVa and IVb according to ICRS Classification) or not re-fixable knee Osteochondritis Dissecans lesions as determined by baseline MRI;\n6. Lesions with an overall treatable area 1-7 cm2 (as determined by baseline MRI). In case of multiple lesions (maximum 3 lesions) in the same knee compartment a minimum distance of 3 mm is required);\n7. IKDC Subjective score at baseline (pre-op evaluation) is less than 70;\n8. Non-responsive to physical therapy for at least 6 weeks;\n9. Patients physically and mentally willing and able to comply with the post-operative rehabilitation protocol and scheduled clinical and radiographic visits.\n\nExclusion Criteria:\n\n1. IKDC subjective score at Baseline is more than or equal to 70;\n2. KOOS Pain Subscale score at baseline is less than 20 or more than 65 (scale: maximum pain = 0, pain free = 100);\n3. Osteochondral tibial plateau and\u002For patella defects;\n4. Patients affected by advanced osteoarthritis in the index knee (Kellgren and Lawrence classification 3 or 4);\n5. Bony defect depth deeper than 5 mm, according to baseline MRI, measured from the original subchondral bone plate level;\n6. Uncontained defects: lack of vital bone wall at least 2 mm thick, completely surrounding the lesion - based on MRI;\n7. Patients with untreated patellofemoral malalignment or who have undergone realignment procedures within 6 months;\n8. Patients with bone fracture or uncorrected malalignment more than 5 degrees varus or valgus according to standing X-ray.\n9. Patients previously treated for total or partial meniscectomy in the specific index knee compartments (more than 50% of the meniscus in the index compartments is missing);\n10. Patient requiring total or partial meniscectomy to be performed concomitantly, involving more than 50% of one or both menisci in the index knee compartment (lack of functional remaining meniscus, at least 5mm rim at the end of the procedure); and patient requiring ligamentoplasty and high tibial osteotomy (HTO) to be performed concomitantly;\n11. Untreated knee ligament instability or treated within 6 months;\n12. Kissing (counterposed) osteochondral lesions;\n13. Significant instability of the index knee according to IKDC Knee Examination Form 2000: Grade C (abnormal) or D (severely abnormal).\n14. Patients affected by any concomitant painful or disabling disease of the spine, hips, or lower limbs, including the contralateral knee, that would interfere with the evaluation of the index knee;\n15. Patients affected by bilateral knee lesions that need treatment;\n16. Intra-articular steroid injections within 3 months;\n17. Any previous cartilage repair procedure (such as: microfracture, Osteochondral autograft transplantation system (OATS), Autologous Matrix Induced Chondrogenesis, (AMIC), Autologous Chondrocyte Implantation (ACI) with or without use of a scaffold (matrix) in the index knee within one year or debridement within 6 months;\n18. Patients affected by osteoporosis (established through x-ray tests, called DEXA scans, bone density, etc. Criteria for osteoporosis: T-score is \\\u003C - 2.5 SD), chondrodysplasia, or osteogenesis imperfecta;\n19. Patients affected by known allergy to equine collagen or calcium-phosphates;\n20. Patients who underwent chemotherapy in the past 12 months;\n21. Patients with a known history of any significant systemic disease (such as but not limited to: HIV, hepatitis, HTLV, syphilis, coagulopathies, insulin dependent diabetes mellitus etc.) or affected by a significant malignancy;\n22. Participation in other clinical trials within 90 days prior to the study or concurrent with the study;\n23. Patient who is pregnant (or intends to become pregnant within one-year post-op) or breastfeeding;\n24. Known drugs or alcohol abuse;\n25. Any evidence of active infection anywhere in the body. Urinary Tract Infection (UTI) patients can be included following antibiotic treatment, and provided that two consecutive cultures are negative (taken within at least 2 weeks of each other);\n26. Any known history of intra-articular or osseous infection of the index knee;\n27. Patients affected by a known history of inflammatory arthropathy or crystal-deposition arthropathy;\n28. Prisoners;\n29. The existence of any surgical or medical condition that, in the judgement of the Investigator, might compromise patient safety or the outcome of the study;\n30. Any medical conditions or implants that would prevent the participant from undergoing an MRI, including but not limited to pacemakers, clips, cochlear implants, or metal shrapnel.","18 Years","60 Years",{"count":60,"type":22},400,[62],"NA","The present study aims to compare the efficacy and the safety of MaioRegen Prime to Debridement (SSOC) in patients with deep osteochondral lesions of the knee joint. The foreseen population involves patients with osteochondral lesions with different etiology, dimension, shape, and location.\n\nThe evaluation will be performed through clinical, subjective and objective assessments.",[65,29,66],"Osteochondral Lesions of the Knee Joint","Early Osteoarthritis",[68,69,33,70,71,72],"osteochondral lesion","MaioRegen Prime","knee","scaffold","biomimetic","NOT_YET_RECRUITING","2026-01-08",{"date":76,"type":40},"2026-01-12",{"date":78,"type":22},"2026-05",{"date":80,"type":22},"2031-04-30",{"name":82,"class":47},"Fin-Ceramica Faenza Spa"]