[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570137":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":23,"locations":32,"responsibleParty":48,"collaborators":22,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":22,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":76,"whyStopped":22,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"fullName":5,"class":6},"Abu Dhabi Stem Cells Center","OTHER_GOV",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental arm","EXPERIMENTAL","Single group assignment in which SPS patients will receive ECP as an add-on therapy on the following schedule:\n\n* Months 1-3: One ECP cycle (two consecutive days) every other week for 3 months (12 procedures).\n* Months 4-6: One ECP cycle every month for 3 months (6 procedures).",[13],"Combination Product: Extracorporeal photopheresis (ECP)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"COMBINATION_PRODUCT","Extracorporeal photopheresis (ECP)","* Months 1-3: One ECP cycle (two-consecutive days) every other week for 3 months (12 procedures).\n* Months 4-6: One ECP cycle every month for 3 months (6 procedures).\n* Total: 18 procedures (within 6 months \\~24 weeks).",[9],[21],"Extracorporeal photochemotherapy",null,[24,29],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},"Yandy M. Castillo Aleman, MD","CONTACT","+971800810","yandy.castillo@adscc.ae",{"name":30,"role":26,"phone":22,"phoneExt":22,"email":31},"Pierre C. Krystkowiak, MD, PhD","pierre.krystkowiak@capital-health.ae",[33],{"facility":5,"status":22,"city":34,"state":22,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Abu Dhabi","4600","United Arab Emirates","AE",{"type":39,"coordinates":40},"Point",[41,42],54.39696,24.45118,{"lat":42,"lon":41},[45,46],{"name":25,"role":26,"phone":27,"phoneExt":22,"email":28},{"name":47,"role":26,"phone":22,"phoneExt":22,"email":22},"Ruqqia Mir, MBBS",{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"SPONSOR_INVESTIGATOR","Yandy Marx Castillo Aleman","Specialist Immunologist","100570137","early-phase-1-extracorporeal-photopheresis-ecp-in-the-treatment-of-stiff-person-syndrome-option-study-100570137",false,"NCT06703333","Extracorporeal Photopheresis (ECP) in the Treatment of Stiff Person Syndrome (OPTION Study)","A Pilot Study Evaluating the Safety of Extracorporeal Photopheresis (ECP) in the Treatment of Stiff Person Syndrome (OPTION Study)","OPTION","Inclusion Criteria:\n\n* Documented history of classical SPS with serum and CSF anti-GAD antibodies.\n* Age ≥ 18 ≤ 75 years.\n* Weight ≥ 50 kg.\n* Hematocrit ≥ 30 % (with or without transfusion support).\n* Platelet count ≥ 100 x 10\\^3\u002FuL (with or without transfusion support).\n* Willingness to use at least one reliable method of birth control (e.g., abstinence, oral contraceptives, intrauterine devices, barrier method with spermicide, or surgical sterilization) throughout the study for all men and women of childbearing potential.\n* Willingness to participate in all study tests, visits, and procedures (including ECP), as outlined in the informed consent.\n* Adequate peripheral venous access to initiate ECP therapy.\n* The patient agrees to participate in the trial and signs the informed consent form.\n\nExclusion Criteria:\n\n* Progressive encephalomyelitis with rigidity and myoclonus (PERM).\n* Paraneoplastic variants of SPS.\n* Concurrent diagnosis of a neurological condition that would interfere with the assessment of SPS.\n* Women who are pregnant and\u002For lactating.\n* Absolute medical contraindication to receive ECP.\n\n  * Hypersensitivity or allergy to psoralen (methoxalen).\n  * Hypersensitivity or allergy to heparin.\n  * Previous history of heparin-induced thrombocytopenia.\n  * Aphakia or photosensitive disease (systemic lupus erythematosus, porphyrias, etc.).\n* Laboratory evidence of any of the following:\n\n  * Mononuclear cell (MNC) count \\\u003C2.0 x 10\\^3 cells\u002FuL.\n  * Serum transaminase levels \\> x 2 UNL.\n  * Estimated Glomerular Filtration Rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m2.\n* Evidence of known infection with human immunodeficiency virus (HIV) or hepatitis B.\n* Uncontrolled infection requiring treatment at study entry.\n* Use of any investigational drug\u002Ftreatment at the time of enrollment or within the previous 60 days, or five elimination half-lives, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.\n* Previous history of skin cancer, leukemia \u002F lymphoma \u002F myeloma, or bone marrow transplant.\n* Any other disease or condition which, in the opinion of the investigator, could interfere with participation according to the study Protocol, or with the ability of the patients to cooperate and comply with study procedures.\n* Inability to provide informed consent.","ALL","18 Years","75 Years",{"count":64,"type":65},3,"ESTIMATED","INTERVENTIONAL",[68],"EARLY_PHASE1","OPTION study is a pilot, open-label, prospective, and multicentric clinical trial involving outpatients with a diagnosis of classical stiff person syndrome (SPS), whereas extracorporeal photopheresis (ECP) is the investigational treatment. The study will be conducted at the Specialized Rehabilitation Hospital\u002FCapital Health and Yas Clinic Khalifa City (YCKC) Hospital (managed by Abu Dhabi Stem Cells Center -ADSCC), clinical sites responsible for patient assessment and inclusion, and follow-up consultations, according to the approved Protocol, while YCKC will be the site in which patients will undergo the investigational intervention (ECP).",[71],"Stiff Person Syndrome",[71,73,74,75],"Extracorporeal Photopheresis","ECP","Immunoregulation","NOT_YET_RECRUITING","2025-10-01",{"date":79,"type":80},"2025-10-06","ACTUAL",{"date":82,"type":65},"2026-01",{"date":84,"type":65},"2027-07",{"name":50,"class":6},1]