MedTrace Logo

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

NCT05413005 · Status: ACTIVE_NOT_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-26

No results posted yet for this study

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.

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)"

Sponsors & Collaborators

  • Abu Dhabi Stem Cells Center

    lead OTHER_GOV

Principal Investigators

  • Yandy M Castillo-Aleman, MD · Abu Dhabi Stem Cells Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2022-09-05
Primary Completion
2026-09-01
Completion
2026-12-01

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 NCT05413005 on ClinicalTrials.gov