Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 50 to 85

Transplanting hiPSC-derived RPE Cells for Advanced AMD

Official title: Study in Human iPSCs-derived Retinal Pigment Epithelium Cells Transplantation for Advanced (Late-stage) Age-Related Macular Degeneration

Run by The First Affiliated Hospital with Nanjing Medical University · NCT07418177 · Data updated 2026-11-12

This trial tests whether transplanting lab-made retinal pigment epithelium cells can help people aged 50–85 with late-stage AMD see if their condition improves or stabilizes.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages50 Years to 85 Years
SexAll
Enrollment12 (estimated)
SponsorThe First Affiliated Hospital with Nanjing Medical University
Academic / other
Drugs / interventionsRanibizumab, Bevacizumab
Locations1 site (Nanjing, Jiangsu)
StatusRecruiting
StartedOctober 14, 2025
Main results expectedDecember 31, 2028
Study endsDecember 31, 2028
Registry record updatedOctober 19, 2026
Trial IDNCT07418177 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults aged 50–85 with late-stage AMD, either geographic atrophy involving the fovea or inactive neovascular AMD with a fibrovascular scar and no macular edema.

Probably not a fit

Patients with active ocular inflammation, significant retinal issues beyond the study eye, or unsuitable retinal anatomy may not benefit.

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

What this trial studies

This Phase 1/2 interventional study enrolls adults with advanced AMD to receive subretinal transplants of human iPSC-derived RPE cells. The goal is to assess safety and gather early signals of efficacy for geographic atrophy or inactive neovascular AMD. Participants receive the hiPSC-RPE transplant in the affected eye, with BCVA and retinal structure monitored over time. Eligibility focuses on macular atrophy, scarred non-exudative AMD, and specific eye health parameters to minimize risk. The study is led by The First Affiliated Hospital with Nanjing Medical University, with HELP Therapeutics Co., Ltd. as a collaborator; recruitment is limited to a site in Nanjing, China.

Why it matters

Potential benefit: If successful, patients may experience stabilization or improvement in vision and better preservation of macular structure.

How similar studies have gone: Previous trials using stem cell–derived RPE or related cell therapies have shown safety signals and some functional hints, but results vary by approach and remain exploratory.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* (1)Age ≥50 years and ≤85 years, regardless of gender.
* (2)Patients with atrophic AMD in the macular area (geographic atrophy \>250μm, involving the foveal center); or inactive neovascular AMD patients who have undergone treatment for wet AMD or have naturally converted to non-exudative AMD (referring to patients with fibrovascular scar formation, who are unresponsive to anti-VEGF treatment, and have no macular edema on OCT and/or no fluorescein leakage on FFA), with a scar diameter not exceeding 6 PD.
* (3)Best-corrected visual acuity (BCVA) of the study eye ≥5 letters and ≤34 letters (using the ETDRS visual acuity chart).
* (4)If both eyes meet the criteria, the more severely affected eye will be selected; if the severity is the same in both eyes, the right eye will be designated as the study eye.
* (5)The patient or their legal representative has signed a written informed consent form.

Exclusion Criteria:

* Ocular Diseases:
* (1)Vitreous hemorrhage in the study eye within 2 months prior to screening.
* (2)Presence of a scar or fibrosis involving the fovea in the study eye, or a peripheral scar area greater than 6 PD, indicating severe irreversible visual loss.
* (3)Presence of pseudoexfoliation syndrome, central retinal vein occlusion, intraocular hemorrhage causing visual loss, rhegmatogenous retinal detachment, macular hole, or active choroidal neovascularization in the study eye.
* (4)Afferent pupillary defect (APD) in the study eye.
* (5)Significant media opacity in the study eye (excluding lens opacities) that may interfere with visual function assessment or fundus examination.
* (6)Acute infectious inflammation in either eye during the screening period.
* (7)Patients with intraocular pressure higher than 25 mmHg despite medical treatment.
* (8)Monocular blind patients.

Ocular Treatments:

* (9)The study eye has undergone focal/grid laser photocoagulation within 3 months prior to screening.
* (10)The study eye has undergone any intraocular surgery within 3 months prior to screening.
* (11) Any eye has received anti-angiogenic therapy (including any anti-VEGF agents, e.g., Aflibercept \[Eylea®\], Ranibizumab \[Lucentis®\], Bevacizumab \[Avastin®\]) within 1 month prior to screening; or has undergone cataract surgery within 1 month prior to screening with unstable postoperative ocular conditions.

Systemic Diseases, Treatments, and Other Conditions:

* (12)Patients with an allergic reaction or history of allergy to sodium fluorescein and indocyanine green, a history of allergy to protein products used for treatment or diagnosis, and patients with allergies to two or more drugs and/or non-drug factors, or those currently suffering from allergic diseases.
* (13)Patients with uncontrolled diabetes (fasting blood glucose ≥7.0 mmol/L or 2-hour postprandial blood glucose ≥11.1 mmol/L).
* (14)Patients with a history of surgical procedures within 1 month prior to screening, or those with unhealed wounds, ulcers, fractures, etc.
* (15)Patients with uncontrolled hypertension (defined as a single measurement of systolic blood pressure \>180 mmHg, two consecutive measurements of systolic blood pressure \>160 mmHg, or diastolic blood pressure \>100 mmHg despite optimal treatment).
* (16)Patients with a history of myocardial infarction within 6 months prior to enrollment.
* (17)Patients with active disseminated intravascular coagulation or a significant tendency to bleed; patients who have used anticoagulant or antiplatelet aggregation drugs within 14 days prior to screening, except for aspirin/nonsteroidal anti-inflammatory drugs.
* (18) Presence of any uncontrolled systemic clinical conditions, such as interstitial pneumonia, severe psychiatric, neurological, cardiovascular, or respiratory diseases, malignant tumors, Parkinson's disease, Alzheimer's disease, or other severe systemic disorders.
* (19)Women of childbearing age with a positive pregnancy test during the screening period. Women who wish to breastfeed during the study period, and all patients of childbearing age (male and female) who do not agree to take effective contraceptive measures (such as intrauterine devices, oral contraceptives, or condoms) throughout the study period and for 30 days after the end of the visit period.
* (20)Patients who have participated in or are currently participating in other clinical studies within 30 days prior to screening.
* (21)Hemoglobin \<100 g/L, platelets ≤100×10\^9/L, neutrophil count \<1.0×10\^9/L, ALT/AST \>1.5×upper limit of normal (ULN), creatinine \>1.3 mg/dL.
* (22)Subjects with any clinically significant finding in virological tests (HIV, HBV, HCV and TPPA).
* (23)Patients deemed unsuitable for inclusion by the investigator, or other medical conditions that limit the subject's compliance, safety, or affect the results of the trial results.

Where it's running

  • The First Affiliated Hospital with Nanjing Medical University
    Nanjing, Jiangsu, China
    Recruiting

Study contacts

  • Principal investigator: Songtao Yuan, M.D. — The First Affiliated Hospital with Nanjing Medical University
  • Study coordinator: Songtao Yuan, M.D.
  • Email: songtaoyuan@njmu.edu.cn
  • Phone: +86159-5108-8899

Similar studies

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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.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.