Improving KIdney ¬Transplantation with Cellular Therapy Study
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:
- 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).
- Perform testing of TolDC phenotype, tolerogenic capacity and yield.
- 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
- 否
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
Jennifer Li
CPI, Nephrologist and Transplant Physician
Western Sydney Local Health District
