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Stem cell eye transplant aims to halt blindness from rare genetic disease

NCT ID NCT03944239

Disease control Sponsor: Qi Zhou Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study tests whether transplanting lab-grown retinal cells (derived from human embryonic stem cells) into the back of the eye can safely slow or improve vision loss in people with retinitis pigmentosa, a genetic condition that causes gradual blindness. Participants must have severe vision loss in one eye but some remaining vision in the other. The trial will monitor for side effects and measure changes in eyesight over one year.

What this could mean

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

Active substance
human embryonic stem cell derived retinal pigment epithelium cells
What this could lead to
If successful, this approach could slow or partially reverse vision loss in people with retinitis pigmentosa.
What could go wrong
This is an early Phase 1 trial with only 25 participants, so safety and effectiveness are not yet proven. Risks include inflammation, retinal detachment, or no improvement in vision.

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 25 people

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

Started

May 2021

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

18 to 80 years

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 above 18 and under 80 years of age, both gender, in good health. * Clinical diagnosis of retinitis pigmentosa, the results of eye electrophysiological examination accord with retinitis pigmentosa. * The BCVA of target eye will not be better than 20/400. * The BCVA of contralateral eye is not worse than 20/400. * Diopter is smaller than 8.00 D, axial 28 mm or less. * Voluntary as test subjects, signed informed consent, regular follow-up will be effected according to the specified time. Exclusion Criteria: * Subject with other additional retinal diseases, like diabetic or hypertensive retinopathy vascular diseases. * Target eye ever have had a eye surgery; * Subject with active serious diseases of the digestive system, liver kidney impairment (ALT/AST) \> 1.5 or any known liver disease, creatine \> 1.3 mg/dL) and/serious temic diseases, such as cardiovascular tem, respiratory tem, nervous tem, endocrine tem urogenital tem diseases, etc.), the history of malignancy; * Have been ready for pregnancy during test, are lactating women; * Ready to birth of men during the test; * Subject with any immunodeficiency; * Subject in the immunosuppressive therapy in the current; * Subject with the tacrolimus or other large ring lactone class drug allergies; * Participate in any clinical subjects in nearly six months; * Has a history of alcohol or illicit drug abuse; * Poor adherence to complete studies; * Researchers believe that there may be an increased risk subjects or interfere with the clinical trials of any situation (such as when a patient is prone to mental tension, depression, mental illness, cognitive dysfunction, etc.).

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Conditions

The condition(s) this trial relates to.

retinitis pigmentosa

As listed by the trial registrant

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

Retinitis pigmentosa

Contacts and locations

Locations

  • Beijing Tongren Hospitol,Capital Medical University

    Beijing, Beijing Municipality, 100730, China

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