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