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

NCT05168384 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-07

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Abu Dhabi Stem Cells Center

    lead OTHER_GOV

Principal Investigators

  • Yendry Ventura Carmenate, M.D. · Abu Dhabi Stem Cells Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-26
Primary Completion
2025-09-01
Completion
2026-04-27

Countries

  • United Arab Emirates

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05168384 on ClinicalTrials.gov