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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат 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

Первичные конечные точки

• Number of adverse events (AEs) that are ophthalmologic, neurologic, infectious or hematologic [Срок оценки: Up to 15 Years]
• Number of new diagnoses of an immune-mediated disorder [Срок оценки: Up to 15 Years]
• Incidents of new cancer, irrespective of prior history [Срок оценки: Up to 15 Years]
• Incidents of hESC-RPE cell proliferation [Срок оценки: Up to 15 Years]
• Incidents of ectopic tissue (RPE or non-RPE) formation [Срок оценки: Up to 15 Years]
• Number of participant reported pregnancies or pregnancy of participant's partner [Срок оценки: Up to 15 Years]
• Number of reported pregnancy outcome(s) [Срок оценки: Up to 15 Years]
• All cause death [Срок оценки: Up to 15 Years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• There are no exclusion criteria.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Private Practice — Kansas City

Великобритания · 1 центр

• Site GB44001 — London

Идентификаторы

NCT: NCT03167203 · 7316-CL-0007 · 2016-005245-23 · RPE-SSS-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗