A Randomized Controlled Trial of Autologous Immune Cell Therapy in Patients with Newly Diagnosed Highly Active Multiple Sclerosis

The trial enrolled individuals diagnosed with newly diagnosed highly‑active Multiple Sclerosis. Both female and male patients were eligible, representing the patient group defined in the protocol. Age categories corresponded to codes 3 and 4, indicating adult age ranges. The sponsor did not provide the total number of participants, as the rowSubjectCount is zero. Selection was based on diagnosis of highly‑active disease; no additional lifestyle restrictions such as specific diet or physical‑activity requirements were reported. Key inclusion criteria centered on disease activity and recent diagnosis, while exclusion criteria were not detailed in the available information.

The study is a Phase 3 randomized, double-blind, controlled trial evaluating an immune cell therapy in individuals with newly diagnosed highly‑active Multiple Sclerosis. Recruitment is planned to commence on 1 July 2026 and to conclude on 30 September 2029. Eligible participants will first attend a screening visit to confirm inclusion criteria, followed by a baseline visit at which randomization to active therapy or control occurs. Subsequent visits are scheduled to monitor safety, tolerability, and efficacy parameters, culminating in a final end‑of‑study visit that completes the participant’s involvement. The overall period of participation for each enrollee extends from the screening assessment through the end‑of‑study visit, as defined by the study protocol.