2024-510723-18-00招募中2 期
Allogeneic adipose tissue-derived Mesenchymal stromal cells for the treatment of chronic-active antibody mediated rejection in Kidney transplant recipients
Region Midtjylland1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年2月1日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- 1. Feasibility: number of participants treated with MSC infusion 2. Safety: number of participants without infusional toxicity 3. Clinical: number of participants without graftloss/death/nephrectomy
研究概览
简要总结
The main objective of this trial is to assess safety, feasibility, immunomodulatory and kidney protective effects of intravenous allogeneic MSC therapy in renal transplant recipients with c-aABMR.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •A. Biopsy proven diagnosis of ca-ABMR according to Banff 2017 with following 3 criteria: 1) Morphologic evidence of chronic tissue injury 2) Current/recent antibody interaction with vascular endothelium 3) Serologic evidence of circulating DSA to HLA. B. Age between 18 and 75 years of age. C. Renal transplant recipient first or repeat at least 6 months prior to screening. D. eGFR > 20 ml/min. E. Written, informed consent prior to study inclusion. F. If female and child-bearing potential, subject must be non-pregnant, non-breastfeeding and use adequate contraception.
排除标准
- •a. Multiorgan transplant recipient except for simultaneous kidney-pancreas or previous multiple renal transplants or cell transplants (islet or bone marrow). b. Biopsy proven acute rejection (according to the Banff criteria) in the 4 weeks prior to inclusion. c. Except for steroids, other treatments for ABMR or TCMR are not allowed within 3 months prior to the start of screening. d. On dialysis or expected to commence on dialysis within 3 months of inclusion. e. Evidence of active bacterial or viral infection, (except for an uncomplicated urinary tract infection) (e.g., CMV, Pneumocystis carinii (PCP), HIV, hepatitis B/C, aspergillosis, histoplasmosis, or mycobacteria). f. A psychiatric, addictive or any disorder that compromises ability to give truly informed consent for participation in this study. g. Use of any current investigational drug. h. Malignancy (including lymphoproliferative disease) within the past 2 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence). i. Unwilling or unable to adhere to study requirements and procedures
研究组 & 干预措施
MSC, adipose tissue
Test
干预措施: MSC, adipose tissue (Drug)
结局指标
主要结局
1. Feasibility: number of participants treated with MSC infusion 2. Safety: number of participants without infusional toxicity 3. Clinical: number of participants without graftloss/death/nephrectomy
1. Feasibility: number of participants treated with MSC infusion 2. Safety: number of participants without infusional toxicity 3. Clinical: number of participants without graftloss/death/nephrectomy
次要结局
- 1. Kidney function assessment: change in eGFR from before MSC infusion to after. 2. Chronic kidney rejection/damage assessment: change in kidney biopsy/histology, imaging and urinary findings from before MSC infusion to after. 3. Adverse events assessment: number of grade 3 or higher AEs attributable to MSC infusion 4. Anti-donor immune response assessments: changes in DSAs, immune cells and inflammation markers from before MSC infusion to after. 5.Opportunistic infection assessment: changes in
研究者
Lara Aygen Øzbay
Scientific
Region Midtjylland
研究点 (1)
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