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Allogeneic adipose tissue-derived Mesenchymal stromal cells for the treatment of chronic-active antibody mediated rejection in Kidney transplant recipients (MY-KIDNEY)
EU CTIS ID: 2024-510723-18-00
What this study is testing
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.
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.