Age-Related Macular DegenerationNCT05991986
Preparation of Patient Autologous Induced Pluripotent Stem Cell-derived Retinal Cells for AMD
An observational study of Age-Related Macular Degeneration, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
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. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- somatic cell collection
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- Aug 2025to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: AMD patients
Who may be able to join
- 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;
- -8.00 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);
Who cannot join
- 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;
Show all 22Show fewer
- 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;
- Use glucocorticoids, immunosuppressive drugs, or antipsychotic drugs in the previous 3 months;
- Use antipsychotic drugs in the previous 3 months, such as antidepressants drugs, antimanic drugs, etc.
- Allergy to tacrolimus or other macrolides;
- A history of addiction to alcoholism or prohibited drugs;
- Be participating in other intervention clinical trials or receiving other study medications;
- Informed refusal；
- Some other situations which might increase the risks of the subjects or interfere with clinical trials, such as mental disorders, cognitive dysfunction, etc.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Production of Patient Autologous Induced Pluripotent Stem Cell-derived Retinal Cells for Age-related Macular Degeneration
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.
Read the 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
- Being tested
- somatic cell collection
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somatic cell collectionOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
somatic cell collection
somatic cell collection
Measured: 2023.8.1~2026.7.31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study startAug 2025 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiufeng Zhong, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Investigators
- Xiufeng Zhong, Doctor, Study director, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05991986
- Sponsor's protocol ID
- 2023KYPJ224
- Status last verified
- Jan 2025
- First submitted
- 26 Jul 2023
- Last updated
- 28 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Production of Patient Autologous Induced Pluripotent Stem Cell-derived Retinal Cells for Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT05991986
- Acronym / sponsor ID
- 2023KYPJ224
- Conditions
- Age-Related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AMD patients
Key inclusion criteria (6 listed)
- 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;
- -8.00 D < refraction < +8.00 D, 21 mm < anteroposterior axis≤ 28 mm;
- Voluntary as test subjects, informed consent, regular follow-up on time;
Key exclusion criteria (22 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| somatic cell collectionOne 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. | Other | – |
Primary outcome
somatic cell collection
Time frame: 2023.8.1~2026.7.31
somatic cell collection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiufeng Zhong, Doctor study director
Zhongshan Ophthalmic Center, Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related Macular Degeneration, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenjing Yin (020-87330290, wenjingyina@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
somatic cell collection (time frame: 2023.8.1~2026.7.31). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025; AzTrials last refreshed its copy on 8 Nov 2026.