A Multicentre Australian Phase 2 Study to Evaluate Safety and Efficacy of Mesenchymal Stromal Cells for Treating Biologic Refractory Crohn's Disease
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Clinical response to MSC: Reduction of Crohn's disease Activity score by 100 points or more at six weeks post start of therapy
研究概览
简要总结
Despite the advent of newer biologic therapies such as infliximab for Crohn's disease, a form of autoimmune inflammatory bowel disease, a proportion of patients are refractory to such therapy and require surgery. The hypothesis is that mesenchymal stromal cell therapy using third party human cultured cells will be safe and effective
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Colonic or small bowel Crohn's disease based on endoscopic appearances and histology
- •Refractory to induction with infliximab or adalimumab; or have lost response to these agents; or have had side effects precluding their further use
- •Where there has been loss of response to one of these agents, the other must be tried before being eligible
- •Crohn's disease activity score (CDAI) 250 or more.
- •C-reactive protein >10mg/L
- •Surgery must have been offered to the subject (if appropriate) and declined
- •Signed informed consent
排除标准
- •Active sepsis, perforating disease. Coexistent perianal fistulous disease is permitted, providing no co-existent infection within previous 4 weeks
- •Chronic stricturing disease in isolation
- •Coexistent CMV disease
- •Prior history of malignancy
- •Pregnant or unwilling to practice contraceptive therapy or breast feeding females
- •Last biologic therapy must be greater than 4 weeks prior, must be on stable corticosteroid dose for 14 days prior, during therapy and for 14 days after therapy, must be on stable immunomodulator dose (eg, azathioprine) for 14 days prior, during therapy and for 14 days after.
研究组 & 干预措施
Mesenchymal stromal cells
Mesenchymal stromal cells administered weekly for 4 weeks
干预措施: Mesenchymal stromal cells (MSC) for infusion (Drug)
结局指标
主要结局
Clinical response to MSC: Reduction of Crohn's disease Activity score by 100 points or more at six weeks post start of therapy
时间窗: Six weeks
Colonoscopy and biopsy as well as clinical parameters used for the Crohn's disease acivity (www.ibdaustralia.org/cdai/) will be undertaken at screening pre-therapy and at 6 weeks after start of therapy.
次要结局
- Incidence of infusional toxicity(Six weeks)
- Induction of remission(Six weeks)
- Improved quality of life(Six weeks)
- Endoscopic improvement.(Six weeks)
研究者
R.P.Herrmann
Director Cell and Tissue Therapies Western Australia
Royal Perth Hospital