Type 1 DiabetesEarly Phase 1OPERANCT05413005
Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus
A Early Phase 1 study testing ECP regular-intensity arm and ECP accelerated-intensity arm in people with Type 1 Diabetes, run by Abu Dhabi Stem Cells Center at 1 site in United Arab Emirates.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- ECP regular-intensity arm and ECP accelerated-intensity arm
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 5 Sep 2022to 1 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Abu Dhabi Stem Cells Center
Abu Dhabi, Abu Dhabi Emirate, 4600
About this study
Official title: 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.
Read the detailed description
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 (UK National Institute for Health and Care Excellence) guidelines "Type 1 diabetes in adults: diagnosis and management (NG17)". OPERA Study will be fully conducted in ADSCC, including the patient assessment and inclusion, randomization, ECP procedures, and follow-up consultations, according to this Protocol and GCP principles. All patients will receive T1DM standard of care, plus additional ECP protocols on two regimens of investigational interventions. The primary objective is the safety assessment of ECP, to be assessed by the tolerability to the ECP procedures, incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) assessed by the CTCAE v5.0, and the WHO-UMC causality assessment system. The other primary objective is the preliminary efficacy assessment of the ECP as an add-on treatment to the standard of care for T1DM patients, assessed by the exogenous insulin use, HbA1c levels, C-peptide levels, and clinically important hypoglycemic episodes. The secondary objective is the assessment of the immune response profile in T1DM patients receiving standard of care and additional ECP procedures. The trial is approved by the institutional ADSCC Research Ethics Committee (REC) and written informed consent will be obtained from all patients. OPERA Study will be conducted following the principles of the Declaration of Helsinki and ICH-GCP guidelines.
- Conditions
- Type 1 Diabetes
- Being tested
- ECP regular-intensity arm, ECP accelerated-intensity arm, T1DM standard of care
- Keywords
- Type 1 diabetes, Extracorporeal photopheresis, ECP
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECP regular-intensity armCombination product
Also called Extracorporeal photochemotherapy, Extracorporeal photoimmunotherapy
- 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)
ECP accelerated-intensity armCombination product
Also called Extracorporeal photochemotherapy, Extracorporeal photoimmunotherapy
- 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
T1DM standard of careBiological
Also called Multiple Dose Injection (MDI) therapy
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)"
| Study group | Role | What they receive |
|---|---|---|
| Group A (ECP regular-intensity arm) | Experimental | ECP in a regular-intensity arm plus T1DM standard of care Receives: 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 Receives: Combination Product: ECP accelerated-intensity arm; Biological: T1DM standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: Weeks 0 - 24
Exogenous insulin use
Rate of modification in exogenous insulin requirements compared with baseline. Marker for efficacy of treatment: reducing insulin dose
Measured: 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%]
Measured: 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
Measured: 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)
Measured: Baseline - Month 12
Secondary outcomes (4)
Immune response profile (cellular)
CD3, CD4, CD8, CD11c, CD14, CD16, CD19, CD20, CD25, CD27, CD28, CD38, CD45, CD45RA, CD45RO, CD56, CD57, CD66b, CD123, CD127, CD161, CD294, CCR4, CCR6, CCR7, CXCR3, CXCR5, will be assessed for identification of immune cells and subsets analyses
Measured: Baseline, months 3, 6, and 12
Serum IgG levels
Serum IgG concentration will be assessed for characterization of the humoral response profile
Measured: Baseline, months 3, 6, and 12
Serum IgA levels
Serum IgA concentration will be assessed for characterization of the humoral response profile
Measured: Baseline, months 3, 6, and 12
Serum IgM levels
Serum IgM concentration will be assessed for characterization of the humoral response profile
Measured: Baseline, months 3, 6, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start5 Sep 2022
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abu Dhabi Stem Cells Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yandy M Castillo-Aleman, MD, Principal investigator, Abu Dhabi Stem Cells Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05413005
- Sponsor's protocol ID
- CT.004.1.1.OPERA
- Acronym
- OPERA
- Status last verified
- Dec 2025
- First submitted
- 7 Jun 2022
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41755368
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Pilot Study Evaluating the Efficacy of Extracorporeal Photopheresis (ECP) in the Treatment of Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05413005
- Acronym / sponsor ID
- OPERA / CT.004.1.1.OPERA
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Extracorporeal photopheresis, ECP
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Abu Dhabi Stem Cells CenterOther government
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 (UK National Institute for Health and Care Excellence) guidelines "Type 1 diabetes in adults: diagnosis and management (NG17)". OPERA Study will be fully conducted in ADSCC, including the patient assessment and inclusion, randomization, ECP procedures, and follow-up consultations, according to this Protocol and GCP principles. All patients will receive T1DM standard of care, plus additional ECP protocols on two regimens of investigational interventions. The primary objective is the safety assessment of ECP, to be assessed by the tolerability to the ECP procedures, incidence of treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) assessed by the CTCAE v5.0, and the WHO-UMC causality assessment system. The other primary objective is the preliminary efficacy assessment of the ECP as an add-on treatment to the standard of care for T1DM patients, assessed by the exogenous insulin use, HbA1c levels, C-peptide levels, and clinically important hypoglycemic episodes. The secondary objective is the assessment of the immune response profile in T1DM patients receiving standard of care and additional ECP procedures. The trial is approved by the institutional ADSCC Research Ethics Committee (REC) and written informed consent will be obtained from all patients. OPERA Study will be conducted following the principles of the Declaration of Helsinki and ICH-GCP guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group A (ECP regular-intensity arm) | Experimental | Combination Product: ECP regular-intensity arm, Biological: T1DM standard of careECP in a regular-intensity arm plus T1DM standard of care |
| Group B (ECP accelerated-intensity arm) | Experimental | Combination Product: ECP accelerated-intensity arm, Biological: T1DM standard of careECP in an accelerated-intensity arm plus T1DM standard of care |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
Key exclusion criteria (22 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECP regular-intensity armAlso: Extracorporeal photochemotherapy, Extracorporeal photoimmunotherapy* 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) | Combination product | Group A (ECP regular-intensity arm) |
| ECP accelerated-intensity armAlso: Extracorporeal photochemotherapy, Extracorporeal photoimmunotherapy* 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 | Combination product | Group B (ECP accelerated-intensity arm) |
| T1DM standard of careAlso: Multiple Dose Injection (MDI) therapyThe 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)" | Biological | Group A (ECP regular-intensity arm), Group B (ECP accelerated-intensity arm) |
Primary outcome
Tolerability to ECP procedures
Time frame: Weeks 0 - 24
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)
Incidence of adverse events (AEs)
Time frame: Weeks 0 - 24
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
Exogenous insulin use
Time frame: Baseline, months 3, 6, and 12
Rate of modification in exogenous insulin requirements compared with baseline. Marker for efficacy of treatment: reducing insulin dose
HbA1c levels
Time frame: Baseline, months 3, 6, and 12
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%]
C-peptide levels
Time frame: Baseline, months 3, 6, and 12
Rate of modification in C-Peptide levels compared with baseline. Marker for efficacy of treatment: increasing C-Peptide levels of ≥ 0.7 ng/mL
Clinically important hypoglycemic episodes
Time frame: Baseline - Month 12
Frequency of clinically important hypoglycemic episodes (described in Protocol). Marker for efficacy of treatment: requiring decrease of insulin dose)
4 secondary outcomes
Immune response profile (cellular)
Time frame: Baseline, months 3, 6, and 12
Serum IgG levels
Time frame: Baseline, months 3, 6, and 12
Serum IgA levels
Time frame: Baseline, months 3, 6, and 12
Serum IgM levels
Time frame: Baseline, months 3, 6, and 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Derived from this study: PubMed 41755368Castillo-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yandy M Castillo-Aleman, MD principal investigator
Abu Dhabi Stem Cells Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing ECP regular-intensity arm and ECP accelerated-intensity arm in people with Type 1 Diabetes, run by Abu Dhabi Stem Cells Center at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tolerability to ECP procedures (time frame: Weeks 0 - 24). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05413005, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.