NCT03944239Active, not recruitingPhase 1
Safety and Efficacy of Subretinal Transplantation of Clinical Human Embryonic Stem Cell Derived Retinal Pigment Epitheliums in Treatment of Retinitis Pigmentosa
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 27 Dec 2018
- Start date
- May 2021
- Primary completion date
- Dec 2026
- Lead sponsor
- Qi Zhou
- Diseases
- Retinitis pigmentosa
- NCT number
- NCT03944239
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 25
- From May 2021 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Target eye ever have had a eye surgery;
- Subject in the immunosuppressive therapy in the current;
Other illness
- Subject with other additional retinal diseases, like diabetic or hypertensive retinopathy vascular diseases.
- Subject with the tacrolimus or other large ring lactone class drug allergies;
- Has a history of alcohol or illicit drug abuse;
- 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.).
Lab values
- 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;
Other
- Have been ready for pregnancy during test, are lactating women;
- Ready to birth of men during the test;
- Subject with any immunodeficiency;
- Participate in any clinical subjects in nearly six months;
- Poor adherence to complete studies;
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Tongren Hospitol,Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.