EVIFIT — extracellular vesicles and donor-islet quality
What this study tests
A Strasbourg observational study targeting 25 adults with T1D on an islet-transplant waiting list. It explores whether extracellular vesicles from islet preparations relate to graft quality and function. No results are posted, and the registration does not assign patients an extracellular-vesicle treatment.
Editorial review: . 16 September review-note archive (earlier notes may not cover later changes).
Registry checked: 2026-09-17. Registry’s own update: 2026-09-10.
Most recent recorded citation date: 2026-09-10. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. Review coverage and open work · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adults 18+ with T1D on the pancreatic-islet transplant waiting list and consent for research reuse of their data. The registry excludes pregnancy and specified legal-protection situations; full criteria and actual recruitment must be confirmed with the study team. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No results posted in the registry as checked 17 September 2026. Enrollment figures are planned targets, not observed outcomes.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: European Union. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the 16 September review-note archive and current review coverage. Later changes and new records may not appear in the earlier notes. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Primary graft function one month after the last islet injection, assessed with the BETA-2 score
- Graft success using the IGLS score one and two years after transplantation
The full picture
Research question
EVIFIT is registered as a prospective observational cohort at Strasbourg, with an estimated 25 adults who have T1D and are on an islet-transplant waiting list. Its hypothesis is that extracellular vesicles released during islet preparation may reflect graft quality and have protective or harmful effects. The proposal to improve islet fitness through vesicle-based preparation is a research hypothesis, not a demonstrated human treatment benefit.1
What is measured
The listed primary outcomes are graft function measured with the BETA-2 score one month after the last islet injection, and IGLS graft-success assessments at one and two years. The registry’s listed intervention is a score assessment; it does not describe assigning a human extracellular-vesicle therapy. No numerical BETA-2 cutoff is endorsed here, and the record should not be read as evidence that EV treatment makes patients insulin-independent.1
Status and limits
The latest posted registry record is dated 10 September 2026 and was checked 17 September 2026. It lists not yet recruiting, an estimated September 2026 start and January 2032 completion, with no posted results. The 25-person target is not observed enrollment or an outcome denominator. No treatment efficacy or adverse-event rates can be inferred from this registration.1
The donor-islet item is linked for research context; this does not identify the study’s preparations as Lantidra or extend any product authorization. University Hospital Strasbourg is the registered sponsor. Eligibility is limited to adults with T1D on the waiting list who consent to data reuse; this review has not confirmed actual participant access.1
References
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ClinicalTrials.gov. NCT07812974, last posted update 2026-09-10; checked 17 September 2026. https://clinicaltrials.gov/study/NCT07812974 ↩ ↩2 ↩3 ↩4
Sources
- [1]NCT07812974 — Extracellular Vesicle-based Strategy to Stratify Islets and Improve Their FItness Before Transplantation · Trial registry · 2026-09-10 — Original registry description and structured fields checked 17 September 2026; no posted results. Recruitment and estimated dates are registry statements, not direct site confirmation.