Active — Not RecruitingPhase 1

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

China25 participantsStarted 2021-05-19

Plain-language summary

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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 sub…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Adverse events and serious adverse events occurred within 1 year after transplantation

Timeframe: one year

Trial details

NCT IDNCT03944239

SponsorQi Zhou

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2026-12-31

View on ClinicalTrials.gov More Retinitis Pigmentosa trials