Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Active Ulcerative Colitis.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Safety will be determined by the assessment of major adverse events.
研究概览
简要总结
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with active ulcerative colitis，randomized, single blind, controlled prospective study.
详细描述
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with active ulcerative colitis，randomized, single blind, controlled prospective study.
Thirty patients will be selected and randomized into two groups: the first group of 15 patients will receive a sole injection of UC-MSC and the remaining 15 patients will comprise the control group.
Every patient will maintain their standard treatment of active ulcerative colitis, with maximum tolerated dosage without side effects.
The day of infusion will be considered day zero. From that moment, followup will be divided into 0-1 week, 1 week-2 week,2 week-3 week, 3 week-1 month, and 3 month-6 months.
Clinical results will be analyzed after completion of 6 months of followup.
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
- Single (Participant)
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
- •The diagnosis of active UC must have been confirmed by endoscopic and histological evidence.
- •With mild and moderate disease.
- •Men and women 18-65 years of age.
- •Signed informed consent
- •Capable of good communication with researchers and follow the entire test requirements
排除标准
- •Patient with associated diseases such as diabetes mellitus, hypertension, dyslipidemia, atherosclerosis and malabsorption syndrome.
- •With autoimmune diseases (lupus, HIV, cancer and hepatitis), colitis (infectious, post-radiation, post-drug, indeterminate) and Crohn's Disease.
- •Abnormal hepatic or renal function
- •Prior history of malignancy
- •Pregnant or unwilling to practice contraceptive therapy or breast feeding females
结局指标
主要结局
Safety will be determined by the assessment of major adverse events.
时间窗: Within the six months after intravenous infusion
Safety will be determined by the assessment of major adverse events defined as fever, allergy or any other intravenous infusion adverse events.
次要结局
- Clinical response (CDAI points)(Post first cell transplantation: 3 weeks and months 1,3 and 6)
- Endoscopic improvement is assessed by UCEIS.(Post first cell transplantation 6 months)
- Level of C-reactive protein(Post first cell transplantation: 3 weeks and months 1,3 and 6)