CompletedPhase 1/2

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

United Arab Emirates15 participantsStarted 2022-03-26

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Demonstrate Expanded Disability Status Scale (EDSS) scores between 3 to 6.5 at screening.
. Documented EDSS progression in the 2 years prior to screening of 1 point or greater for patients with an EDSS score less than 6 at baseline, and greater than or equal to 0.5 for patients with an EDSS score greater than or equal to 6.0 at baseline \*.
. Documented initial onset characterized by a relapsing-remitting course as described in the Diagnostic Criteria.
. Age ≥ 18 ≤ 75 years.
. Weight \> 40 kg.
. Hematocrit ≥ 28 % (with or without transfusion support).
. Platelet count \> 100,000 per μL (with or without transfusion support).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Tolerability to ECP procedures (Group A patients)

Timeframe: Weeks 0-24

Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)

Timeframe: Weeks 0-52

Tolerability to TEAEs, AESIs, and SAEs

Timeframe: Weeks 0-52

Clinical improvement (25-foot walk)

Timeframe: Baseline, months 3, 6, 9, and 12

Clinical improvement (9-hole peg test)

Timeframe: Baseline, months 3, 6, 9, and 12

Clinical improvement (36-Item Short Form Survey)

Timeframe: Baseline, months 3, 6, 9, and 12

Clinical improvement (EDSS baseline low score)

Timeframe: Baseline, months 3, 6, 9, and 12

Trial details

NCT IDNCT05168384

SponsorAbu Dhabi Stem Cells Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-09-01

View on ClinicalTrials.gov More Multiple Sclerosis trials

Plain-language summary

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Demonstrate Expanded Disability Status Scale (EDSS) scores between 3 to 6.5 at screening.
. Documented EDSS progression in the 2 years prior to screening of 1 point or greater for patients with an EDSS score less than 6 at baseline, and greater than or equal to 0.5 for patients with an EDSS score greater than or equal to 6.0 at baseline \*.
. Documented initial onset characterized by a relapsing-remitting course as described in the Diagnostic Criteria.
. Age ≥ 18 ≤ 75 years.
. Weight \> 40 kg.
. Hematocrit ≥ 28 % (with or without transfusion support).
. Platelet count \> 100,000 per μL (with or without transfusion support).

What they're measuring

Tolerability to ECP procedures (Group A patients)

Timeframe: Weeks 0-24

Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)

Timeframe: Weeks 0-52

Tolerability to TEAEs, AESIs, and SAEs

Timeframe: Weeks 0-52

Clinical improvement (25-foot walk)

Timeframe: Baseline, months 3, 6, 9, and 12

Clinical improvement (9-hole peg test)

Timeframe: Baseline, months 3, 6, 9, and 12

Clinical improvement (36-Item Short Form Survey)

Timeframe: Baseline, months 3, 6, 9, and 12

Clinical improvement (EDSS baseline low score)

Timeframe: Baseline, months 3, 6, 9, and 12

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria