Stem Cells Treatment of Complex Crohns Perianal Fistula. A Pilot Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- healing
研究概览
简要总结
A pilot study to investigate the safety and feasibility of stem cells treatment of complex anal fistula in patients with Crohn's disease.
详细描述
Stem cells therapy in the management of soft tissue healing has been shown to be safe and feasible with encouraging short-term results both for crypto glandular and Crohns anal fistula. The long-term results are still insufficient but based on only a few studies conducted with small patient series and various techniques and type of stem cells. In the present study the patient's own adipose tissue derived regenerative cells (ADRCs) will be used. Traditionally the stem cells are injected into the fistula tract; however survival and retaining the stem cells in the fistula tract is problematic. Alternatively, one may apply stem cells enriched fatty tissue around and into the fistula tract. The aim of this project is to develop a method for treatment of patients with Crohns fistula. The results of conventional surgery are disappointing and followed by a high degree of recurrence and complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with Crohn's anal fistulas and> 18 yrs old.
排除标准
- •Signs of suppuration around the fistula
- •Active intestinal Crohn disease not in remission
- •Malignancy within 5 years
- •Previous radiotherapy of the abdomen and pelvis
- •BMI under 18.5
- •Coagulopathy
- •Fistula with side branches
- •Low anal fistula
- •Verified syphilis, HIV, or hepatitis on screening test.
结局指标
主要结局
healing
时间窗: 6 months
closure of the fistula with no secretions
次要结局
- radiological healing(at 6 months)
- recurrence(6 months)
- functional outcome(6 months)
- time to healing(6 months)
- major adverse effects(6 months)
研究者
Karam Matlub Sørensen
afdelingslæge
University of Southern Denmark
