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First human trial of Lab-Grown corneal implant launches

NCT ID NCT07325097

Disease control Sponsor: Precise Bio Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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-stage trial tests a new implant called PVEK for people with corneal swelling from Fuchs' dystrophy or pseudophakic bullous keratopathy. The implant uses a collagen scaffold with human corneal cells to replace damaged tissue. About 15 participants will receive the implant and be monitored for 12 months to check safety and tolerability.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PVEK corneal implant (human collagen scaffold with corneal endothelial cells)
What this could lead to
If successful, this could lead to a new treatment option for corneal swelling that reduces the need for donor tissue transplants.
What could go wrong
This is a very early Phase 1 trial with only 15 people, so it is primarily checking safety. The implant may not work well or could cause side effects like high eye pressure or rejection.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

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: age 18/50 years or older Corneal edema requiring endothelial keratoplasty due to Fuchs' endothelial dystrophy and/or pseudophakic bullous keratopathy Pseudophakic study eye Best corrected visual acuity (BCVA) in the study eye between 6/379 (1.8 logMAR) and 6/12 (0.3 logMAR) Central corneal thickness greater than 0.6 mm by OCT Exclusion Criteria: Phakic study eye Study eye is a "single sight eye" (per protocol definition) / fellow eye does not meet protocol vision requirement Malpositioned intraocular lens (dislocation/subluxation) in the study eye Prior ocular procedure in the study eye other than uncomplicated cataract surgery with a stable, centered posterior chamber IOL Axial length below 21 mm or above 26 mm Other significant corneal disease (beyond mild dry eye) or prior keratoplasty in the study eye, or visually significant corneal scarring/opacities not expected to improve with treatment Active ocular or eyelid infection/inflammation; active/prior herpetic ocular infection; uveitis Glaucoma / history or suspicion of elevated IOP, or screening IOP above 23 mmHg (either eye) Synechiae; abnormal anterior segment (e.g., aphakia, aniridia) Corneal endothelial cell density above 1000 cells/mm² at screening (or not reliably measurable) Uncontrolled systemic conditions

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Conditions

The condition(s) this trial relates to.

bullous keratopathy corneal edema Fuchs' endothelial dystrophy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Corneal edema Corneal endothelial dysfunction Fuchs' endothelial dystrophy Pseudophakic bullous keratopathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Ophthalmological Center After S.V.Malayan

    NOT_YET_RECRUITING

    Yerevan, 0048, Armenia

  • Rambam Medical Center

    RECRUITING

    Haifa, 3109602, Israel

  • Sharei Zedek Medical Center

    NOT_YET_RECRUITING

    Jerusalem, Jerusalem, abecassis, Israel

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