A Safety Surveillance Study in Subjects With Macular Degenerative Disease Treated With Human Embryonic Stem Cell-derived Retinal Pigment Epithelial Cell Therapy
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/13/2019 |
| Start Date: | January 8, 2018 |
| End Date: | December 2029 |
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
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.
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.
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.
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.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- There are no exclusion criteria.
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