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Can stem cells save sight? new trial tests eye cell transplant for dry AMD

NCT ID NCT04627428

Disease control Sponsor: Luxa Biotechnology, LLC 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether transplanting lab-grown retinal cells (RPESC-RPE-4W) into the eye is safe for people with dry age-related macular degeneration (AMD), a leading cause of vision loss. About 18 adults over 55 will receive the transplant and be monitored for side effects like vision decline, inflammation, or tumor growth. The goal is to see if the procedure is safe enough to study further as a potential treatment.

What this could mean

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

Active substance
RPESC-RPE-4W (retinal pigment epithelium stem cell-derived cells)
What this could lead to
If successful, this could point toward a cell-based treatment to slow or stop vision loss in dry AMD.
What could go wrong
This is an early-phase trial with only 18 participants, so results may not apply broadly. Risks include vision loss, inflammation, or tumor formation.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 18 people

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

Started

Apr 2022

Expected to finish

Dec 2026

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

55 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: 1. Clinical diagnosis of dry AMD. 2. Ability to understand and give informed consent. 3. Adult male or female \>55 years of age. 4. Medically suitable to undergo vitrectomy and subretinal injection (\>60% on Karnofsky scale). 5. Postmenopausal if female (expected to be common for the age limitation), or the female partner of a male subject unable to father children. 6. If male, willing to use barrier and spermicidal contraception during the study. Exclusion Criteria: 1. Allergy or hypersensitivity to dilation drops or fluorescein. 2. Active major medical conditions limiting ability to participate in the study. 3. Active malignancy or treatment with chemotherapy. 4. Systemic immunosuppressant therapy within past six months. 5. History of toxoplasmosis, retinal histoplasmosis or tuberculosis. 6. Receipt of investigational product (IP) in a clinical trial within prior six months. 7. Any other medical condition, which, in the Investigator's judgment, will interfere with the subject's ability to comply with the protocol, compromises subject safety, or interferes with the interpretation of the study results. 8. Pregnant or nursing females.

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Conditions

The condition(s) this trial relates to.

dry age related macular degeneration

As listed by the trial registrant

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

Dry age-related macular degeneration

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. 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

  • Retina Vitreous Associates Medical Group

    RECRUITING

    Beverly Hills, California, 90211, United States

  • Spencer Center for Vision Research

    RECRUITING

    Palo Alto, California, 94303, United States

  • University of Michigan Kellogg Eye Center

    RECRUITING

    Ann Arbor, Michigan, 48105, United States

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