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临床试验/NCT03466515
NCT03466515已完成不适用

Stem Cells Treatment of Complex Crohns Perianal Fistula. A Pilot Clinical Study

University of Southern Denmark2 个研究点 分布在 1 个国家目标入组 13 人开始时间: 2018年6月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Karam Matlub Sørensen

afdelingslæge

University of Southern Denmark

研究点 (2)

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