Astellas Institute for Regenerative Medicine Safety Surveillance Study
Research type
Research Study
Full title
A Safety Surveillance Study of Events of Special Interest Occurring in Subjects with Macular Degenerative Disease Treated with Human Embryonic Stem-Cell Derived Retinal Pigment Epithelial Cell Therapy
IRAS ID
239878
Contact name
James Bainbridge
Contact email
Sponsor organisation
Astellas Institute for Regenerative Medicine, LLC
Eudract number
2016-005245-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
60 years, 0 months, 1 days
Research summary
This is a safety surveillance study to evaluate the occurrence of late onset (i.e., greater than 5 years after treatment) safety events of special interest in subjects who have received sub-retinal transplant of human embryonic stem cell-derived retinal pigment epithelial cell (hESC-RPE cells). The events of special interest are adverse events (AEs) that are presumed to have a potential causal relationship to the hESC-RPE cells. Approximately 12 patients, who were previously treated with hESC-RPE cells will be enrolled into the study and will complete an annual health questionnaire either online or by phone. Participation in this study will be life-long.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
18/LO/0437
Date of REC Opinion
5 Jun 2018
REC opinion
Further Information Favourable Opinion