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ACTIVE NOT RECRUITING
NCT05413005
EARLY_PHASE1

Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus

Sponsor: Abu Dhabi Stem Cells Center

View on ClinicalTrials.gov

Summary

OPERA Study is a randomized, open-label, prospective, pilot, and a monocentric clinical trial involving outpatients within Abu Dhabi Stem Cells Center (ADSCC) with a confirmed diagnosis of type 1 diabetes mellitus (T1DM). The patients will be randomly allocated (1:1) in a parallel assignment involving two groups of participants: Group A (Regular-intensity arm): Extracorporeal Photopheresis (ECP) on a regular-intensity regimen described in the Protocol as add-on T1DM standard of care, or Group B (Accelerated-intensity arm): ECP on an accelerated regimen plus T1DM standard of care.

Official title: A Randomized, Open-label, Pilot Study Evaluating the Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2022-09-05

Completion Date

2026-12-01

Last Updated

2025-12-26

Healthy Volunteers

No

Conditions

Interventions

COMBINATION_PRODUCT

ECP regular-intensity arm

* Weeks 1-8: Once every 2 weeks: weeks 1, 3, 5, 7 (cryo-ECP bags infused twice-a-week) * Weeks 9-16: Once per month: weeks 9, 13 (cryo-ECP bags infused once-a-week) * Weeks 17-24: One: week 17 (cryo-ECP bags infused every two weeks)

COMBINATION_PRODUCT

ECP accelerated-intensity arm

* Weeks 1-8: Once every week: weeks 1- 7 (cryo-ECP bags infused twice-a-week) * Weeks 9-16: Cryo-ECP bags infused once-a-week * Weeks 17-24: Cryo-ECP bags infused every two weeks

BIOLOGICAL

T1DM standard of care

The standard of care is defined as per the "DOH Standards for diagnosis, management and data reporting for diabetes" in combination with the DOH recommended NICE guidelines "Type 1 diabetes in adults: diagnosis and management (NG17)"

Locations (1)

Abu Dhabi Stem Cells Center

Abu Dhabi, Abu Dhabi Emirate, United Arab Emirates