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

Condition(s) studied

Investigational drug(s) / intervention(s)

Human Embryonic Stem Cell-Derived Retinal Pigment Epithelial Cells: Participants who have received sub-retinal transplant of hESC-RPE cells in an AIRM sponsored clinical trial

Study summary

The purpose of this study is to is to evaluate the occurrence of late onset (i.e., greater than 5 years after treatment) adverse events of special interest (AESI) in participants who have received sub-retinal transplant of human embryonic stem cell derived - retinal pigment epithelial (hESC-RPE) cells in an AIRM-sponsored clinical trial. The events of special interest are adverse events (AEs) that are presumed to have a potential causal relationship to the hESC-RPE cells.

Eligibility

Primary outcome measure(s)

• Number of adverse events (AEs) that are ophthalmologic, neurologic, infectious or hematologic — Up 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 disorder — Up 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 history — Up to 15 Years
  Any new cancer, irrespective of prior history, will be participant self-reported via an annual questionnaire.
• Incidents of hESC-RPE cell proliferation — Up 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) formation — Up 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 partner — Up 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 death — Up to 15 Years
  All causes of death will be collected via an annual questionnaire (through participant-designated secondary contacts)

Trial sites (2)