[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"limbal-stem-cell-deficiency\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:limbal-stem-cell-deficiency":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,39,63,92,117,146,171],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100642892","multi-center-prospective-non-interventional-study-in-subjects-with-limbal-stem-cell-deficiency-100642892",false,"NCT07636590","Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency","A Multi-Center, Prospective, Non-Interventional Study in Subjects With Limbal Stem Cell Deficiency","Inclusion Criteria:\n\n* A photopic BCVA in the prospective study eye(s) of ≤ 70 letters at the Screening and Day 1 visits AND a change of ≤ 10 letters in photopic BCVA at Day 1 compared to the Screening Visit\n* Qualifying LSCD diagnosis in the study eye(s) prior to enrollment at Day 1\n* Written confirmation that exclusions on retinal findings are met in the study eye(s) prior to enrollment at Day 1\n* Inflammation associated with LSCD or other non-infectious inflammation (e.g., dry eye, ocular rosacea, and blepharitis) that will not interfere with the subject's participation in the opinion of the investigator is permitted.\n\nExclusion Criteria:\n\n* Any active ocular infection in either eye at either the Screening or Day 1 visits\n* Active sterile iritis or uveitis in either eye at Screening or Day 1 visits\n* Screening visit retinal exam finding, in the opinion of the investigator, that would limit potential for visual acuity gain in the study eye(s)\n\nNote: Other inclusion\u002Fexclusion criteria apply.","ALL","12 Years","99 Years",{"count":20,"type":21},500,"ESTIMATED","OBSERVATIONAL","The goal of this non-interventional, observational study is to describe the natural history, clinical course, and management patterns of subjects with limbal stem cell deficiency (LSCD).",[25],"Limbal Stem Cell Deficiency","RECRUITING","2026-06-03",{"date":29,"type":30},"2026-06-09","ACTUAL",{"date":32,"type":30},"2026-05-22",{"date":34,"type":21},"2028-03",{"name":36,"class":37},"Claris Biotherapeutics, Inc.","INDUSTRY",2,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100550841","phase-1-study-to-evaluate-the-safety-and-efficacy-of-csb-001-ophthalmic-solution-01-in-subjects-with-limbal-stem-cell-deficiency-100550841","NCT06452316","Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency","An Open-Label Study Evaluating the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Subjects With Limbal Stem Cell Deficiency","Inclusion Criteria:\n\n* Have an area of the central 5 mm zone of cornea affected, presence of at least one clinical sign observed by slit-lamp examination with white light and\u002For cobalt blue light, fluorescein, and a Wratten filter, and at least one clinical sign observed with AS-OCT.\n* If dosing with Acthar at time of Screening Visit, must have a history of stable dosing for approximately 8 weeks, plan to maintain the same Acthar treatment dose and regimen, and have demonstrated little to no improvement in severity of LSCD.\n* Sponsor written confirmation of qualifying LSCD diagnosis.\n* Inflammation associated with LSCD or other non-infectious inflammation that will not interfere with subject's participation.\n\nExclusion Criteria:\n\n* Any active ocular infection (bacterial, viral, fungal, or protozoan) in either eye.\n* Ocular surgery within 30 days of Day 0 where investigator assesses that healing is not considered complete\u002Fstable.\n* Planned ocular surgery on or before Week 20 visit.\n* Presence or history of any ocular or systemic disorder, condition, or procedure that might hinder the efficacy of the study treatment or its evaluation, or could interfere with the interpretation of study results, in the opinion of the investigator.\n\nNote: Other inclusion\u002Fexclusion criteria apply.","18 Years",{"count":48,"type":21},75,"INTERVENTIONAL",[51],"PHASE1","This study will enroll subjects with qualifying limbal stem cell deficiency (LSCD). All subjects will receive CSB-001 investigational drug in either one or both study eyes. The study is comprised of two identical phases (Dosing Phase I and II) of test article dosing separated by a 31- to 40-day period, the Dosing Holiday, where no test article is administered. Dosing Phase II is followed by an observational, noninterventional phase (Observation Phase).",[25],"2026-04-27",{"date":56,"type":30},"2026-04-30",{"date":58,"type":30},"2024-05-15",{"date":60,"type":21},"2027-12-31",{"name":36,"class":37},6,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":72,"conditions":73,"keywords":76,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"100602136","association-between-limbal-function-and-tear-proteomics-in-chronic-ocular-diseases-focusing-on-glaucoma-100602136","NCT07119580","Association Between Limbal Function and Tear Proteomics in Chronic Ocular Diseases: Focusing on Glaucoma","Inclusion Criteria:\n\ni. Age ≥ 18 years. ii. Healthy Control Group: No diagnosis of glaucoma or ocular hypertension. iii. Glaucoma, Newly Diagnosed Group: Diagnosed with angle-closure glaucoma, open-angle glaucoma, or ocular hypertension; antiglaucoma medication usage for less than 3 months.\n\niv. Glaucoma, Long-term Medication Group: Diagnosed with angle-closure glaucoma, open-angle glaucoma, or ocular hypertension; continuous use of intraocular pressure-lowering medications for more than 1 year.\n\nv. Glaucoma, Unilateral Group: Diagnosed with unilateral glaucoma or ocular hypertension; only one eye receiving intraocular pressure-lowering treatment.\n\nExclusion Criteria:\n\ni. History of severe ocular trauma, chemical burns, corneal ulcers, Stevens-Johnson syndrome with ocular involvement, or ocular graft-versus-host disease.\n\nii. History of corneal surgery, conjunctival surgery, trabeculectomy, or glaucoma drainage device implantation.\n\niii. Presence of ocular surface irregularity or limbal dysfunction due to conditions other than glaucoma or dry eye disease.",true,{"count":71,"type":21},90,"Background Intact corneal epithelium is important for the defense on the ocular surface, and the function of limbal stem cells is crucial to maintain its integrity. Certain chronic eye diseases, such as glaucoma, require long-term medication use. However, glaucoma patients often exhibit corneal punctate erosions and ocular surface inflammation. In cases where medication has been used for an extended period, patients may even show symptoms similar to limbal stem cell deficiency. Understanding how glaucoma medications affect the function of corneal limbal stem cells is a critical clinical issue.\n\nObjectives To evaluate the effect of glaucoma and anti-glaucoma agents on corneal epithelial and limbal epithelial thickness as a surrogate of limbal stem cell function, and to understand the association between tear fluid proteome and limbal function in glaucoma patients.\n\nMethods We planned to include 90 subjects with glaucoma, and analyze the absolute thickness and variation of corneal epithelium and limbal epithelium. Tear fluid samples will be collected and proteomic analysis will be performed to elucidate the association between protein.\n\nAnticipated Results To elucidate the impact of different types and cumulative doses of glaucoma medications on the thickness of the corneal epithelium and limbal epithelium, and to understand the relationship between limbal function and tear proteomics in glaucoma patients. The expected results may help develop early detection methods for changes in corneal and limbal epithelial function and provide valuable insights for future research on drug design and the protection of limbal stem cells.",[74,75,25],"Glaucoma","Ocular Hypertension",[77,78,74,79,80],"Corneal epithelium","Limbal stem cells","Tear fluid","Proteome","2025-08-06",{"date":83,"type":30},"2025-08-13",{"date":85,"type":30},"2025-07-08",{"date":87,"type":21},"2026-12",{"name":89,"class":90},"National Taiwan University Hospital","OTHER",1,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":100,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":49,"phases":103,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":116},"100190563","autologous-cultured-corneal-epithelium-ceca-for-the-treatment-of-limbal-stem-cell-deficiency-100190563","NCT01756365","Autologous Cultured Corneal Epithelium (CECA) for the Treatment of Limbal Stem Cell Deficiency","Autologous Cultured Corneal Epithelium ( Culture d'épithélium cornéen Autologue CECA) for the Treatment of Unilateral Corneal Lesions Associated With Limbal Stem Cell Deficiency","CECA","Inclusion Criteria:\n\nAll genders\n\n* Adults\n* Minors\n* LSCD in one or two eyes. A minimum of 1-3 mm2 of undamaged limbus is required for a biopsy to be taken without foreseeable adverse consequences for the donor eye\n\nExclusion Criteria:\n\n* Donor eye not sufficiently healthy to allow for the harvesting of a 1-3 mm2 limbal biopsy without foreseeable consequences for the donor eye\n* Pregnancy\n* Breast-feeding\n* Incapacitated person\n* known allergy to aprotinine (Trasylol (R))\n* Hypersensibility to bovine proteins","1 Year",{"count":102,"type":21},54,[104],"NA","The study \" Autologous cultured corneal epithelium (CECA) for the treatment of corneal lesions associated with limbal stem cell deficiency\" is the first clinical trial of this product manufactured at the LOEX laboratory. The culture of corneal epithelium strives to produce a reconstructed tissue with the therapeutical aim of treatment of limbal stem cell deficiency. The study is a phase I\u002Fphase II study with the goal to evaluate safety and efficacy of the CECA graft for the treatment of human patients suffering from limbal stem cell deficiency.\n\nThe trial is open to all genders. The inclusion of 5 minors is planned.",[25],"2025-07-07",{"date":109,"type":30},"2025-07-10",{"date":111,"type":4},"2012-12",{"date":113,"type":21},"2027-12",{"name":115,"class":90},"CHU de Quebec-Universite Laval",4,{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":127,"conditions":128,"keywords":130,"overallStatus":136,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":91},"100353644","cultivated-limbal-epithelial-transplantation-clet-for-limbal-stem-cell-deficiency-lscd-100353644","NCT03884569","Cultivated Limbal Epithelial Transplantation (CLET) for Limbal Stem Cell Deficiency (LSCD)","Cultivated Limbal Epithelial Transplantation (CLET) for Limbal Stem Cell Deficiency (LSCD): an Observational Study on Safety and Effectiveness","CLET-4-LSCD","Total and\u002For severe LSCD of any etiology in one or both eyes.",{"count":126,"type":21},30,"CLET is a published treatment for the management of corneal failure due to extensive LSCD. Due to our previous studies on this novel treatment, the regulatory agency of Spain \"Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)\" authorized our institution (IOBA-University of Valladolid) to perform this kind of therapy (CLET) in a case-by-case base following the Special Situation Medicines Policy Procedure in Spain. Upon approval of the permanent authorization patients will be included as specified by AEMPS.The objective of this study is to perform a protocolized treatment and follow up so that results can be reported to the scientific community.",[129],"Limbal Stem-cell Deficiency",[131,132,133,134,135],"limbal stem cell deficiency","corneal failure","limbal epithelial stem cells","ocular surface","corneal blindness","NOT_YET_RECRUITING","2025-05-14",{"date":139,"type":30},"2025-05-16",{"date":141,"type":21},"2025-11",{"date":143,"type":21},"2025-12-31",{"name":145,"class":90},"Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA",{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":49,"phases":154,"briefSummary":155,"conditions":156,"keywords":157,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":91},"100536474","implementation-of-a-protocol-for-the-transdifferentiation-of-buccal-mucosal-epithelium-into-corneal-epithelium-100536474","NCT06265298","Implementation of a Protocol for the Transdifferentiation of Buccal Mucosal Epithelium Into Corneal Epithelium","TransBuCor","Inclusion Criteria:\n\n* Presenting an indication for conjunctival reconstruction using oral mucosa (for example because of a recurrent pterygium, conjunctival carcinoma or ocular burn)\n* Written consent to participate in this research\n\nExclusion Criteria:\n\n* Chronic infection (HIV, hepatitis, tuberculosis, Lyme disease)\n* Oral pathology which could affect the health of the oral mucosa tissue according to the opinion of the investigating doctor\n* Uncontrolled systemic disease\n* Pregnant or breastfeeding",{"count":116,"type":21},[104],"Objectives The transparent surface of the eye, called the cornea, plays a crucial role in transmitting light to the retina and in protecting the eye. On its external surface, the cornea is composed of a constantly renewing multistratified epithelium. This mechanism is fueled by stem cells located in the limbus (the transition zone between the cornea and the sclera). Limbal Stem Cell Deficiency (LSCD) is characterized by a decrease or cessation of epithelial renewal and neovascularization of the cornea. Consequently, the cornea loses its integrity and transparency. This visually impairing condition is currently in a therapeutic impasse as only autologous limbal or allogeneic corneal grafts are viable options, but they pose significant risks to patients.\n\nStudies have shown that the oral cavity contains stem cells that can be isolated, cultured, and transdifferentiated into limbal stem cells (LSCs). However, to date, these studies are limited, and no protocol has been validated. In this study, the advantage of the accessibility of the oral cavity is used to develop a protocol for differentiating cells from the oral mucosa into limbal stem cells (LSCs) for use in a future clinical trial with patients.\n\nMethodology This prospective monocentric study will be conducted on patients from the ophthalmology department of the Montpellier University Hospital who have an indication for conjunctival reconstruction. After obtaining consent from the patients, cells from the oral wall will be sent to the tissue bank of the Montpellier University Hospital, where they will be cultured. Finally, the transdifferentiation steps will be analyzed by the \"Eye\" research team at the Institute of Neuroscience in Montpellier, which is collaborating on the project. The investigators have established objective factors to assess the success of the developed protocol based on the literature : (i) \\> 3% of stem cells in primary cultures, (ii) \\\u003C10% aborted colonies, (iii) Expression of LSC markers (Pax6, Krt14, p63).",[25],[158,159,160,161],"epithelium","mucosa","cornea","corneal epithelium","2024-08-16",{"date":164,"type":30},"2024-08-19",{"date":166,"type":30},"2024-06-19",{"date":168,"type":21},"2025-06",{"name":170,"class":90},"University Hospital, Montpellier",{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":16,"minAge":178,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":179,"phases":4,"briefSummary":180,"conditions":181,"keywords":185,"overallStatus":189,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":38},"100220642","clinical-trial-on-the-effect-of-autologous-oral-mucosal-epithelial-sheet-transplantation-100220642","NCT02149732","Clinical Trial on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation","An Investigator-initiated Trial (IIT) on the Effect of Autologous Oral Mucosal Epithelial Sheet Transplantation in Corneal Limbal Deficiency Patients","Inclusion Criteria:\n\n1. patient with eye which has limbal stem cell deficiency and conjunctivalization of cornea\n2. patient who shows no improvement after limbal tissue or amniotic membrane transplantation, or who has difficulty in receiving long-term immunosuppressive treatment\n3. patient who agree this clinical trial\n4. patient with the eyes in which best corrected visual acuity is less than counting finger\n5. patient who is older than sixteen year old\n\nExclusion Criteria:\n\n1. patient who has relevant corneal transparency\n2. patient who is on the pregnancy or has a plan of pregnancy within 1 year\n3. patient who has corneal infection\n4. patient who has diagnosis of HBV, HCV, HIV, syphilis\n5. patinet who has past medial history of antinal, myocardial infarction, heart failure, arrhythmia, brain stroke, cerebrovascular disease\n6. patient who has malignancy\n7. patient who shows hypersensitivity to bovine protein.","16 Years","EXPANDED_ACCESS","To investigate the effect of ocular surface reconstruction and assess the safety in cultivated oral mucosal epithelial cell sheet transplantation (COMET) regarding patients with cicatricial change of ocular surface.",[25,182,183,184],"Stevens-johnson Syndrome","Ocular Cicatricial Pemphigoid","Chemical Burn",[186,187,188],"Limbal stem cell deficiency","Cultivated oral mucosal cell sheet transplantation","Ocular surface reconstruction","AVAILABLE","2016-04-18",{"date":192,"type":21},"2016-04-20",{"date":194,"type":4},"2014-05",{"date":196,"type":21},"2016-12",{"name":198,"class":90},"Seoul National University Hospital"]