NCT01510431No Longer Available不适用
An Open-label Compassionate Treatment Protocol to Evaluate the Safety and Treatment Outcomes of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- No Longer Available
- 试验地点
- 4
研究概览
简要总结
Protocol 620 provides PROCHYMAL(R) adult human mesenchymal cells to specifically chosen Crohn's disease patients at participating centers who typically have already demonstrated good response in another PROCHYMAL study, are not eligible for other PROCHYMAL studies, and in the view of the investigator, would not benefit significantly from other Crohn's therapies but would benefit from use of PROCHYMAL.
The study is not placebo-controlled or randomized.
研究设计
- 研究类型
- Expanded Access
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
- •currently active moderate-to-severe Crohn's disease
- •exhausted standard-of-care options
- •age 18 to 70 inclusive
- •body weight between 30 and 150 kg
- •adequate renal function
- •not at risk for tuberculosis (TB) activation or re-activation
排除标准
- •biologic therapy for Crohn's within last 8 weeks
- •confirmed adverse reactions during prior PROCHYMAL study participation
- •alcohol or substance abuse, current or within past 6 months
- •active HIV or hepatitis B or C infection
- •surgery or trauma with 6 weeks
- •allergy to bovine or porcine products
- •elevated serum liver enzymes
- •elevated serum bilirubin
- •active malignancy within 5 years (other than some resected skin cancers)
- •bacteremia or other serious bacterial or fungal infection within 3 months
- •colonic dysplasia
- •unstable arrhythmia or serious heart condition
研究者
研究点 (4)
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