Safety and Efficacy of Injection of Human Placenta Mesenchymal Stem Cells Derived Exosomes for Treatment of Complex Anal Fistula
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- clinical Efficacy of injected exosomes
研究概览
简要总结
Study aim:
Safety of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of complex Anal Fistula 2.Efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of refractory Anal Fistula 3.Fistula changes in MRI studies, 12 weeks after treatment 4.Evaluation of quality of life in perianal fistula patient's questionnaire score before and 12 weeks after treatment
Participants/Inclusion and exclusion criteria:
inclusion Criteria : 1.Age between 18-70 years old 2.Occurrence of complex perianal fistula 3.Informed consent Exclusion Criteria: 1.Active inflammatory bowel disease 2.Synchronous perianal abscess 3.Alcohol,narcotic and stimulant consumption 4.Having active Hepatitis B,C,HIV or TB 5.Peregnancy and lactation 6.Uncontrolled diabetes mellitus 7.Evidence of surgical contraindication 8.Psychological disorders and noncooperative patient
Intervention groups:
Human Placenta Mesenchymal Stem Cells Derived Exosomes injected in fistula tract of patients with complex perianal Fistula in 3 weekly episodes and it's safety and efficacy was evaluated.
Design:
this study includes two separate groups of cases and controls each consisting of 40 participants randomly allocated for the phase 2 of clinical trial.
Settings and conduct:
Patients with complex perianal fistula referred to Imam Khomeini hospital, will be included in the study if they contain inclusion criteria. The fistula was evaluated by clinical examination and MRI and patients fill the quality of life questionnaire. Exosome injections are performed weekly for consecutive three weeks. Patients will reexamined and fill the questionnaire and MRI will done 12 weeks later. Recent findings will compare with the initial data. During this period, patients are examine for complications.
Main outcome variables:
Discharge amount; External orifice re-epithelialization ; Inflammation, discharge and abscess larger than 2 cm in MR imaging; Quality of life questionnaire score, Inflammatory markers such as CRP, IL-6, TNF-a, calprotectin
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, 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
- •Age between 18-70 years old
- •Occurrence of complex perianal fistula
- •Informed consent
排除标准
- •Active inflammatory bowel disease
- •Synchronous perianal abscess
- •Alcohol,narcotic and stimulant consumption
- •Having active Hepatitis B,C,HIV or TB
- •Peregnancy and lactation
- •Uncontrolled diabetes mellitus
- •Evidence of surgical contraindication
- •Psychological disorders and noncooperative patient
结局指标
主要结局
clinical Efficacy of injected exosomes
时间窗: 3 months
assessing the clinical response to therapy which might demonstrate itself as closure of refractory fistulas
inflammatory markers
时间窗: 3 months
assessing inflammatory markers through laboratory workup including CRP, IL-6, TNF-a, calprotectin.
Safety of injected exosomes
时间窗: 3 months
assessing the adverse outcomes after injection such as acute allergic reactions
次要结局
未报告次要终点
研究者
Ahmadi tafti
assistant professor
Tehran University of Medical Sciences