Study to Assess the Safety and Efficacy of an IT Administration of SCM-010 in SPMS (NCT03696485) | Clinical Trial Compass
WithdrawnPhase 1/2
Study to Assess the Safety and Efficacy of an IT Administration of SCM-010 in SPMS
Stopped: Due to sponsor decision
Israel0Started 2024-02-01
Plain-language summary
Prospective, single center, open label, phase I/IIa escalating dose study. To evaluate the safety and efficacy of escalating doses of SCM-010 in subjects with SPMS.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Male or female subjects (18-60 years of age) diagnosed with SPMS.
✓. SPMS defined as relapsing-remitting disease followed by progression of disability independent of or not explained by multiple sclerosis (MS) relapses for at least 2 years.
✓. Subjects should be ambulatory with an EDSS score of 3-6.5 (inclusive) at screening and baseline visits.
✓. Subjects should be able to go through a lipoaspiration procedure, evaluated by the study's plastic surgeon.
✓. Women capable of child bearing must have a negative urine pregnancy test at screening and baseline visits.
✓. Subjects must use an adequate contraceptive method throughout the study.
✓. Coagulation tests including INR, PTT and prothrombin time (PT) within normal range.
✓. Subjects must be willing and able to comply with the protocol requirements for the duration of the study.
Exclusion criteria
✕. Relapsing remitting multiple sclerosis (RRMS) or primary progressive multiple sclerosis (PPMS) as defined by the revised McDonald criteria.
✕. Any chronic central nervous system (CNS) disease other than SPMS.
✕. Clinical relapse within 3 months prior to study entry.
✕. Subjects diagnosed with any systemic autoimmune disease.