NCT05168384

Safety and Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Multiple Sclerosis

Randomized, Controlled, Open-label Study Evaluating the Safety and Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Multiple Sclerosis

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Abu Dhabi Stem Cells Center · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

PHOMS Study is a randomized, controlled, open-label, prospective, and multicentric clinical trial involving outpatients diagnosed with Secondary Progressive Multiple Sclerosis (SPMS) or Relapsing-Remitting Multiple Sclerosis (RRMS). The primary objective is the safety profile assessment of the investigational intervention (Extracorporeal Photopheresis -ECP) and its preliminary efficacy evaluation, while the secondary objective is the assessment of the immune response profile in MS patients.

Detailed description

PHOMS patients will be randomly allocated (2:1) in a parallel assignment involving two groups of participants: Group A (Experimental group, n = 30): ECP plus Multiple Sclerosis (MS) standard of care, or Group B (Control group, n = 15) receiving MS standard of care alone. The PHOMS Study standard of care is defined by Disease-modifying Therapy (DMT) recommended by the American Academy of Neurology (AAN). The Study will be conducted within Abu Dhabi Stem Cells Center (ADSCC) and Yas Clinic Khalifa City (YCKC) Hospital, including patient assessment and inclusion, randomization, ECP procedures (Group A), and follow-up consultations, according to the approved Protocol and Good Clinical Practices (GCPs) principles. The primary objective is the safety profile assessment of the investigational intervention (ECP), to be assessed by procedure tolerability, the incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0), and the World Health Organization - Uppsala Monitoring Center (WHO-UMC) causality assessment system. The ECP preliminary efficacy assessment, as another primary objective, will be assessed by the proportion of subjects with no evidence of disease progression at 1 year; while the secondary objective is the assessment of the immune response profile in MS patients. All subjects will undergo longitudinal Expanded Disability Status Scale (EDSS), 25-foot walk ambulation test, 9-hole peg test, and 36-Item Short Form Survey (SF-36) testing at baseline and every 3 months through 1 year. Blood will be collected for immunological testing at baseline, months 3, 6, 9, and 12; and subjects will also undergo neuroimaging with brain Magnetic Resonance Imaging (MRI) at baseline, and months 6 and 12 following initiation of treatment, while Chest X-Ray, electrocardiogram (ECG), and echocardiogram can be required at the discretion of the Investigator. The trial is approved by the institutional Research Ethics Committees (RECs), and written informed consent will be obtained from all patients. PHOMS Study will be conducted following the principles of the Declaration of Helsinki and the International Conference on Harmonization (ICH) GCP Guidelines. The authors are responsible for designing the trial and for compiling and analyzing the data.

Conditions

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Multiple Sclerosis, Secondary Progressive

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Extracorporeal Photopheresis	ECP procedures will be performed using a Therakos Cellex integrated, closed photopheresis system (Therakos, Inc., a Mallinckrodt Pharmaceuticals Company). ECP will administered according to the following schedule (Group A): Weeks 1-8: Twice per week (16 sessions). Weeks 9-16: Once per week (8 sessions). Weeks 17-24: Once every 2 weeks (4 sessions). Total: 28 sessions (within 24 weeks).
COMBINATION_PRODUCT	MS standard of care	Disease-modifying Therapy -DMT, recommended by the American Academy of Neurology -AAN

Timeline

• Start date: 2022-03-26
• Primary completion: 2025-09-01
• Completion: 2026-05-01
• First posted: 2021-12-23
• Last updated: 2026-04-09

Locations

1 site across 1 country: United Arab Emirates