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

Age-Related Macular Degeneration Clinical Trial

Official title:

Production of Patient Autologous Induced Pluripotent Stem Cell-derived Retinal Cells for Age-related Macular Degeneration

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05991986
• Other study ID #: 2023KYPJ224
• Status: Not yet recruiting
• Start date: August 2023
• Est. completion date: July 31, 2026

Study information

• Verified date: August 2023
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Wenjing Yin
• Phone: 020-87330290
• Email: wenjingyina[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	somatic cell collection	somatic cell collection	2023.8.1~2026.7.31