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
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Incidents of hESC-RPE cell proliferation
研究概览
简要总结
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.
详细描述
Participants will be contacted by the Patient Outreach Center (POC) on an annual basis to complete a questionnaire about the occurrence of AESI, 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 AESI, 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •There are no exclusion criteria.
研究组 & 干预措施
hESC-RPE cells
Participants previously enrolled into an Astellas Institute for Regenerative Medicine (AIRM) sponsored clinical trial and treated with Human Embryonic Stem Cell-Derived Retinal Pigment Epithelial (hESC-RPE) cells
干预措施: Human Embryonic Stem Cell-Derived Retinal Pigment Epithelial Cells (Biological)
结局指标
主要结局
Incidents of hESC-RPE cell proliferation
时间窗: 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.
Number of adverse events (AEs) that are ophthalmologic, neurologic, infectious or hematologic
时间窗: 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
时间窗: 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
时间窗: Up to 15 Years
Any new cancer, irrespective of prior history, will be participant self-reported via an annual questionnaire.
Number of reported pregnancy outcome(s)
时间窗: Up to 15 Years
Occurrence of pregnancy outcomes will be participant self-reported via an annual questionnaire
Incidents of ectopic tissue (RPE or non-RPE) formation
时间窗: 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
时间窗: Up to 15 Years
Occurrence of pregnancy will be participant self-reported via an annual questionnaire
All cause death
时间窗: Up to 15 Years
All causes of death will be collected via an annual questionnaire (through participant-designated secondary contacts)
次要结局
未报告次要终点