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Stem cell therapy for rare eye disease passes 5-year safety check

NCT ID NCT05786287

Disease control Sponsor: PT. Prodia Stem Cell Indonesia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study follows up 18 people who received umbilical cord stem cells or conditioned medium for retinitis pigmentosa, a rare eye disease that causes vision loss. Researchers will check vision, eye structure, and safety five years after the injection. The goal is to see if the treatment remains safe over the long term.

What this could mean

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

Active substance
umbilical cord mesenchymal stem cells and conditioned medium
What this could lead to
If successful, this could show that stem cell therapy is safe for long-term use in retinitis pigmentosa, possibly slowing vision loss.
What could go wrong
This is a very small, early safety follow-up with only 18 people, not designed to prove the treatment works. Risks include injection-related complications and uncertain long-term benefits.

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.

Participants

About 18 people

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

Expected to start

May 2026

An estimate. Start dates often move.

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.

Who is studied

Retinitis Pigmentosa patients who have been transplanted UC-MSC and/or CM 5 years ago under clinical trials NCT04315025

Ages

18 to 65 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: * Visual field defects at the initial examination with Humphrey perimetry are between 25% to 50% * Willing to sign informed consent as research subjects * Willing to do the peribulbar injection with mesenchymal stem cells isolated from umbilical cord tissue * Willing to do visual field checks with Humphrey's perimetry, vision tests with Snellen boards, Optical Coherent Tomography (OCT) examinations, electroretinogram examinations and fill out a quality of life questionnaire Exclusion Criteria: * Pregnant or nursing women * Positive result of HIV test * Have a history of eye tumours * In the immunosuppressive treatment or other drugs that can affect the growth of transplanted stem cells * Have another eye disease such as diabetic retinopathy, uveitis, cataract, and glaucoma * Do not come to control according to the schedule determined by the researcher (loss to follow up)

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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

How to take part

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

  1. The places running it

    2 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

  • Jakarta Eye Center Hospital

    Jakarta, DKI Jakarta, Indonesia

  • Sardjito Hospital

    Yogyakarta, Special Region, 55284, Indonesia

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