A Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Durability and Retreatment Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Maintenance and Re-induction of Clinical Benefit and Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 58
- 主要终点
- Re-induction of clinical benefit (Crohn's disease activity index)
研究概览
简要总结
Protocol 610 is enrolling subjects who successfully achieved clinical benefit (reduction in Crohn's Disease Activity Index (CDAI) of at least 100 points) in Protocol 603. Protocol 610 is evaluating the length of initial effect of PROCHYMAL® adult human mesenchymal stem cells and the ability of these cells to successfully re-induce clinical benefit.
详细描述
A significant number of individuals with Crohn's disease do not find relief with existing steroidal, immunosuppressive, or biologic therapies, and are forced to seek surgery or other drastic measures for treatment.
PROCHYMAL® adult human stem cells are manufactured from healthy, volunteer donors, extensively tested, and are stored to be available as needed. Human and animal studies have shown that the cells do not require any donor-recipient matching. The cells may have both immunosuppressive and healing benefits in Crohn's disease. The cells naturally migrate specifically to sites of inflammation, so their effects are believed to be local and self-limiting rather than systemic.
Protocol 610 is an extension study offered only to those subjects who successfully achieved clinical benefit (reduction of CDAI of at least 100 points) in Protocol 603.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in Osiris Protocol 603, with drop of at least 100 points in CDAI at Day 28
排除标准
- •Substance abuse
- •Failure to receive full dose of all interventions in Protocol 603
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
PROCHYMAL Low dose
Low dose (total of 600 million cells).
干预措施: PROCHYMAL adult human mesenchymal stem cells (Drug)
PROCHYMAL High dose
High dose (total of 1200 cells).
干预措施: PROCHYMAL adult human mesenchymal stem cells (Drug)
结局指标
主要结局
Re-induction of clinical benefit (Crohn's disease activity index)
时间窗: 6 months
Duration of clinical benefit (Crohn's disease activity index)
时间窗: 6 months
次要结局
- Improvement in quality of life (Inflammatory Bowel Disease Questionnaire [IBDQ] instrument)(6 months)