Clinical Research Directory
Browse clinical research sites, groups, and studies.
Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus
Sponsor: Abu Dhabi Stem Cells Center
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
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)
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
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