Feasibility and Safety of Allogeneic Adipose Mesenchymal Stem Cells (aMSCs) Delivery Into Kidney Allografts Procured From Deceased Donors With High Kidney Donor Profile Index (KDPI)
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 主要终点
- Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this research is to test an investigational drug called Adipose Mesenchymal Stem Cells (aMSCs) for the treatment of ischemia re-perfusion injury (IRI) in patients that have had a kidney transplant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Male or female kidney transplant candidates age 18 and above.
- •Patient is receiving kidney allograft from deceased donor with KDPI>85%.
- •Ability of subject to give appropriate consent.
- •Females of childbearing potential with agreement to use birth control for six months post-transplant.
- •Approved by the Mayo Clinic Transplant Selection Committee.
- •Signed Authorization for Donation of Anatomical Gifts on file.
排除标准
- •Positive pregnancy test at the time of the kidney offer is called for the potential recipient.
- •Kidney transplant potential recipients with active malignancy (except none melanoma skin malignancies).
- •Patients with previous history of solid organ transplant (Heart, Lung, Intestine, Kidney and/or Pancreas).
- •Patients with previous history of bone marrow transplant.
研究组 & 干预措施
Intra parenchymal injection
5 subjects will receive AMSCs via direct injection into the kidney parenchyma only
干预措施: Allogeneic adipose derived mesenchymal stem cells (Drug)
Intra-arterial infusion
5 subjects will receive AMSCs via intra-arterial infusion only
干预措施: Allogeneic adipose derived mesenchymal stem cells (Drug)
Intra parenchymal injection & Intra-arterial infusion
5 subjects will receive AMSCs via direct injection into the kidney parenchyma and intra-arterial infusion
干预措施: Allogeneic adipose derived mesenchymal stem cells (Drug)
结局指标
主要结局
Serious Adverse Events (SAEs)
时间窗: 1 year
Number of serious adverse events reported. SAEs will include delayed graft function (30 days post-transplant), difficult to control bleeding (intraoperative), sub-scapular kidney hematoma or arteriovenous fistula formation (24 hours postop), and development of stroke, myocardial infarction, or pulmonary embolism (1 year post-transplant).
次要结局
未报告次要终点
研究者
Tambi Jarmi
Principal Investigator
Mayo Clinic