NCT06649864尚未招募1 期
A Phase I Study of Autologous Adipose-derived Mesenchymal Stromal Cells in Preventing Biliary Complications After Living Donor Liver Transplant
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Side effects
研究概览
简要总结
The purpose of this study is to assess the safety of autologous Adipose-Derived Mesenchymal Stem Cell for use in End-Stage Liver Disease patients undergoing the creation of a duct-to-duct anastomosis during Living Donor Liver Transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Listed for liver transplantation
- •Non-pediatric patients with a planned LDLT
- •Ability to communicate with investigative staff
- •Competence to give written informed consent
- •Ability to comply with the entire study procedure
- •All sexes and genders will be eligible for the study
排除标准
- •Planned deceased donor liver transplantation
- •Uncontrolled / unresolved local or systemic infection
- •Body mass index > 40
- •Planned pancreaticoduodenectomy or sleeve gastrectomy
- •Anticipation of 3 biliary anastomoses (we will include those anticipated to have 1 or 2 biliary anastomoses as detailed below)
- •Pregnancy or breastfeeding
- •Non-liver cancers (we will include certain patients with primary liver cancer as detailed below)
- •Treatment with any investigational drug / device within 60 days prior to study entry
- •Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of AMSCs
- •Patients who are employees or relatives of the investigator
研究组 & 干预措施
Liver Transplant
Experimental
Subjects with liver disease with planned living donor liver transplantation
干预措施: Autologous adipose derived mesenchymal stromal cells (AMSC) (Drug)
结局指标
主要结局
Side effects
时间窗: 24 months
Number of subjects to experience systemic symptoms, irritation, inflammation, infections or biliary obstructions
次要结局
- Biliary complications(24 months)
研究者
Julie K. Heimbach
Principal Investigator
Mayo Clinic
研究点 (2)
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