Extension Study to Assess the Long-Term Safety in Recipients Who Previously Received Medeor's Cellular Immunotherapy Products
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Safety Endpoints
研究概览
简要总结
At the completion of primary follow-up of various Medeor Transplant studies (called parent studies), subjects receiving Medeor's cellular immunotherapy products will be followed annually for up to an additional 84 months (7 years), in order to evaluate for long-term safety.
详细描述
Study MDR-105-SAE is intended to be the long-term safety monitoring extension of Medeor's cellular immunotherapy, kidney transplant clinical studies. This Master Protocol has been created in order to establish a single database for all long-term safety data for those subjects that have received Medeor's cellular products. This Master Protocol will provide up to 84 months (7 years) of additional follow-up.
Long-term safety of subjects treated with Medeor's cellular immunotherapy has not been assessed. This study will collect the data into a centralized database allowing for continuous monitoring of any important safety signals.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
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
- •Able and willing to fully comply with all study procedures and restrictions.
- •Able to understand and provide written, signed, and dated informed consent to participate in the study in accordance with ICH GCP Guideline and all applicable local regulations.
- •Have previously completed a Medeor study and received a Medeor cellular immunotherapy product
排除标准
- •Has any condition or circumstance, which in the opinion of the Investigator would significantly interfere with the subject's protocol compliance or put the subject at increased risk.
- •Unable or unwilling to provide written, signed, and dated informed consent to participate in the study.
- •Has undergone a second organ transplant with an organ derived from an individual other than the donor of the transplant kidney received during a Medeor study.
研究组 & 干预措施
Observational, long-term safety follow-up of patients who have received MDR product
Only patients who have received treatment with MDR product will be eligible for this study.
干预措施: MDR product (Drug)
结局指标
主要结局
Safety Endpoints
时间窗: Through study completion, up to 7 years
Incidence of serious adverse events (SAEs), adverse events (AEs) leading to study withdrawal, and hospitalizations.
次要结局
未报告次要终点