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

General Information

Summary The purpose of this study is to is to evaluate the occurrence of late onset (i.e., greater than 5 years after treatment) safety events of special interest 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.
Description Participants will be contacted by the Patient Outreach Center (POC) on an annual basis to complete a questionnaire about the occurrence of safety events of special interest, as defined in the Outcome Measure section. The questionnaire will be completed directly by the participant (via a secure web based platform) or will be administered via telephone by a POC staff member. In the event of the occurrence of a safety event of special interest, study participant will be encouraged to contact the POC as soon as possible, rather than wait for the annual questionnaire completion. Follow up data is inclusive of the 1 year in the core trial, 4 years in the long term follow up trial and 10 years in this long term safety follow up. Participation for United Kingdom participants will be life-long.
Clinical trials phase Long term follow up
Start date (estimated) 2018-01-08
End date (estimated) 2029-12-31
Clinical feature
Label Macular Degeneration
Link http://purl.obolibrary.org/obo/NCIT_C123330
Description Loss of vision in the central portion of the retina (macula), secondary to retinal degeneration.

Administrative Information

NCT Number NCT03167203
EudraCT Number 2016-005245-23
Other study identifiers
Name 7316-CL-0007
Name RPE-SSS-001
Description (Other Identifier: Sponsor)
Source weblink https://clinicaltrials.gov/ct2/show/NCT03167203
Regulatory body approval
Country
Public contact
Country
Sponsors Astellas Pharma Inc.

Cell Line

Recruitment

Recruitment Status Enrolling by invitation
Estimated number of participants 36