[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609135":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":7,"centralContacts":13,"locations":7,"responsibleParty":22,"collaborators":7,"id":24,"slug":25,"hasResults":26,"nctId":27,"briefTitle":28,"officialTitle":7,"acronym":7,"eligibilityCriteria":29,"healthyVolunteers":26,"sex":30,"minAge":31,"maxAge":7,"enrollmentInfo":7,"targetDuration":7,"studyType":32,"phases":7,"briefSummary":33,"conditions":34,"keywords":7,"overallStatus":36,"whyStopped":7,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":7,"completionDateStruct":7,"leadSponsor":41,"locationsCount":7},{"fullName":5,"class":6},"Regenerative Ocular Immunobiologics LLC","INDUSTRY",null,[9],{"type":10,"name":11,"description":12,"armGroupLabels":7,"otherNames":7},"DRUG","d-MAPPS","Ophthalmic Solution for oGVHD",[14,19],{"name":15,"role":16,"phone":17,"phoneExt":7,"email":18},"Marissa Harrell, PhD","CONTACT","727-748-0420","info@roiglobalsolutions.org",{"name":20,"role":16,"phone":21,"phoneExt":7,"email":18},"Craig Hull","7277480420",{"type":23,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","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).",[35],"oGVHD","AVAILABLE","2025-10-08",{"date":39,"type":40},"2025-10-10","ACTUAL",{"name":5,"class":6}]