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/Capital 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).
Documented history of classical SPS with serum and CSF anti-GAD antibodies.
Age ≥ 18 ≤ 75 years.
Weight ≥ 50 kg.
Hematocrit ≥ 30 % (with or without transfusion support).
Progressive encephalomyelitis with rigidity and myoclonus (PERM).
Paraneoplastic variants of SPS.
Concurrent diagnosis of a neurological condition that would interfere with the assessment of SPS.
Women who are pregnant and/or lactating.
Yandy Marx Castillo Aleman
Lead sponsor
Abu Dhabi Stem Cells Center
Sponsor institution