A Phase I Study Evaluating Safety and Tolerability of Autologous Bone Marrow-derived Mesenchymal Stromal Cells in Chronic Pancreatitis Patients Who Undergo Total Pancreatectomy and Islet Autotransplantation.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- C-peptide level after mixed meal tolerance test
研究概览
简要总结
The purpose of this study is to show safety and tolerability to our mesenchymal stromal cells (MSCs) product which will be autologous in nature, expanded using a non-xenogeneic, human component expansion media (pooled human platelet lysate) and delivered fresh. Subsequently, the investigators intend to test whether infusion of MSCs immediately after islet autograft can reduce onset of diabetes and improve glycemic control after total pancreatectomy and islet autotransplantation.
详细描述
This is a Phase I study evaluating safety and tolerability of autologous BM-MSCs in chronic pancreatitis patients who undergo total pancreatectomy and islet autotransplantation (TP-IAT). CCT-BMMSC will be infused at one of the following doses: (Tier 1), 20x10^6 cell per patient, (Tier 2), 50x10^6 cell per patient, and (Tier 3), 100x10^6 cell per patient.
Primary objective: To describe and compare the safety and tolerability of infusion of fresh autologous bone marrow-derived Mesenchymal stromal cells after islet transplantation in chronic pancreatitis patients who undergo TP-IAT. The investigators plan to enroll 24 patients for the whole study. The duration of this study is 12 months. The investigators anticipate that this study will be completed within 2 years of commencement.
Secondary objective: Efficacy of infusion of fresh autologous bone marrow-derived Mesenchymal stromal cells together after islet transplantation in chronic pancreatitis patients who undergo TP-IAT as assessed through onset of diabetes, glycemic control, pain relief and quality of life index.
Safety variables: Adverse events (AEs), Laboratory parameters (hematology, biochemistry, urinalysis), Vital signs
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic pancreatitis patients who undergo TP-IAT.
- •>18 years of age.
- •Patients with BMI from 18.5 to
- •Renal function: >90mls/min/1.73m squared
- •Normal INR/PT/PTT values for MUSC clinical laboratory standards
- •Diabetes free before surgery (fasting blood glucose<125mg/dl).
- •No prior pancreatic surgery with the exception of transduodenal sphincteroplasty or Whipple/Beger procedure.
- •Patients with normal liver function as measured by serum levels of aminotransferase including alanine aminotransferase (ALT), and aspartate aminotransferase (AST), and total bilirubin levels.
排除标准
- •Patients whose Hemoglobin, Hematocrit, and Platelet count are above or below normal values for MUSC clinical laboratory standards.
- •Patients who has hematological malignancy.
- •Patients who are under immunosuppression.
- •Patients with marked calcification disease on CT scan.
- •Patients with severe fibrosis and atrophy on pancreas MRI.
结局指标
主要结局
C-peptide level after mixed meal tolerance test
时间窗: 12 months
次要结局
- Liver function, kidney function(12 months after transplant)
- The absence of severe hypoglycemic episodes(12 months after transplant)
研究者
Hongjun Wang
Professor of Surgery
Medical University of South Carolina