A Phase I/II Randomized, Controlled, Clinical Trial for Assessment of the Safety and Efficacy of Allogeneic Adipose Mesenchymal Stem Cells in Moderate to Severe Ulcerative Colitis Patients
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change From Baseline in Endoscopic Score (as Measured by Ulcerative Colitis Endoscopic Index of Severity)
研究概览
简要总结
Ulcerative colitis is a form of inflammatory bowel disease characterized by diffuse inflammation of the colonic mucosa. It affects the rectum and extends proximally along a variable length of the colon. Ulcerative colitis is a chronic condition with a relapsing remitting course. Mesenchymal stem cells (MSCs) are a subset of adult stem cells residing in many tissues, including bone marrow (BM), adipose tissue, umbilical cord blood. Recent experimental findings have shown the ability of MSCs to home to damaged tissues and to produce paracrine factors with anti-inflammatory properties, potentially resulting in reduction of inflammation and functional recovery of the damaged tissues. The purpose of our study is to evaluate safety and efficacy of the intracolonic injection by using a colonoscope of allogeneic adipose MSCs in patients with moderate active ulcerative colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18-65 years old
- •Diagnosis of ulcerative colitis diagnosed at least 6 months earlier
- •Moderate or severe activity defined by a Mayo score
- •No serious infection, chronic diseases, diabetes and tuberculosis
- •Unefficient by using 5-ASA, glucocorticoid or azathioprine
- •Written informed consents were obtained from all subjects
- •Capable of good communication with researchers and follow the entire test requirements
- •Negative pregnancy test for women of childbearing potential (from menarche to menopause)
排除标准
- •Pregnant or breastfeeding women or cognitively impaired adults
- •History of malignant disease
- •Infectious colitis
- •Patients with known allergies to culture medium
- •Patients having participated in clinical trials with any investigational drug within 1 month prior to enrolment in this study
- •Patients with suspicion of Crohn's enterocolitis, indeterminate colitis, ischaemic colitis, radiation colitis, diverticular disease associated colitis, or microscopic colitis
- •Patients with previous colectomy
- •Positive to one or more of the infectious disease panel
- •Treatment with surgery or biological treatment (infliximab or adamizumab) or Cyclosporine or tacrolimus or mycophenolate in the 8 weeks prior to inclusion in the study
- •Presence of severe concomitant diseases
- •Patients with clostridium difficult or cytomegalovirus infection
结局指标
主要结局
Change From Baseline in Endoscopic Score (as Measured by Ulcerative Colitis Endoscopic Index of Severity)
时间窗: Baseline, 8 weeks
Ulcerative Colitis Endoscopic Index of Severity (UCEIS) is defined as Ulcerative Colitis Endoscopic Index of Severity, with higher scores indicating more severe disease
次要结局
- Change from Baseline in clinical response (CDAI points)(Baseline, 8 weeks)
- To evaluate the quality of life index, Short Inflammatory Bowel Disease Questionnaire (SIBDQ)(Baseline, 8 weeks)
- Immune response in ulcerative colitis.(Baseline, 1, 4, 8 weeks)
- Histologic Evaluation of Ulcerative Colitis(Baseline, 8 weeks)
- Incidence of Treatment Adverse.(Baseline, 1, 4, 8 weeks)
研究者
peng yan
Chief of gastroenterology
Liaocheng People's Hospital