[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514998":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":45,"locations":54,"responsibleParty":76,"collaborators":30,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":30,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":30,"overallStatus":56,"whyStopped":30,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Rush University Medical Center","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Autologous (from subject to self) bone marrow aspirate concentrate (BMAC) injections","EXPERIMENTAL","Autologous bone marrow aspirate concentrate (BMAC) will be removed from the subject knee body with a needle, processed and concentrated by an FDA-approved centrifuge (separator) system. The concentrated cells will be injected into the subject knee. \"Autologous\" means that the subject is receiving back their own cells that were collected.",[13],"Other: Autologous bone marrow aspirate concentrate (BMAC)",{"label":15,"type":16,"description":17,"interventionNames":18},"Corticosteroid injection","ACTIVE_COMPARATOR","Corticosteroid injection group (ARM 2) will receive a sham incision.",[19],"Drug: Corticosteroid injections",{"label":21,"type":6,"description":22,"interventionNames":23},"Crossover Group","Any patient in the corticosteroid injection group that shows no improvement in pain after 24 weeks (12 month follow-up if crossover), per physician discretion, will be allowed crossover to the BMAC injection group (ARM 3).",[24],"Other: Crossover Autologous bone marrow aspirate concentrate (BMAC)",[26,31,36],{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Autologous bone marrow aspirate concentrate (BMAC)","Bone marrow aspirate concentrate BMAC is a biologically substance harvested from a patient for autologous use. Bone marrow aspirate concentrate (BMAC) has been determined by the FDA to be a minimally manipulated biologic prepared for autologous use and does not require premarket FDA approval for clinical use.",[9],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":30},"DRUG","Corticosteroid injections","Current standard of treatment for OA of the knee is corticosteroid injection.",[15],{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":30},"Crossover Autologous bone marrow aspirate concentrate (BMAC)","Subjects who participate in this study and who are randomized to receive the BMAC may experience decreased pain and increased functionality after the injection compared to those that receive a corticosteroid injection. As such, participants who continue to have pain after a corticosteroid injection will be allowed to crossover to a BMAC injection at 24 weeks or 6 months post-surgery.(ARM 3)",[21],[41],{"name":42,"affiliation":43,"role":44},"Jorge Chahla, MD","Rush University Medical Center Associate Professor and Surgeon","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":30,"email":50},"Carla M. Edwards, PhD","CONTACT","312-563-5735","carla_edwards@rush.edu",{"name":42,"role":48,"phone":52,"phoneExt":30,"email":53},"(312) 432-2818","jorge.chahla@rushortho.com",[55],{"facility":5,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"RECRUITING","Chicago","Illinois","60612","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-87.65005,41.85003,{"lat":66,"lon":65},[69,71,73],{"name":70,"role":48,"phone":49,"phoneExt":30,"email":50},"Carla M Edwards, PhD",{"name":72,"role":44,"phone":30,"phoneExt":30,"email":30},"Jorge Chahla, MD, PhD",{"name":74,"role":75,"phone":30,"phoneExt":30,"email":30},"Adam Yanke, MD","SUB_INVESTIGATOR",{"type":77,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100514998","bone-marrow-aspirate-concentrate-bmac-vs-corticosteroid-injection-100514998",false,"NCT05985785","Bone Marrow Aspirate Concentrate (BMAC) vs Corticosteroid Injection","Bone Marrow Aspirate Concentrate vs Corticosteroid Injection for Symptomatic Osteoarthritis (OA) of the Knee: A Randomized Controlled Trial","BMAC","Inclusion Criteria:\n\n* Patients between the ages of 18-70\n* Long standing knee pain from osteoarthritis (KL grade 2-3) despite conventional treatments such as activity modification, weight loss, physical therapy, analgesics, nonsteroidal anti-inflammatory drugs, or injection therapy for at least 6 weeks\n* 7-day average pain score of at least 4 on VAS scale\n\nExclusion Criteria:\n\n* Systemic diseases (Diabetes, malignancies, infections, etc.)\n* Post-traumatic arthritis\n* Patient had intra-articular injection on affected knee in last three months","ALL","18 Years","70 Years",{"count":90,"type":91},100,"ESTIMATED","INTERVENTIONAL",[94],"NA","Prospective single-masked (study participant will be masked), randomized controlled trial to examine the influence of BMAC on patient-reported outcomes (PROs) in patients with primary knee osteoarthritis.",[97],"Osteoarthritis of the Knee","2025-08-12",{"date":100,"type":101},"2025-08-13","ACTUAL",{"date":103,"type":101},"2022-07-19",{"date":105,"type":91},"2028-03-31",{"name":5,"class":6},1]