Using Extracorporeal Photopheresis to treat Type 1 Diabetes
A Randomized, Open-label, Pilot Study Evaluating the Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus
This study is testing if a special light treatment can help people with Type 1 Diabetes manage their condition better alongside their usual care.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Abu Dhabi Stem Cells Center Government |
| Locations | 1 site (Abu Dhabi) |
| Trial ID | NCT05413005 on ClinicalTrials.gov |
What this trial studies
The OPERA Study is a randomized, open-label pilot trial conducted at the Abu Dhabi Stem Cells Center, focusing on patients with a confirmed diagnosis of Type 1 Diabetes Mellitus (T1DM). Participants will be randomly assigned to receive either regular or accelerated intensity Extracorporeal Photopheresis (ECP) in addition to standard diabetes care. The study aims to assess the safety and preliminary efficacy of ECP by monitoring insulin use, HbA1c levels, C-peptide levels, and hypoglycemic episodes. The trial will adhere to Good Clinical Practice (GCP) principles and will include comprehensive patient assessments and follow-ups.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 50 with a documented diagnosis of Type 1 Diabetes within the first three years of onset.
Not a fit: Patients with Type 1 Diabetes for more than three years or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve glycemic control and reduce insulin dependency for patients with Type 1 Diabetes.
How similar studies have performed: While the use of ECP in diabetes treatment is novel, similar approaches in other autoimmune conditions have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
* Inclusion Criteria * 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. * Exclusion Criteria * 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. * Diagnostic of Human Immunodeficiency Virus (HIV) infection or Acquired Immunodeficiency Syndrome (AIDS). * Pregnant or lactating women. * Have participated in other clinical trial in the past 3 months. * Organ transplants in the past 3 months. * Current diagnosis of cancer. * Inability to comply with all OPERA Study tests, visits, and procedures (including ECP). * Inability to provide informed consent.
Where this trial is running
Abu Dhabi
- Abu Dhabi Stem Cells Center — Abu Dhabi, United Arab Emirates (Recruiting)
Study contacts
- Principal investigator: Yandy M Castillo-Aleman, MD — Abu Dhabi Stem Cells Center
- Study coordinator: Yandy M Castillo-Aleman, MD
- Email: yandy.castillo@adscc.ae
- Phone: +971800810
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.