Preparation of Patient Autologous Induced Pluripotent Stem Cell-derived Retinal Cells for AMD

NCT ID: NCT05991986

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-07-31

Brief Summary

This project intends to collect participant somatic cells to prepare autologous induced pluripotent stem cell-derived retinal cells for future cell therapy of age-related macular degeneration patient.

Detailed Description

One or more types of somatic cells will be collected from every participant by collecting approximately 100~500 ml of midstream urine, 20~30 ml of peripheral blood, skin biopsies (3mm), conjunctiva biopsies (5mm×5mm), etc. Then, these somatic cells will be used to prepare patient autologous induced pluripotent stem cell-derived retinal cells for the cell therapy of age-related macular degeneration patient.

Conditions

Age-Related Macular Degeneration

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Interventions

somatic cell collection

One or more types of somatic cells will be collected from every participant by collecting approximately 100\~500 ml of midstream urine, 20\~30 ml of peripheral blood, skin biopsies (3mm), conjunctiva biopsies (5mm×5mm), etc.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Aged 55-80 years;

2. Clinical diagnosis is consistent with the definition of advanced age-related macular degeneration;

3. The BCVA of the target eye will be lower than 20/200;

4. -8.00 D < refraction < +8.00 D, 21 mm < anteroposterior axis≤ 28 mm;

5. Voluntary as test subjects, informed consent, regular follow-up on time;

6. Voluntary as test subjects to join the associated clinical research on autologous iPSC-derived retinal cell therapy for AMD (ethical approval and informed consent documents will be applied and signed separately);

Exclusion Criteria

1. Macular atrophy caused by other diseases in addition to AMD;

2. Malignant tumor and history of malignancy;

3. Any immune deficiency;

4. Lens opacities (affecting the central vision), glaucoma, uveitis, retinal detachment, inherited retinal dystrophy, optic neuropathy, and other ocular histories;

5. Other intraocular surgery histories besides cataract surgery;

6. Severe heart failure or the left ventricular ejection fraction <35% in the previous 6 months;

7. Dialysis or eGFR <20ml/min/1.73m2;

8. Urine protein/urine creatinine ratio ≥1g/g;

9. Creatinine or albumin/urine creatinine ratio ≥600mg/g;

10. Chronic liver disease with ALT three times over the upper limit of normal value;

11. Combined with severe systemic diseases, such as heart failure, liver disease, COPD, etc.

12. Combined with severe infectious diseases, such as HIV, HBV, HCV, syphilis, etc.

13. HCV-RNA positive, HBV-DNA >103 IU/ml, or TB, etc., during the infectious period;

14. Use anticoagulant, or the platelet function is still not restored to normal after stopping antiplatelet drugs for 10 days;

15. Abnormal blood coagulation function or other laboratory tests;

16. Use glucocorticoids, immunosuppressive drugs, or antipsychotic drugs in the previous 3 months;

17. Use antipsychotic drugs in the previous 3 months, such as antidepressants drugs, antimanic drugs, etc.

18. Allergy to tacrolimus or other macrolides;

19. A history of addiction to alcoholism or prohibited drugs;

20. Be participating in other intervention clinical trials or receiving other study medications;

21. Informed refusal；

22. Some other situations which might increase the risks of the subjects or interfere with clinical trials, such as mental disorders, cognitive dysfunction, etc.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xiufeng Zhong

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiufeng Zhong, Doctor

Role: STUDY_DIRECTOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Central Contacts

Wenjing Yin

Role: CONTACT

wenjingyina@163.com

020-87330290

Other Identifiers

2023KYPJ224

Identifier Type: -

Identifier Source: org_study_id