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Could a blood filter help control type 1 diabetes?

NCT ID NCT05413005

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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.