NCT06568653尚未招募2 期
The Efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes Injection for Treatment of Complex Anal Fistula in Colorectal Surgery Department of Imam Khomeini Hospital Complex: A Non-randomized Clinical Trial.
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- The number of fistula openings (orifices) will be assessed before and after our intervention.
研究概览
简要总结
The goal of this clinical trial is to learn if human placenta mesenchymal stem cells (MSC)-derived exosomes work to treat complex perianal fistula in adults without Crohn's disease. The safety of this treatment will also be learned. The main questions it aims to answer are:
- Does treatment with MSC-derived exosomes lower the number of fistula recurrences in participants?
- Is treatment with MSC-derived exosomes safe? We will compare treatment with MSC-derived exosomes to the routine treatment which is fistulotomy (surgery to close the fistula) alone to see if MSC-derived exosomes work better to treat complex fistula.
Participants will:
- Undergo fistulotomy plus MSC-derived exosome injections or fistulotomy alone.
- Visit the clinic the week after surgery and then every 4 weeks for checkups and tests
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •participants with complex perianal fistula
- •provided written informed consent
排除标准
- •participants with any inflammatory bowel diseases
- •pregnant or lactating participants
- •participants with contraindications for surgery
- •participants with hepatitis
- •participants with uncontrolled diabetes
- •participants with alcohol or substance abuse
结局指标
主要结局
The number of fistula openings (orifices) will be assessed before and after our intervention.
时间窗: 3 months
clinical improvement
次要结局
- QoL questionnaire(3 months)
研究者
相似试验
招募中
1 期
Safety and Efficacy of Injection of Human Placenta Mesenchymal Stem Cells Derived Exosomes for Treatment of Complex Anal FistulaFistula PerianalNCT05402748Tehran University of Medical Sciences80
Unknown
1 期
Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Ankylosing Spondylitis (AS)Ankylosing SpondylitisNCT01420432Shandong University10
Unknown
2 期
Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Severe Aplastic AnemiaAplastic AnemiaNCT01182662Shandong University30
Unknown
2 期
Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Myelodysplastic SyndromesMyelodysplastic SyndromesNCT01129739Shandong University30
Unknown
1 期
Safety of Injection of Placental Mesenchymal Stem Cell Derived Exosomes for Treatment of Resistant Perianal Fistula in Crohn's PatientsPerianal Fistula in Patients With Crohn's DiseaseNCT05499156Tehran University of Medical Sciences80