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

NCT05991986 | Not Yet Recruiting

• 1 other identifier: 2023KYPJ224
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• somatic cell collection

  somatic cell collection

  2023.8.1~2026.7.31

Interventions

somatic cell collection OTHER

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.

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

AMD patients

You may qualify if:

• Aged 55-80 years;
• Clinical diagnosis is consistent with the definition of advanced age-related macular degeneration;
• The BCVA of the target eye will be lower than 20/200;
• D \< refraction \< +8.00 D, 21 mm \< anteroposterior axis≤ 28 mm;
• Voluntary as test subjects, informed consent, regular follow-up on time;
• 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);

You may not qualify if:

• Macular atrophy caused by other diseases in addition to AMD;
• Malignant tumor and history of malignancy;
• Any immune deficiency;
• Lens opacities (affecting the central vision), glaucoma, uveitis, retinal detachment, inherited retinal dystrophy, optic neuropathy, and other ocular histories;
• Other intraocular surgery histories besides cataract surgery;
• Severe heart failure or the left ventricular ejection fraction \<35% in the previous 6 months;
• Dialysis or eGFR \<20ml/min/1.73m2;
• Urine protein/urine creatinine ratio ≥1g/g;
• Creatinine or albumin/urine creatinine ratio ≥600mg/g;
• Chronic liver disease with ALT three times over the upper limit of normal value;
• Combined with severe systemic diseases, such as heart failure, liver disease, COPD, etc.
• Combined with severe infectious diseases, such as HIV, HBV, HCV, syphilis, etc.
• HCV-RNA positive, HBV-DNA \>103 IU/ml, or TB, etc., during the infectious period;
• Use anticoagulant, or the platelet function is still not restored to normal after stopping antiplatelet drugs for 10 days;
• Abnormal blood coagulation function or other laboratory tests;

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Biospecimen

Retention: SAMPLES WITH DNA

somatic cells isolated from urine, peripheral blood, skin biopsies, conjunctiva biopsies, etc.

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Xiufeng Zhong, Doctor

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  STUDY DIRECTOR

Central Study Contacts

Wenjing Yin

CONTACT

020-87330290; wenjingyina@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 15, 2023
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: January 28, 2025

Record last verified: 2025-01