[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Vericel Corporation\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":78},{"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":19,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":77},"100586427","phase-3-a-study-of-maci-in-patients-aged-17-to-65-years-with-symptomatic-chondral-or-osteochondral-defects-of-the-ankle-100586427","NCT06915233","A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle","A Prospective, Open-label, Randomized, Concurrent Active-controlled, Longitudinal, Multicenter, Phase 3 Clinical Study of the Safety and Efficacy of MACI in Patients With Symptomatic Chondral or Osteochondral Lesions of the Talus (MASCOT)","MASCOT","Inclusion Criteria:\n\n1. Age 17 to 65 at the time of planned randomization visit (Visit 2).\n2. One or more symptomatic chondral or osteochondral lesion\u002Fs as defined by FAOS Pain score ≤ 50 and FAOS Function (SRA) score ≤ 50.\n3. International Cartilage Repair Society (ICRS) Score Grade 3 or 4 chondral or osteochondral lesion\u002Fs located on the talus with or without cysts, including shoulder lesions (lesions on the talar neck), and amenable to treatment with the surgical procedure specified at randomization.\n4. At least 1 lesion ≥ 1.2 cm².\n5. Written informed consent and assent (as applicable) per Institutional Review Board (IRB) requirements.\n6. Participant will refrain from using Non-steroidal Anti-inflammatory Drugs (NSAIDS) for 12 weeks post-study treatment. (Post-surgical use of low-dose aspirin for clot prevention is acceptable).\n7. Participant will restrict pain medication to over-the-counter analgesics (NSAIDs or acetaminophen\u002Fparacetamol) after 12 weeks post-study treatment.\n8. Participant must have Hematocrit ≥30.0%; White Blood Cell count ≤14,000 cells\u002FμL; Platelet Count ≥50,000 platelets\u002FμL; Creatinine ≤2.0 mg\u002FdL; and International Normalized Ratio (INR) ≤1.6.\n\nExclusion Criteria:\n\n1. Lesions with an underlying bony defect depth of \\> 5 mm.\n2. Any surgery on the target joint within 24 weeks prior to Visit 1 (not including diagnostic ankle arthroscopy).\n3. Previous investigational drug, biologic or device use within 12 weeks prior to Visit.\n4. Avascular necrosis of the target ankle.\n5. Symptomatic musculoskeletal conditions in the lower limbs that could impede measurement of efficacy for the target ankle joint.\n6. Participant with \"kissing lesions\" (bipolar lesions, involving both the tibia and talus), or with bilateral lesions in both ankles.\n7. Participant with lesions that require an osteotomy procedure to allow for MACI implantation as determined at the time of ankle arthroscopy (Visit 2).\n8. Concomitant systemic inflammatory diseases or other conditions that affect the joints (e.g., rheumatoid arthritis, metabolic bone disease, psoriasis, symptomatic chondrocalcinosis).\n9. History of advanced or severe osteoarthritis of the ankle as determined by prior surgical history confirming no joint space (i.e., \"bone on bone\") or radiographic evidence of Modified Kellgren-Lawrence Grade 4 arthritis (i.e., osteophytes on lateral and medial malleoli and at the tibiotalar joint margins, narrowing of the joint space width \\> 50%, and tibiotalar sclerosis), Van Dijk Grade III (i.e., total or subtotal destruction of the joint space) or the equivalent.\n10. Known history of septic arthritis in the target ankle joint within 1 year prior to Visit 1.\n11. Current malignancy or treatment for malignancy within the past 5 years prior to Visit 1, excluding non-melanoma skin cancer.\n12. Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin.\n13. Females who are pregnant or lactating.\n14. Patients 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    1. Any condition that has potential for negatively impacting intra- or postoperative course (e.g., uncontrolled diabetes, heavy smoking). - Uncontrolled diabetes is defined as hemoglobin A1c (HbA1c) ≥8.0% and\u002For fasting plasma glucose \\>250 mg\u002FdL (13.9 mmol\u002FL) within the last 90 days prior to Screening Visit 1 - Heavy smoking is defined as current smoker with use of ≥20 cigarettes per day (≥1 pack\u002Fday) at the time of Screening Visit 1.\n    2. Conditions that limit compliance with rehabilitation program.\n    3. Any condition that has potential for significantly limiting participant's ability to assess postoperative ankle function.\n    4. Any condition, psychiatric or otherwise, that would preclude informed consent\u002Fassent, consistent follow-up, or compliance with any aspect of the clinical trial.\n    5. Participant is currently abusing drugs or alcohol or, in the opinion of the Investigator, at high risk for poor compliance.\n    6. Any abnormal screening blood work that the Investigator deems clinically significant in addition to the parameters delineated in Inclusion Criterion #8.\n15. Injection of hyaluronic acid (HA), platelet-rich plasma (PRP), and\u002For corticosteroids in the target ankle within 90 days prior to Visit 1.","65 Years",{"count":59,"type":22},309,[25],"The objective of this study is to demonstrate the superiority of MACI (autologous cultured chondrocytes on porcine collagen membrane) versus Bone Marrow Stimulation in the treatment of patients aged 17 to 65 years with symptomatic articular chondral or osteochondral defects of the talus.",[28,30],[64,65,66,67,68],"Bone Diseases","Musculoskeletal Diseases","Connective Tissue Diseases","Osteochondritis","Cartilage Diseases","2026-05-21",{"date":71,"type":40},"2026-05-27",{"date":73,"type":22},"2026-05",{"date":75,"type":22},"2030-07",{"name":46,"class":47},4,""]