Clinical trial NCT05991986: Preparation of Patient Autologous Induced Pluripotent Stem Cell-derived Retinal Cells for AMD
Official title: Production of Patient Autologous Induced Pluripotent Stem Cell-derived Retinal Cells for Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Age-Related Macular Degeneration
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 10
Sex: ALL
Minimum age (years): 55
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: AMD patients

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.

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.

Primary outcomes:
measure: somatic cell collection
timeFrame: 2023.8.1~2026.7.31
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Xiufeng Zhong, Doctor
role: STUDY_DIRECTOR
References: