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NCT03167203

A Safety Surveillance Study in Subjects With Macular Degenerative Disease Treated With Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy

Enrolling by Invitation
PHASE1Ages 18+InterventionalTreatment
Astellas Institute for Regenerative Medicine
~36 participants
Updated 2026-07-13 on ClinicalTrials.gov
What's tested:Human Embryonic Stem Cell-Derived Retinal Pigment Epithelial Cells

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of adverse events (AEs) that are ophthalmologic, neurologic, infectious or hematologic
Measured over Up to 15 Years
+7 more outcomes measured

Conditions

Macular Degenerative Disease

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Where it's being run

2 sites across 2 states
Missouri1
United Kingdom1

Study leadership

  • Medical Monitor · STUDY_DIRECTOR · Astellas Institute for Regenerative Medicine

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant was treated with hESC-RPE cell therapy in an Astellas Institute for Regenerative Medicine (AIRM) sponsored clinical trial in macular degenerative disease.
Participant is able to understand.

What this trial measures

  • Number of adverse events (AEs) that are ophthalmologic, neurologic, infectious or hematologicUp to 15 Years

    Adverse events (AEs) will be coded using Medical Dictionary for Regulatory Activities (MedDRA). Participant self-reported via an annual questionnaire of adverse events that are ophthalmologic, neurologic, infectious or hematologic.

  • Number of new diagnoses of an immune-mediated disorderUp to 15 Years

    Any new diagnosis of an immune-mediated disorder will be participant self-reported via an annual questionnaire.

  • Incidents of new cancer, irrespective of prior historyUp to 15 Years

    Any new cancer, irrespective of prior history, will be participant self-reported via an annual questionnaire.

  • Incidents of hESC-RPE cell proliferationUp to 15 Years

    Occurrence of human embryonic stem cell derived - retinal pigment epithelial (hESC-RPE) cell proliferation will be participant self-reported via an annual questionnaire.

  • Incidents of ectopic tissue (RPE or non-RPE) formationUp to 15 Years

    Occurrence of ectopic tissue (retinal pigment epithelial \[RPE\] or non-RPE) will be participant self-reported via an annual questionnaire

  • Number of participant reported pregnancies or pregnancy of participant's partnerUp to 15 Years

    Occurrence of pregnancy will be participant self-reported via an annual questionnaire

  • Number of reported pregnancy outcome(s)Up to 15 Years

    Occurrence of pregnancy outcomes will be participant self-reported via an annual questionnaire

  • All cause deathUp to 15 Years

    All causes of death will be collected via an annual questionnaire (through participant-designated secondary contacts)