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临床试验/NCT06243289
NCT06243289终止不适用

Improving KIdney ¬Transplantation with Cellular Therapy Study

Western Sydney Local Health District1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2023年9月19日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
1
主要终点
Tolerogenic dendritic cells

研究概览

简要总结

The i-KITCaT study aims to harness cellular therapies to favourably alter the immunological response to in AKI in transplantation. Kidney transplantation offers the best survival and quality of life outcomes for patients with end-stage kidney disease but requires life-long immunosuppression. Efforts to increase the donor organ pool means accepting kidneys which have been subjected to medical and surgical factors culminating in acute kidney injury (AKI).

There is no treatment to modify the maladaptive injury process following an AKI insult, and this subjects the new kidney to increased risk of needing dialysis in the first 7 days of transplantation, rejection, and shortened transplant survival.

Tolerogenic dendritic cells (TolDC) are currently used in phase I/II clinical trials and are safe for patients receiving a kidney transplant from the same donor as these cells. These trials focus on transplant tolerance, but we will re-purpose TolDCs to favorably alter the disease course following AKI and limit injury following transplantation.

Furthermore, if the patient's own cells (rather than from a third-party donor) can be used, this avoids supply limitations and potential sensitization risk. We will compare the functional characteristics of TolDC generated from control (healthy) and kidney disease (chronic kidney disease (CKD), dialysis and transplantation).

详细描述

This observational, cohort study will be conducted at Westmead Hospital

  • 3 visits over 24-months per participant.
  • each consenting participant will donate 20 - 50ml of peripheral blood per visit.
  • recruit n = 20 per study group (control, CKD, dialysis, and transplant).

Aims include:

  1. Compare generation of therapeutic grade tolerogenic dendritic cells (TolDC) from peripheral blood mononuclear cells derived from controls (healthy) and patients with kidney disease (CKD, dialysis, or transplantation).
  2. Perform testing of TolDC phenotype, tolerogenic capacity and yield.
  3. Generate hypothesis for different mechanisms of TolDC function not yet described for further characterisation to support future research

Research plan:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • able to consent, able to provide blood sample

排除标准

  • unable to consent, life-expectancy less than 6 months

结局指标

主要结局

Tolerogenic dendritic cells

时间窗: 7 days post ex-vivo culture

Test flow cytometry, cytokine assays and mixed lymphocyte reaction to show tolerogenic potential of ex-vivo tolerogenic dendritic cells derived from peripheral blood monocytes of donors with and without kidney disease

次要结局

  • Transcriptomic differences in tolerogenic dendritic cells derived from healthy and kidney disease donors(12-months from culture/ex-vivo generation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Li

CPI, Nephrologist and Transplant Physician

Western Sydney Local Health District

研究点 (1)

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