[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Regenerative Ocular Immunobiologics LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":4,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":17,"phases":4,"briefSummary":18,"conditions":19,"keywords":4,"overallStatus":21,"whyStopped":4,"lastUpdateSubmitDate":22,"lastUpdatePostDateStruct":23,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":26,"locationsCount":4},"100609135","expanded-access-for-d-mapps-ophthalmic-solution-in-the-treatment-of-chronic-ocular-graft-versus-host-disease-ogvhd-100609135",false,"NCT07210619","Expanded Access for d-MAPPS™ Ophthalmic Solution, in the Treatment of Chronic Ocular Graft-Versus-Host Disease (oGVHD)","Inclusion Criteria:\n\n* Age ≥18 years.\n* Willing and able to provide written informed consent.\n* Willing and able to comply with study assessments for the full duration of the study.\n* Patients may be using bilateral scleral lenses and\u002For bilateral punctal plugs at the time of accrual.\n* Minimum Oxford Schema grade of ≥1 in at least one eye.\n* OSDI score of ≥22.\n* UNC DEMS score of ≥3.\n* In good stable overall health\n* Note: If the patient has no exclusion criteria, investigator can combine the Pre-screen and Baseline visit\n\nExclusion Criteria:\n\n* History of Rheumatoid Arthritis, Lupus, Scleroderma. (Exception may be made at the discretion of the Principal Investigator if it is determined that the patient would benefit from d-MAPPS ophthalmic solution).\n* Ocular or periocular malignancy.\n* Significant change, as judged by the principal investigator, in systemic immunosuppressive regimen within 2 weeks of study entry.\n* Any history of topical tacrolimus use (Exception may be made at the discretion of the Principal Investigator if it is determined that the patient would benefit from d-MAPPS ophthalmic solution).\n* Any change in dosage of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month.\n* Any change in frequency of preserved anti-glaucoma medications within 2 weeks of study entry.\n* Current use of topical steroids more than twice a day.\n* Corneal epithelial defect \\>1mm2.\n* Any history of herpetic keratitis. (Exception may be made at the discretion of the Principal Investigator if it is determined that the patient would benefit from d-MAPPS ophthalmic solution).\n* Participation in another simultaneous medical research study.\n* Signs of current infection, including fever and current treatment with antibiotics.\n* All vaccinations including COVID are prohibited during this study.\n* Intra-ocular surgery or ocular laser surgery within 3 months. (Exception may be made at the discretion of the Principal Investigator if it is determined that the patient would benefit from d-MAPPS ophthalmic solution following surgery.)\n* Women who are pregnant, breastfeeding, or plan to become pregnant while participating in the study. If of child-bearing potential, unwillingness to use effective birth control while participating in the study.)\n* Any condition (including language barrier) that precludes patient's ability to comply with study requirements including completion of study.","ALL","18 Years","EXPANDED_ACCESS","Regenerative Ocular Immunobiologics, LLC Fast Track Expanded Access This Expanded Access Policy describes the conditions under which ROI may make its investigational product - Sterile Processed Derived Multiple Allogeneic Proteins Paracrine Signaling (d-MAPPS™ Ophthalmic Solution) - available to patients outside of a clinical trial, in accordance with U.S. FDA regulations, including section 561A of the Federal Food, Drug, and Cosmetic Act (FDCA).",[20],"oGVHD","AVAILABLE","2025-10-08",{"date":24,"type":25},"2025-10-10","ACTUAL",{"name":27,"class":28},"Regenerative Ocular Immunobiologics LLC","INDUSTRY",""]