NCT05413005 (OPERA) is a EARLY_PHASE1 clinical trial of ECP regular-intensity arm in Type 1 Diabetes, sponsored by Abu Dhabi Stem Cells Center.

Who is sponsoring NCT05413005?

NCT05413005 is sponsored by Abu Dhabi Stem Cells Center.

What drugs are being tested in NCT05413005?

Interventions in NCT05413005: ECP regular-intensity arm, ECP accelerated-intensity arm, T1DM standard of care.

What condition does NCT05413005 study?

NCT05413005 studies Type 1 Diabetes.

Is NCT05413005 still recruiting?

NCT05413005 is currently active, enrolled. Last updated 26 December 2025.

Last reviewed 2025-12-26 · How we verify

NCT05413005: OPERA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Active, enrolled EARLY_PHASE1 Last updated 26 December 2025

What this trial tests

EARLY_PHASE1 trial testing ECP regular-intensity arm in Type 1 Diabetes in 10 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

5 September 2022

Primary endpoint
1 September 2026

1 December 2026

Quick facts

Lead sponsor	Abu Dhabi Stem Cells Center
Phase	EARLY_PHASE1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	5 September 2022
Primary completion	1 September 2026
Estimated completion	1 December 2026
Sites	1 location across United Arab Emirates

Drugs / interventions tested

ECP regular-intensity arm
ECP accelerated-intensity arm
T1DM standard of care — full drug profile →

Conditions studied

Type 1 Diabetes — all drugs for Type 1 Diabetes →

Sponsor

Abu Dhabi Stem Cells Center — full company profile →

Who can join

Adults 18 to 50, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Beyond 8-methoxypsoralen as the photosensitizer for extracorporeal photopheresis.
Castillo-Aleman YM. · · 2022 · cited 1× · PMID 36578936 · DOI 10.3389/fonc.2022.996973
A Practical Method for Inline-To-Offline Conversion in Extracorporeal Photopheresis.
Castillo-Aleman YM, Lumame S, Castelo C, Rose-Roque JM, et al · · 2026 · PMID 41755368 · DOI 10.1002/jca.70104
Extracorporeal photopheresis in stiff person syndrome.
Castillo-Aleman YM, Krystkowiak PC. · · 2024 · PMID 39759515 · DOI 10.3389/fimmu.2024.1519032

Verify or expand the search:

Other recruiting trials for Type 1 Diabetes

Currently open trials in the same condition.

NCT07061574 — A Randomized Phase 1/2 Trial of Low Dose Anti-thymocyte Globulin (ATG) With Subsequent Adalimumab or Verapamil in New On · Phase 1, PHASE2 · recruiting
NCT07360080 — Long-Term Outcomes of Teplizumab in Routine Clinical Care · recruiting
NCT07457580 — Real-World Study of Patients With Type 1 Diabetes Treated With Teplizumab as Part of Managed Access Programs (MAPs) · recruiting
NCT07212179 — Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 · NA · recruiting
NCT07287943 — To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes. · NA · recruiting

Other Abu Dhabi Stem Cells Center trials

Trials by the same sponsor.

NCT05379322 — The Use of Synovial Biopsies in Predicting Response to Biologic Therapy in Rheumatoid Arthritis Patients · Phase 3 · withdrawn
NCT04645485 — Safety and Tolerability of Autologous Non-hematopoietic Peripheral Blood Stem Cells Therapy in Healthy Adult Volunteers. · Phase 1 · completed
NCT04473170 — Study Evaluating the Safety and Efficacy of Autologous Non-Hematopoietic Peripheral Blood Stem Cells in COVID-19 · Phase 1, PHASE2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05413005 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Abu Dhabi Stem Cells Center
Last refreshed: 26 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05413005.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing