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Stem cell eye treatment could restore sight in retinal disease patients

NCT ID NCT06789445

Disease control Sponsor: BlueRock Therapeutics 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 20, 2026 · Updated 5 times

Summary

This study tests a new treatment called OpCT-001 for people with inherited eye diseases that damage the retina, such as retinitis pigmentosa. The treatment involves injecting special photoreceptor cells, made from stem cells, into the back of the eye to replace lost cells. The trial will enroll 54 adults and first check safety, then see if it improves vision.

What this could mean

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

Active substance
OpCT-001 (photoreceptor precursor cells made from stem cells)
What this could lead to
If it works, this could slow or reverse vision loss in people with inherited retinal diseases, potentially restoring some sight.
What could go wrong
This is an early, first-in-human trial with only 54 people. The cells may not survive or integrate, and there are risks from surgery and immune reactions.

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 54 people

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

Started

Mar 2025

Expected to finish

Oct 2030

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.

Key Inclusion Criteria: * Confirmed genetic diagnosis of primary photoreceptor (PR) disease * Best corrected visual acuity (BCVA) in the study eye at Screening for Phase 1: Logmarithm of the minimum angle of resolution (LogMAR) 3.9 to LogMAR 1.3. BCVA at Screening for Phase 2: ETDRS letter score between 20 to 60, inclusive. * Retinal structure examination in the study eye demonstrating regions suitable for cell administration. Key Exclusion Criteria: * Clinically relevant, active ocular inflammation or infection * Glaucoma or other significant optic neuropathy * Diabetic macular edema or diabetic retinopathy * Clinically significant cystoid macular edema * In phakic participants: Spherical equivalent refractive error of greater than 8.00 diopters myopia * Ocular surgery ≤3 months before Screening * Monocular vision (ie, no light perception in the fellow eye) * Currently active malignancy, or history of malignancy within 5 years before OpCT-001 administration. Exception: Basal cell carcinoma that has been definitively treated. * Any current and active infection (bacterial/viral/fungal) that could put the participant at risk from immunosuppression * History of any cell therapy, gene therapy, or retinal implant at any time * Previously received a bone marrow or solid organ transplant

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Conditions

The condition(s) this trial relates to.

cone-rod dystrophy inherited retinal dystrophy retinal degeneration retinitis pigmentosa Usher syndrome

As listed by the trial registrant

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

Cone-rod disease Cone-rod disease (C-RD) Cone-rod dystrophy Inherited retinal disease (IRD) Primary photoreceptor disease Retinal degeneration Retinitis pigmentosa (RP) Rod cone dystrophy Rod-cone disease Usher syndrome

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    5 sites. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Mid Atlantic Retina/ Wills Eye

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

    Contact Email: •••••@•••••

  • Retina Foundation of the Southwest

    RECRUITING

    Dallas, Texas, 75231, United States

    Contact Email: •••••@•••••

  • University of Miami, Bascom Palmer Eye Institute

    RECRUITING

    Miami, Florida, 33136, United States

    Contact Email: •••••@•••••

  • University of Southern California /Children's Hospital of Los Angeles

    RECRUITING

    Los Angeles, California, 90007, United States

    Contact Email: •••••@•••••

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53705, United States

    Contact Email: •••••@•••••

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