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Clinical study of subretinal transplantation of clinical human embryonic stem cells derived retinal pigment epitheliums in treatment of retinitis pigmentosa diseases

Clinical study of subretinal transplantation of clinical human embryonic stem cells derived retinal pigment epitheliums in treatment of retinitis pigmentosa diseases

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000039240
Enrollment
Unknown
Registered
2020-10-22
Start date
2020-10-15
Completion date
Unknown
Last updated
2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Retinitis Pigmentosa

Interventions

experimental group:retinal pigment epithelium transplantation

Sponsors

Institute of Zoology, Chinese Academy of Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age above 18 and under 80 years of age, both gender, in good health. 2. Clinical diagnosis of retinitis pigmentosa, the results of eye electrophysiological examination accord with retinitis pigmentosa. 3. The BCVA of target eye will not be better than 20/400. 4. The BCVA of contralateral eye is not worse than 20/400. 5. 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

Exclusion criteria: 1. Subject with other additional retinal diseases, like diabetic or hypertensive retinopathy vascular diseases. 2. Target eye ever have had a eye surgery; 3. 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; 4. Have been ready for pregnancy during test, are lactating women; 5. Ready to birth of men during the test; 6. Subject with any immunodeficiency; 7. Subject in the immunosuppressive therapy in the current; 8. Subject with the tacrolimus or other large ring lactone class drug allergies; 9. Participate in any clinical subjects in nearly six months; 10. Has a history of alcohol or illicit drug abuse; 11. Poor adherence to complete studies; 12. 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.).

Design outcomes

Secondary

MeasureTime frame
Early treatment of diabetic retinopathy eye chart (ETDRs);Best corrected visual acuity;Fluorescein angiography;Optical coherent tomography (OCT);mutifocal electroretinogram (MFERG);Flash electroretinogram (FERG);autofluorescence fundus image;

Countries

China

Contacts

Public ContactZhou Qi

Institute of Zoology, Chinese Academy of Sciences

zhouqi@ioz.ac.cn+86 10 64807299

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026