Safety and Efficacy of Autologous Transplantation of iPSC-RPE in the Treatment of Macular Degeneration

Safety and Efficacy of Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium in the Treatment of Macular Degeneration

Safety and Efficacy of Autologous Transplantation of iPSC-RPE in the Treatment of Macular Degeneration (NCT05445063) is a Phase 1 interventional studying Macular Degeneration, sponsored by Beijing Tongren Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

This project intends to perform autologous transplantation of induced pluripotent stem cell-derived retinal pigment epithelium (iPSC-RPE). The clinical-grade RPE will be transplanted into subretinal space to treat refractory age-related macular degeneration. The efficacy and safety of RPE transplants to treat macular degeneration will be monitored and analyzed with results from EDTRS, BCVA, OCT, ERG, microperimetry, and fluorescein angiography, before and after the treatment.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Macular Degeneration, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 10 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - 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, willing to sign a consent form, regular follow-up on time. Who Should NOT Join This Trial: - 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; ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

BIOLOGICAL

Autologous iPSC-derived RPE

Autologous transplantation of iPSC-derived RPE

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Beijing Tongren Hospitol,Capital Medical University

Beijing, Beijing Municipality, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05445063), the sponsor (Beijing Tongren Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05445063 clinical trial studying?

Who can participate in NCT05445063?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05445063?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05445063. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05445063. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.