Type 1 Diabetes MellitusPhase 3NCT00679042
Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol
A Phase 3 study testing Islets of Langerhans transplantation in people with Type 1 Diabetes Mellitus, run by CellTrans Inc. at 1 site in United States.
Trial summary
In an earlier Phase 1/2 clinical trial using the Edmonton Protocol of steroid free immunosuppression, investigators at University of Illinois at Chicago (UIC) demonstrated the safety of islet preparation, iset transplantation, and medical treatment at UIC. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Islets of Langerhans transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2007to 1 Jul 2026
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes mellitus for more than 5 years complicated by the following situations that persist despite intensive insulin management efforts:
- At least one episode of severe hypoglycemia in the past 3 years defined as an event with symptoms compatible with hypoglycemia in which the subject required the assistance of another person, and which was associated with either a blood glucose level <50 mg/dL (2.8 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration
- Reduced awareness of hypoglycemia, defined by the absence of adequate autonomic symptoms at capillary glucose levels of <54 mg/dL (3 mmol/l) as reported by the subject
Who cannot join
- Co-existing cardiac disease: myocardial infarction within the past 6 months, angiographic evidence of non-correctable coronary artery disease, ischemia on functional cardiac exam, heart failure
- Active alcohol or substance abuse, including cigarette smoking (must be abstinent for six months)
- Psychiatric disorder: schizophrenia, bipolar disorder, or major depression that is unstable on medication
- History of non-adherence to prescribed regimens
- Active infection including hepatitis C, hepatitis B, HIV
- TB by history, current infection, or under treatment for suspected TB
Show all 38Show fewer
- History of malignancies except squamous or basal skin cancer
- Family history of MEN2 or MCT
- Stroke within the past 6 months
- BMI >27 kg/m2
- C-peptide response to glucagon stimulation, any C-peptide >0.3 ng/mL
- Inability to provide informed consent
- Age less than 18 or greater than 75 years
- Creatinine clearance <80 mL/min/1.73 m2 by 24-hour urine collection
- Serum creatinine consistently >1.5 mg/dL
- Macroalbuminuria >300 mg/24h
- Baseline Hb <12 gm/dL in women, <13 gm/dL in men
- Baseline liver function tests outside normal range
- Untreated proliferative retinopathy
- Positive pregnancy test, intent for pregnancy, male's intent to procreate, unwilling to use effective contraception, breast feeding
- Previous transplant or PRA reactivity >80%
- Insulin requirement >0.7 IU/kg/day
- HbA1c >12%
- Hyperlipidemia (fasting cholesterol >130 mg/dL or fasting triglycerides >200 mg/dL
- Medical condition requiring chronic use of steroids
- Use of Coumadin or other antiplatelet or anticoagulant therapy, or PT-INR >1.5
- Factor V deficiency
- Smoking tobacco
- Addison's disease
- Allergy to radiographic contrast material
- Symptomatic cholecystolithiasis
- Acute or chronic pancreatitis
- Symptomatic peptic ulcer disease
- Severe unremitting diarrhea, vomiting, or other gastrointestinal disorders that could interfere with medication absorption
- Treatment with antidiabetic medication other than insulin within 4 weeks of enrollment
- Use of any study medication within 4 weeks of enrollment
- Received live attenuated vaccine(s) within 2 months of enrollment
- Any medical condition that, in the opinion of the investigator, might interfere with safe participation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago Medical Center
Chicago, Illinois, 60612
About this study
Official title: Islet Transplantation in Type 1 Diabetic Patients Using the UIC Protocol, Phase 3
In an earlier Phase 1/2 clinical trial using the Edmonton Protocol of steroid free immunosuppression, investigators at University of Illinois at Chicago (UIC) demonstrated the safety of islet preparation, iset transplantation, and medical treatment at UIC. Therefore, the primary purpose of the present Phase 3 clinical trial is to demonstrate the safety and efficacy of allogeneic islet transplantation in improving glycemic control in Type 1 diabetic patients using the UIC protocol that was developed and proven effective during the Phase 1/2 clinical trial.
Read the detailed description
This study is a Phase 3 single center, uncontrolled trial in which 1-3 allogeneic pancreatic islet transplants are performed for each study subject. Follow-up evaluations after transplant continue for 52 weeks after the final islet transplantation. Thereafter, subjects may enroll for a 5-year follow-up study and an additional 5 year to 10 year follow-up study to evaluate the function of the islets and to measure and regulate immunosuppressive drug levels and side effects.
The safety of islet transplantation depends primarily on the incidence of serious and unexpected complications or adverse events and the ability of the cell isolation laboratory to produce uncontaminated islet cell preparations with minimal endotoxin content.
All study subjects are followed for safety for one year. An independent Data Monitoring Committee (DMC), composed of 3 members who have training in medicine and/or organ transplantation, will review eligibility and safety data within 2 weeks after each islet transplantation and every two months thereafter. An independent monitor, who is knowledgeable about Good Clinical Practice (GCP) guidelines and regulations, monitors the study for compliance with 21 CFR and according to ICH GCP Guidelines. Within the Clinical Research Center, representatives of the Scientific Advisory Committee and the Research Subject Advocacy Program monitor safety. These entities report to the UIC Institutional Review Board (IRB), which also reviews safety data annually and on occurrence of serious adverse events. The principal investigator also reports serious adverse events to the US Food and Drug Administration (FDA).
Success: Islet transplantation is considered a success when subjects do not use insulin, and they achieve a fasting glucose level not exceeding 140 mg/dL more than three times in a week, and not exceeding two-hour post-prandial values of 180 mg/dL more than four times in a week.
Partial Success: Subjects who have a reduction in insulin requirements but who do not achieve insulin independence and present with a reduction in HbA1c and number of hypoglycemic episodes are considered to have partial success of islet transplantation. Reduction in insulin-requirements are assessed by comparing the pre-transplant insulin requirement recorded over two consecutive days (expressed as insulin units per kg) with the requirement on the two consecutive days preceding the subsequent islet infusion, and the requirements on two consecutive days at six months and again on two consecutive days at one year after the final transplant.
Failure: Absence of measurable levels of C-peptide after transplantation is considered as failure of islet cell transplantation.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Islets of Langerhans transplantation
- Keywords
- Diabetes Mellitus Type 1, Type 1 Diabetes Mellitus, Islets of Langerhans Transplantation, Allogeneic Islet transplantation
- 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.
Islets of Langerhans transplantationBiological
Also called Islets of Langerhan (Islets), Basiliximab (Simulect®), Tacrolimus (Prograf®), Sirolimus (Rapamune®)
Each subject may receive 1-3 transplantations of allogeneic human islets of Langerhans and the following medications:
Basiliximab 20 mg iv 2 hours before transplant and 20 mg iv 2 weeks post-transplant; Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml; Sirolimus 0.2 mg/kg loading dose, then 0.1 mg/kg p.o. daily adjusted to reach target trough levels of 10-15 ng/ml during the first 3 months post transplant and 7-10 ng/ml thereafter; Etanercept 50 mg iv 1 hour before transplant and 25 mg s.c. on days 3, 7,and 10 post-transplant; Exenatide 5-mcg s.c. bid for 1 week, then 10 mcg bid for 6 months after each transplant
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | All subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans. Receives: Biological: Islets of Langerhans transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Emergent Adverse Events
Safety endpoints: Incidence and severity of events related to islet infusion, immunosuppression, and islet preparations
Measured: From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year
Number of Subjects Reaching the Efficacy Goal
A successful primary endpoint was defined as HbA1c ≤ 6.5% at the one-year follow-up visit and absence of severe hypoglycemic events (SHE) from Day 28 post-first transplant to 1 year after first and last transplant.
The primary analysis was to estimate the true rate of the composite favorable outcome at 1 year following first and last transplant in patients in the ITT population.
Measured: One year after islet transplant
Secondary outcomes (3)
Number of Patients Presenting With Insulin Independence at Day 365 Post First and Last Transplant
Number of patients presenting with insulin independence, including:
Absence of exogenous insulin injection reported at Day 365.
- Fasting capillary glucose level not exceeding 140 mg/dL (7.8 mmol/L) more than 3 times in a week (based on measuring capillary glucose levels a minimum of 7 times in a 7-day period) at Day 365 ± 28 days.
- Fasting plasma glucose level ≤ 126 mg/dL (7.0 mmol/L) at Day 365 ± 28 days (if the fasting plasma glucose level is > 126 mg/dL [7.0 mmol/L], it must have been confirmed in an additional 1 out of 2 measurements).
- Two-hour post-prandial capillary glucose not exceeding 180 mg/dL (10.0 mmol/L) more than 1 out of every 7 times in a week (based on measuring capillary glucose levels a minimum of 7 times in a 7-day period) at Day 365 ± 28 days.
- Evidence of endogenous insulin production defined as fasting or stimulated C-peptide levels ≥ 0.5 ng/mL (0.16 nmol/L) at Day 365 ± 28 days
Measured: 1 year after islet infusion
Hypoglycemic Episodes by HYPO Score
Hypoglycemic episodes will be measured by the Ryan hypoglycemic (HYPO) Score derived from the number and severity of hypoglycemic episodes recorded throughout the follow-up phase from Day 28 to Day 365.
(From Ryan et al., 2004) "A HYPO score was generated based on a combination of scores from the 4 weeks of readings and the patients' self-reported episodes over the previous year using the scoring system found in online appendix 2 (available at http://diabetes.diabetesjournals.org). The record sheets returned by the patients were analyzed for the number of episodes of glucose values recorded as <2.5 mmol/l and between 2.5 and 2.9 mmol/l. Points were awarded if symptoms were absent or were neuroglycopenic rather than autonomic... Thus the more severe the problem with hypoglycemia, the higher the score." A Ryan score ranges from 0 (no event) to a cumulative sum of episode points of total events reported during the 4 weeks then multiplied by 13 to provide a 1-year value.
Measured: One year after the last transplant
Reduction in Hypoglycemic Severity Measured by %Reduction in HYPO Score
%reduction in Ryan HYPO Score [%(baseline score - 1-year post transplant score)/baseline] at time of evaluation.
Measured: One year after the first and last transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2008 (estimated)
- Study start5 Sep 2007
- Primary completion19 Jul 2017
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- CellTrans Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Jose Oberholzer, University of Illinois Chicago
- Investigators
- Jose Oberholzer, MD, Principal investigator, University of Illinois Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00679042
- Sponsor's protocol ID
- IND11807-2007-0330
- Status last verified
- Oct 2026
- First submitted
- 13 May 2008
- Last updated
- 4 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
- Expanded access
- Available
Publications
Ajmal N, Bogart MC, Khan P, Max-Harry IM, Healy AM, Nunemaker CS. Identifying Promising Immunomodulators for Type 1 Diabetes (T1D) and Islet Transplantation. J Diabetes Res. 2024 Dec 20;2024:5151171. doi: 10.1155/jdr/5151171. eCollection 2024.
PubMed 39735417Luu QF, Villareal CJ, Fritschi C, Monson RS, Oberholzer J, Danielson KK. Concerns and hopes of patients with type 1 diabetes prior to islet cell transplantation: A content analysis. J Diabetes Complications. 2018 Jul;32(7):677-681. doi: 10.1016/j.jdiacomp.2018.04.002. Epub 2018 Apr 17.
PubMed 29779835
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Islet Transplantation in Type 1 Diabetic Patients Using the UIC Protocol, Phase 3
- ClinicalTrials.gov ID
- NCT00679042
- Acronym / sponsor ID
- IND11807-2007-0330
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Diabetes Mellitus Type 1, Type 1 Diabetes Mellitus, Islets of Langerhans Transplantation, Allogeneic Islet transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- CellTrans Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2007 (actual)
- Primary completion
- 19 Jul 2017 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 16 May 2008 (estimated)
- Results
- Posted 6 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In an earlier Phase 1/2 clinical trial using the Edmonton Protocol of steroid free immunosuppression, investigators at University of Illinois at Chicago (UIC) demonstrated the safety of islet preparation, iset transplantation, and medical treatment at UIC. Therefore, the primary purpose of the present Phase 3 clinical trial is to demonstrate the safety and efficacy of allogeneic islet transplantation in improving glycemic control in Type 1 diabetic patients using the UIC protocol that was developed and proven effective during the Phase 1/2 clinical trial.
Detailed description
This study is a Phase 3 single center, uncontrolled trial in which 1-3 allogeneic pancreatic islet transplants are performed for each study subject. Follow-up evaluations after transplant continue for 52 weeks after the final islet transplantation. Thereafter, subjects may enroll for a 5-year follow-up study and an additional 5 year to 10 year follow-up study to evaluate the function of the islets and to measure and regulate immunosuppressive drug levels and side effects.
The safety of islet transplantation depends primarily on the incidence of serious and unexpected complications or adverse events and the ability of the cell isolation laboratory to produce uncontaminated islet cell preparations with minimal endotoxin content.
All study subjects are followed for safety for one year. An independent Data Monitoring Committee (DMC), composed of 3 members who have training in medicine and/or organ transplantation, will review eligibility and safety data within 2 weeks after each islet transplantation and every two months thereafter. An independent monitor, who is knowledgeable about Good Clinical Practice (GCP) guidelines and regulations, monitors the study for compliance with 21 CFR and according to ICH GCP Guidelines. Within the Clinical Research Center, representatives of the Scientific Advisory Committee and the Research Subject Advocacy Program monitor safety. These entities report to the UIC Institutional Review Board (IRB), which also reviews safety data annually and on occurrence of serious adverse events. The principal investigator also reports serious adverse events to the US Food and Drug Administration (FDA).
Success: Islet transplantation is considered a success when subjects do not use insulin, and they achieve a fasting glucose level not exceeding 140 mg/dL more than three times in a week, and not exceeding two-hour post-prandial values of 180 mg/dL more than four times in a week.
Partial Success: Subjects who have a reduction in insulin requirements but who do not achieve insulin independence and present with a reduction in HbA1c and number of hypoglycemic episodes are considered to have partial success of islet transplantation. Reduction in insulin-requirements are assessed by comparing the pre-transplant insulin requirement recorded over two consecutive days (expressed as insulin units per kg) with the requirement on the two consecutive days preceding the subsequent islet infusion, and the requirements on two consecutive days at six months and again on two consecutive days at one year after the final transplant.
Failure: Absence of measurable levels of C-peptide after transplantation is considered as failure of islet cell transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: Islets of Langerhans transplantationAll subjects will receive up to 3 transplantations of allogeneic human islets of Langerhans. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 1 diabetes mellitus for more than 5 years complicated by the following situations that persist despite intensive insulin management efforts:
- At least one episode of severe hypoglycemia in the past 3 years defined as an event with symptoms compatible with hypoglycemia in which the subject required the assistance of another person, and which was associated with either a blood glucose level <50 mg/dL (2.8 mmol/L) or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon administration
- Reduced awareness of hypoglycemia, defined by the absence of adequate autonomic symptoms at capillary glucose levels of <54 mg/dL (3 mmol/l) as reported by the subject
Key exclusion criteria (38 listed)
- Co-existing cardiac disease: myocardial infarction within the past 6 months, angiographic evidence of non-correctable coronary artery disease, ischemia on functional cardiac exam, heart failure
- Active alcohol or substance abuse, including cigarette smoking (must be abstinent for six months)
- Psychiatric disorder: schizophrenia, bipolar disorder, or major depression that is unstable on medication
- History of non-adherence to prescribed regimens
- Active infection including hepatitis C, hepatitis B, HIV
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 |
|---|---|---|
| Islets of Langerhans transplantationAlso: Islets of Langerhan (Islets), Basiliximab (Simulect®), Tacrolimus (Prograf®), Sirolimus (Rapamune®)Each subject may receive 1-3 transplantations of allogeneic human islets of Langerhans and the following medications: Basiliximab 20 mg iv 2 hours before transplant and 20 mg iv 2 weeks post-transplant; Tacrolimus 1 mg p.o. bid adjusted to reach target trough levels of 3-6 ng/ml; Sirolimus 0.2 mg/kg loading dose, then 0.1 mg/kg p.o. daily adjusted to reach target trough levels of 10-15 ng/ml during the first 3 months post transplant and 7-10 ng/ml thereafter; Etanercept 50 mg iv 1 hour before transplant and 25 mg s.c. on days 3, 7,and 10 post-transplant; Exenatide 5-mcg s.c. bid for 1 week, then 10 mcg bid for 6 months after each transplant | Biological | Treatment |
Primary outcome
Treatment Emergent Adverse Events
Time frame: From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year
Safety endpoints: Incidence and severity of events related to islet infusion, immunosuppression, and islet preparations
Number of Subjects Reaching the Efficacy Goal
Time frame: One year after islet transplant
A successful primary endpoint was defined as HbA1c ≤ 6.5% at the one-year follow-up visit and absence of severe hypoglycemic events (SHE) from Day 28 post-first transplant to 1 year after first and last transplant. The primary analysis was to estimate the true rate of the composite favorable outcome at 1 year following first and last transplant in patients in the ITT population.
3 secondary outcomes
Number of Patients Presenting With Insulin Independence at Day 365 Post First and Last Transplant
Time frame: 1 year after islet infusion
Hypoglycemic Episodes by HYPO Score
Time frame: One year after the last transplant
Reduction in Hypoglycemic Severity Measured by %Reduction in HYPO Score
Time frame: One year after the first and last transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39735417Ajmal N, Bogart MC, Khan P, Max-Harry IM, Healy AM, Nunemaker CS. Identifying Promising Immunomodulators for Type 1 Diabetes (T1D) and Islet Transplantation. J Diabetes Res. 2024 Dec 20;2024:5151171. doi: 10.1155/jdr/5151171. eCollection 2024.
- Derived from this study: PubMed 29779835Luu QF, Villareal CJ, Fritschi C, Monson RS, Oberholzer J, Danielson KK. Concerns and hopes of patients with type 1 diabetes prior to islet cell transplantation: A content analysis. J Diabetes Complications. 2018 Jul;32(7):677-681. doi: 10.1016/j.jdiacomp.2018.04.002. Epub 2018 Apr 17.
- UI Health Islet Cell TransplantLink provided by the sponsor.
- The Chicago Diabetes Project HomepageLink provided by the sponsor.
- 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.
Jose Oberholzer, MD principal investigator
University of Illinois Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Islets of Langerhans transplantation in people with Type 1 Diabetes Mellitus, run by CellTrans Inc. at 1 site in United States.
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 3 inclusion and 38 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: finished, as of the sponsor's last update on 4 Nov 2026. 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 States. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Emergent Adverse Events (time frame: From first islet transplant through one year after last transplant (maximum 3 infusions possible), an average of 1 year). The study lists 2 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 NCT00679042, which also lists 2 linked publications.
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 4 Nov 2026.