Could a blood filter help control type 1 diabetes?
NCT ID NCT05413005
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a treatment called extracorporeal photopheresis (ECP) for people with type 1 diabetes. ECP filters and treats a patient's blood with light and a drug, then returns it to the body. The goal is to see if this approach can reduce the need for insulin injections and improve blood sugar control. Ten adults with recent-onset type 1 diabetes will receive ECP alongside standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Sep 2022
- Expected to finish
-
Dec 2026
An estimate. End dates often move.
- Lead sponsor
-
A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 50 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Type 1 diabetes are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Abu Dhabi Stem Cells Center
Abu Dhabi, Abu Dhabi Emirate, 4600, United Arab Emirates
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Tiny horses, big lessons: can ponies help kids tame diabetes?
- Can a math model tune insulin pumps better than standard care?
- Can a group program stop eating disorders in type 1 diabetes?
- Can a Two-Punch immune therapy save insulin cells in newly diagnosed diabetes?
- Can a smart insulin pump tailored for pregnancy protect mothers and babies?
- Can an automated pancreas system make type 1 diabetes safer in the real world?