Retinitis PigmentosaPhase 1NCT03944239

Safety and Efficacy of Subretinal Transplantation of Clinical Human Embryonic Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Retinitis Pigmentosa

A Phase 1 study testing Retinal pigment epitheliums transplantation in people with Retinitis Pigmentosa, run by Qi Zhou at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Retinitis Pigmentosa
What is being tested?: Retinal pigment epitheliums transplantation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteChina
Study dates: 19 May 2021to 31 Dec 2026
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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.).

Trial locations and contacts

1 site in 1 country.

China1 site

Beijing Tongren Hospitol,Capital Medical University
Beijing, Beijing Municipality, 100730

Other trials in China

About this study

This project intends to transplant a clinical level human embryonic stem cells derived retinal pigment epithelium into subretinal space to treat eetinitis pigmentosa(RP) diseases. Through the statistical analysis EDTRS, BCVA, OCT, ERG, Fluorescein angiography, Ophthalmic AB ultrasound changes between before and after the treatment to assess the efficacy and safety 0f RPE transplants to treat RP disease.

Read the detailed description

Conditions: Retinitis Pigmentosa
Being tested: Retinal pigment epitheliums transplantation
Medical subject headings: Retinitis Pigmentosa

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Retinal pigment epitheliums transplantationBiological
Subretinal transplantation of clinical human embryonic stem cell derived retinal pigment epitheliums.

Study groups in NCT03944239
Study group	Role	What they receive
retinal pigment epitheliums transplantation	Experimental	Transplant clinical-grade hESC derived retinal pigment epitheliums into subretinal of patients with retinitis pigmentosa.The dosage is 150000. Receives: Biological: Retinal pigment epitheliums transplantation

What is being measured

The primary outcome is the main question the study is designed to answer.

Adverse events and serious adverse events occurred within 1 year after transplantation
The occurrence of adverse events (AE), severe adverse events (SAE), treatment-related adverse events (TEAE), and clinically significant vital signs during the study period.
Measured: one year

Secondary outcomes (1)

Improvement of visual function
The changes of BCVA and EDTRS were observed one year after surgery.
Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 May 202131 Dec 2026

First posted9 May 2019
Study start19 May 2021
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 25 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03944239
Sponsor's protocol ID: ChineseASZQ-002
Status last verified: Jul 2026
First submitted: 27 Dec 2018
Last updated: 6 Jul 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Retinitis Pigmentosa trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of Subretinal Transplantation of Clinical Human Embryonic Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Retinitis Pigmentosa
ClinicalTrials.gov ID: NCT03944239
Acronym / sponsor ID: ChineseASZQ-002
Conditions: Retinitis Pigmentosa
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 25 participants (estimated)
Lead sponsor: Qi ZhouOther government
Collaborators: Beijing Tongren Hospital
Study start: 19 May 2021 (actual)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 9 May 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
retinal pigment epitheliums transplantation	Experimental	Biological: Retinal pigment epitheliums transplantationTransplant clinical-grade hESC derived retinal pigment epitheliums into subretinal of patients with retinitis pigmentosa.The dosage is 150000.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (12 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Retinal pigment epitheliums transplantationSubretinal transplantation of clinical human embryonic stem cell derived retinal pigment epitheliums.	Biological	retinal pigment epitheliums transplantation

Primary outcome

Adverse events and serious adverse events occurred within 1 year after transplantation
Time frame: one year
The occurrence of adverse events (AE), severe adverse events (SAE), treatment-related adverse events (TEAE), and clinically significant vital signs during the study period.

1 secondary outcome

Improvement of visual function
Time frame: one year

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.

Related trials for Retinitis Pigmentosa

RecruitingObservational study
Rod and Cone Mediated Function in Retinal Disease
Retinal Degeneration, Retinitis Pigmentosa
RecruitingObservational study
Cell Collection to Study Eye Diseases
Retinal Disease, AMD
Recruiting
Brain Stimulation Effects on Orientation and Mobility Skills in Adults With Vision Impairment
Retinitis Pigmentosa (RP), Rod Cone Dystrophy
RecruitingObservational study
Universal Rare Gene Study: A Registry and Natural History Study of Retinal Dystrophies Associated With Rare Disease-Causing Genetic Variants
Inherited Retinal Degeneration, Retinitis Pigmentosa
Active, not recruitingObservational study
Rate of Progression in EYS Related Retinal Degeneration
Retinitis Pigmentosa, Eye Diseases

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Zhou Qi, Doctor principal investigator

Institute of Zoology, Chinese Academy of Sciences

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Retinal pigment epitheliums transplantation in people with Retinitis Pigmentosa, run by Qi Zhou at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events and serious adverse events occurred within 1 year after transplantation (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03944239.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.