Transplanting stem cells to treat macular degeneration

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to treat refractory age-related macular degeneration by performing autologous transplantation of induced pluripotent stem cell-derived retinal pigment epithelium (iPSC-RPE). Participants aged 50-75 will have their own stem cells converted into RPE cells, which will then be injected into the subretinal space of their eyes. The safety and efficacy of this treatment will be monitored using various ophthalmic assessments before and after the procedure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged 50-75 years;
* Clinical diagnosis is consistent with the definition of late dry AMD in the age-related eye disease study (AREDS), with one or more \>250 um geographic atrophy in the fovea;
* Clinical diagnosis is wet AMD, but no obvious efficacy after conventional treatment;
* The BCVA of the target eye will be 0.05 to 0.3;
* Voluntary as test subjects, informed consent, regular follow-up on time.

Exclusion Criteria:

* One-eyed subjects;
* Macular atrophy caused by other diseases in addition to AMD;
* Suffer from retinitis pigmentosa, choroidal retinitis, central serous choroiditis, diabetic retinopathy, or other retinal vascular and degenerative diseases besides AMD;
* Lens opacities (affecting the central vision), glaucoma, uveitis, retinal detachment, optic neuropathy, and other ocular histories;
* Other intraocular surgery histories besides cataract surgery;
* Combined with severe systemic diseases, such as heart failure, liver disease, renal insufficiency, cor pulmonale, COPD in the previous 12 months;
* Combined with severe infectious diseases, such as HIV, HBV, HCV, syphilis, tuberculosis, etc;
* Abnormal blood coagulation function or other laboratory tests;
* If female and of childbearing potential, pregnant, breastfeeding, or planning to become pregnant through the study;
* If male, refuse to use barrier and spermicide contraception during the study;
* Malignant tumor and history of malignancy;
* Any immune deficiency;
* Allergy to tacrolimus or other macrolides;
* Any immune deficiency;
* Use glucocorticoids, immunosuppressive drugs, or antipsychotic drugs in the previous 3 months;
* Use anticoagulant, or the platelet function is still not restored to normal after stopping antiplatelet drugs for 10 days;
* A history of addiction to alcoholism or prohibited drugs;
* Be participating in other intervention clinical trials or receiving other study medications;
* Poor compliance, difficulty to complete the study, or refusal to informed consent;
* Some other situations which might increase the risks of the subjects or interfere with clinical trials, such as mental disorders, cognitive dysfunction, etc.

Where it's running

• Beijing Tongren Hospitol,Capital Medical University
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Xiaohui Zhang
• Email: zhangxh711@126.com
• Phone: +0086-(010)58265915

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Noninvasive imaging biomarkers to see if ophthalmic artery narrowing relates to geographic atrophy in age-related macular degeneration

  This study tests whether narrowed ophthalmic artery vessels are linked to the development or worsening of geographic atrophy in people with dry age-related macular degeneration.

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• Multimodal-feedback vision rehabilitation for people with central vision loss

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• Tiespectus (MK-8748) versus aflibercept to treat neovascular (wet) age-related macular degeneration

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• Comparing tiespectus (MK-8748) with aflibercept for wet age-related macular degeneration

  This study will test whether tiespectus (MK-8748) works as well as aflibercept for people with newly diagnosed neovascular (wet) age-related macular degeneration.

  Recruiting at 132 sites Phase 2/3 EyeBiotech Ltd. · Scottsdale, Arizona and 131 other locations · NCT07440225

• See If Faricimab Helps Neovascular Age-related Macular Degeneration

  This study tests whether Faricimab injections every month for 4 months can help adults aged 50 and older with active neovascular AMD in at least one eye.

  Recruiting at 3 sites Phase 4 Asan Medical Center · Seongnam and 4 other locations · NCT07367282

• Natural history of inherited retinal diseases

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  Recruiting Augelux Therapeutics · Wuhan · NCT07085533

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.