[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100569298":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":37,"locations":43,"responsibleParty":60,"collaborators":62,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":30,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":30,"enrollmentInfo":77,"targetDuration":30,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":30,"overallStatus":46,"whyStopped":30,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Masonic Cancer Center, University of Minnesota","OTHER",[8,15,18,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm A: MyoPAXon 25 x 10^6","EXPERIMENTAL","MyoPAXon will be delivered via open intramuscular (IM) injection into a single EDB muscle for each participant as a one-time dose. The participants will be started on tacrolimus 1 week prior to dosing and stay on the maintenance dose on a BID schedule for 3 months after injection",[13,14],"Drug: MyoPAXon","Drug: Tacrolimus",{"label":16,"type":10,"description":11,"interventionNames":17},"Arm B: MyoPAXon 50 x 10^6",[13,14],{"label":19,"type":10,"description":11,"interventionNames":20},"Arm C: MyoPAXon 100 x 10^6",[13,14],{"label":22,"type":10,"description":11,"interventionNames":23},"Arm D: MyoPAXon 200 x 10^6",[13,14],[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","MyoPAXon","MyoPAXon is a CD54+ allogeneic muscle progenitor cell product derived from the iPSC line LiPSC-ER2.2",[9,16,19,22],null,{"type":26,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Tacrolimus","Tacrolimus (Prograf) is an immunosuppressant that inhibits calcineurin and T cell activation, and is commonly used to prevent solid organ transplant rejection1 and graft versus host disease (GVHD) as well as allograft rejection in the setting of allogeneic hematopoietic stem cell transplantation.",[9,16,19,22],[36],"Prograf",[38],{"name":39,"role":40,"phone":41,"phoneExt":30,"email":42},"Peter Kang, MD","CONTACT","612-624-9452","mdstemcell@umn.edu",[44],{"facility":45,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Masonic Cancer Center","RECRUITING","Minneapolis","Minnesota","55455","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-93.26384,44.97997,{"lat":56,"lon":55},[59],{"name":39,"role":40,"phone":30,"phoneExt":30,"email":30},{"type":61,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR",[63,66],{"name":64,"class":65},"Duchenne UK","UNKNOWN",{"name":67,"class":6},"Parent Project Muscular Dystrophy","100569298","phase-1-trial-of-cell-based-therapy-for-dmd-100569298",false,"NCT06692426","Trial of Cell Based Therapy for DMD","Phase I Clinical Trial of Cell Based Therapy for Duchenne Muscular Dystrophy","Inclusion Criteria:\n\n* Duchenne muscular dystrophy, diagnosed by mutations in the DMD (dystrophin) gene and\u002For absence of immunohistochemical staining for dystrophin on muscle biopsy\n* Non-ambulatory\n* Intact extensor digitorum brevis (EDB) muscles bilaterally\n* Off investigational therapies for \\> 30 days\n* Age 18 years of age or older at the time of consent\n* Have adequate organ function confirmed by the following laboratory values obtained within 14 days prior to enrollment (28 days for cardiac and pulmonary function):\n* Participants with partners of childbearing potential must be willing to use at least two forms of effective birth control (one form must be a barrier method) while receiving the study product and for 3 months after stopping tacrolimus therapy.\n* Ability to follow commands sufficiently to perform voluntary aspects of outcome measures throughout the study period\n* Willing to consent to monitoring for 15 years, including an extension period, as required for all interventional studies involving the transplantation of cells that have been genetically modified\n* Voluntary written consent from the subject or parent(s)\u002Fguardian(s) and assent from participant prior to the performance of any research related activity.\n\nExclusion Criteria:\n\n* Presence of HLA antibodies directed toward HLA antigens on MyoPAXon\n* Active treatment with another investigational therapy\n* Known allergy to MyoPAXon components","ALL","18 Years",{"count":78,"type":79},8,"ESTIMATED","INTERVENTIONAL",[82],"PHASE1","This is a single-center, single-arm, interventional phase 1 trial to evaluate the safety and tolerability of local injection of induced pluripotent stem cell (iPSC)- derived CD54+ allogeneic muscle progenitor cells in individuals with Duchenne muscular dystrophy (DMD)",[85],"Duchenne Muscular Dystrophy","2026-03-02",{"date":88,"type":89},"2026-03-04","ACTUAL",{"date":91,"type":89},"2025-03-20",{"date":93,"type":79},"2027-03-03",{"name":5,"class":6},1]