Autologous Mesenchymal Stromal Cells and Islet Co-transplantation to Enhance Islet Survival and Function in Chronic Pancreatitis Patients Undergo Total Pancreatectomy and Islet Autotransplantation
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in Islet Cell Function
研究概览
简要总结
This is a clinical trial for chronic pancreatitis (CP) patients undergoing total pancreatectomy with islet autotransplantation (TP-IAT). Participants will be randomized to either bone marrow-derived mesenchymal stem cells (MSCs) or control with the standard of care. Participants will be followed for one-year post-transplant.
详细描述
This will be a randomized, controlled clinical trial for CP patients scheduled to undergo a TP-IAT surgery. Those who are consented will be randomized into one of three groups. One group will receive islet transplantation alone, a placebo. The other two groups will receive islets plus autologous bone marrow-MSCs at two different doses (20x10^6/patient, or 50x10^6/patient). The TP-IAT procedure will remain as routinely performed. Patients will be followed for12 months post-transplantation, having 3 follow-up visits scheduled on days 90, 180, and 365 after the transplant. The primary endpoint will be a change in islet function from baseline to 12 months post-transplantation as measured by the C-peptide area under the curve following a mixed meal tolerance test. Potential effects of MSCs on glycemic control, pain relief, quality of life, and adverse events will be evaluated at each follow-up visit.
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 (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of CP and scheduled for TP-IAT;
- •≥18 years old;
- •Diabetes with HbA1c <12%.
排除标准
- •Patients who are under immunosuppression;
- •Pregnant and breastfeeding women.
- •Patients who have liver damage based on ALT, AST, and total bilirubin levels (>3 times normal levels);
研究组 & 干预措施
Placebo
One time infusion of islets only.
干预措施: Placebo (Other)
BM-MSCs at 20x10^6
One time infusion of islets plus BM-MSCs at 20x10^6/patient, n=14
干预措施: Bone marrow-derived mesenchymal stem cells (Biological)
BM-MSCs at 50x10^6
One time infusion of islets plus BM-MSCs at 50x10^6/patient, n=14
干预措施: Bone marrow-derived mesenchymal stem cells (Biological)
结局指标
主要结局
Change in Islet Cell Function
时间窗: 1 year
The primary endpoint will be change in islet function between baseline and 12 months as measured by area under the curve of C-peptide levels during a mixed meal tolerance test (MMTT) adjusted by islet equivalent number (IEQ) transplanted.
次要结局
- Change in HbA1C levels from baseline to 12 months.(1 year)
- Proportion of insulin-independent patients following IAT(1 year)
- Average daily insulin requirement(1 year)
- Beta cell function as assessed by beta-score(1 year)
研究者
Hongjun Wang
Professor, Scientific Director, Center for Cellular Therapy
Medical University of South Carolina