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

NCT05413005 | Active Not Recruiting Early Phase 1 DMC

• 1 other identifier: CT.004.1.1.OPERA
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Type 1 Diabetes

Keywords

Type 1 diabetes; Extracorporeal photopheresis; ECP

Outcome Measures

Primary Outcomes (6)

• Tolerability to ECP procedures

  Rate of tolerability of the ECP will be assessed by the number of ECP discontinuation due to adverse events (AE), or withdrawal of participants of the Study due to serious adverse events (SAEs)

  Weeks 0 - 24

• Incidence of adverse events (AEs)

  Incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs): Proportion of participants with AEs as assessed by CTCAE v5.0

  Weeks 0 - 24

• Exogenous insulin use

  Rate of modification in exogenous insulin requirements compared with baseline. Marker for efficacy of treatment: reducing insulin dose

  Baseline, months 3, 6, and 12

• HbA1c levels

  Rate of modification in HbA1c levels compared with baseline. Marker for efficacy of treatment: decreasing for a target HbA1c level of 48 mmol/mol \[6.5%\]

  Baseline, months 3, 6, and 12

• C-peptide levels

  Rate of modification in C-Peptide levels compared with baseline. Marker for efficacy of treatment: increasing C-Peptide levels of ≥ 0.7 ng/mL

  Baseline, months 3, 6, and 12

• Clinically important hypoglycemic episodes

  Frequency of clinically important hypoglycemic episodes (described in Protocol). Marker for efficacy of treatment: requiring decrease of insulin dose)

  Baseline - Month 12

Secondary Outcomes (4)

• Immune response profile (cellular)

  Baseline, months 3, 6, and 12

• Serum IgG levels

  Baseline, months 3, 6, and 12

• Serum IgA levels

  Baseline, months 3, 6, and 12

• Serum IgM levels

  Baseline, months 3, 6, and 12

Study Arms (2)

Group A (ECP regular-intensity arm)

EXPERIMENTAL

ECP in a regular-intensity arm plus T1DM standard of care

Combination Product: ECP regular-intensity arm; Biological: T1DM standard of care

Group B (ECP accelerated-intensity arm)

EXPERIMENTAL

ECP in an accelerated-intensity arm plus T1DM standard of care

Combination Product: ECP accelerated-intensity arm; Biological: T1DM standard of care

Interventions

ECP accelerated-intensity arm COMBINATION_PRODUCT

* 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

Also known as: Extracorporeal photochemotherapy, Extracorporeal photoimmunotherapy

Group B (ECP accelerated-intensity arm)

T1DM standard of care BIOLOGICAL

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)"

Also known as: Multiple Dose Injection (MDI) therapy

Group A (ECP regular-intensity arm); Group B (ECP accelerated-intensity arm)

ECP regular-intensity arm COMBINATION_PRODUCT

* 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)

Also known as: Extracorporeal photochemotherapy, Extracorporeal photoimmunotherapy

Group A (ECP regular-intensity arm)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Confirmed and documented diagnosis of T1DM. Patients must have:
• A documented history of T1DM within the first 3 years of onset.
• Should be on a multiple dose injection (MDI) therapy.
• C-Peptide levels of ˂ 0.7 ng/mL.
• HbA1C ≥ 6.5% to ≤ 10%.
• Evidence of pancreatic autoimmunity, if available (positive anti-glutamic acid decarboxylase \[GAD\]; Islet antigen 2 \[anti-IA2\]; and/or zinc transporter 8 \[ZnT8\] antibodies).
• Male or female aged ≥ 18 to ≤ 50 years.
• Weight \> 40 kg.
• Hematocrit ≥ 32%.
• Platelet count ≥ 100 x10\^9/L (with or without transfusion support).
• Willingness to participate in all OPERA Study tests, visits, and ECP procedures, as outlined in the informed consent.
• Willingness to use at least one reliable method of birth control (e.g. abstinence, oral contraceptives, intrauterine devices, barrier method with spermicide, or surgical sterilization) throughout the study for all men and women of childbearing potential.
• The patient agrees to participate in the trial, and signs the OPERA Study informed consent form.

You may not qualify if:

• Pediatric aged \< 18 or ˃ 50 years.
• Clinical diagnosis of type 2 diabetes mellitus (T2DM).
• Inability to tolerate fluid changes associated with ECP (e.g. inadequate renal, hepatic, pulmonary and cardiac function leading to enable patient to tolerate extracorporeal volume shifts associated with ECP).
• Hypersensitivity or allergy to citrate products.
• Hypersensitivity or allergy to psoralen compounds such as Methoxsalen (8-Methoxypsoralen, 8-MOP).
• Aphakia (8-MOP is contraindicated because of the significantly increased risk of retinal damage due to the absence of lenses).
• Presence of comorbidities that may result in photosensitivity (systemic lupus erythematosus, porphyries, albinism, etc.).
• Suspected or diagnosed Diabetic Ketoacidosis (DKA) at the moment of the screening visit.
• Uncontrolled infection requiring treatment at study entry.
• Laboratory evidence of any of the following:
• White Blood Cell (WBC) count \< 3.00 x10\^9/L.
• Serum transaminase levels \> x2 upper normal limit (UNL).
• Hematocrit \< 32%.
• Platelet count \< 100 x10\^9/L (with or without transfusion support).
• Diagnostic of Hepatitis B Virus (HBV) infection.

Sponsors & Collaborators

• Abu Dhabi Stem Cells Center: lead

Study Sites (1)

Abu Dhabi Stem Cells Center

Abu Dhabi, Abu Dhabi Emirate, 4600, United Arab Emirates

Location

Related Publications (1)

• Castillo-Aleman YM, Lumame S, Castelo C, Rose-Roque JM, Cato M, Atieh M, Onyema M, Villegas-Valverde CA, Bencomo-Hernandez AA, Ventura-Carmenate Y. A Practical Method for Inline-To-Offline Conversion in Extracorporeal Photopheresis. J Clin Apher. 2026 Apr;41(2):e70104. doi: 10.1002/jca.70104.

  PMID: 41755368 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Photopheresis; Therapeutics

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

PUVA Therapy; Ultraviolet Therapy; Phototherapy; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Yandy M Castillo-Aleman, MD

  Abu Dhabi Stem Cells Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: The patients will be randomly allocated (1:1) in a parallel assignment involving two groups of participants: Group A (Regular-intensity arm): 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.

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 9, 2022
• Study Start: September 5, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)