Clinical Study to Evaluate the Efficacy and Safety of Mesenchymal Stromal Cells (Amimestrocel ) i… (NCT06954740) | Clinical Trial Compass
RecruitingPhase 2
Clinical Study to Evaluate the Efficacy and Safety of Mesenchymal Stromal Cells (Amimestrocel ) in Patients With Acute Kidney Injury
China50 participantsStarted 2025-06-10
Plain-language summary
This trial is to evaluate the efficacy and safety of Amimestrocel (human umbilical cord mesenchymal stromal cells) in the treatment of AKI patients.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Aged between 18 and 75 years old; gender is not restricted.
. According to the 2023 KDIGO diagnostic criteria for acute kidney injury (AKI), including those that occur during the course of the disease in various patients with chronic kidney disease (CKD), AKI can be diagnosed if any of the following conditions is met:
. .Ability to give informed consent.
Exclusion criteria
. Post-renal AKI.
. Acute kidney injury caused by glomerular diseases such as rapidly progressive glomerulonephritis, lupus nephritis, anti-neutrophil cytoplasmic antibody-associated nephritis, anti-glomerular basement membrane antibody-mediated nephritis, vasculitis, cryoglobulinemia, thrombotic microangiopathy, etc.
. Hemodynamic instability.
. Severe cardiovascular diseases.
. Severe pulmonary dysfunction.
. A history of intracerebral hemorrhage or cerebral infarction within the past six months.
. Subjects with abnormal laboratory indicators: AST or ALT \> 5 × upper limit of normal value (ULN); total bilirubin \> 3 × ULN; white blood cell count \< 2000/μL (2 × 10⁹/L), hemoglobin \< 6 g/dL (60 g/L), neutrophils \< 1000/μL (1 × 10⁹/L), platelets \< 50000/μL (50 × 10⁹/L).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing a cell therapy called Amimestrocel — a type of mesenchymal stromal cell — which is different from any drug I've heard of before. Can you explain how this treatment is thought to help injured kidneys, and what makes it different from standard care for acute kidney injury?
2Since this is a Phase 2 trial, what do we actually know so far about whether Amimestrocel is safe, and what are the risks I should be aware of that haven't been fully studied yet at this stage?
3The trial is measuring serum creatinine as its main outcome — can you help me understand what that means for my specific situation, and whether a change in creatinine levels would translate into a meaningful difference in how my kidneys function long-term?
4Is there a standard treatment for my acute kidney injury that I should consider first, or is my situation one where you think enrolling in a trial like this might genuinely be worth discussing as an option right now?
5This trial is actively recruiting, so if I were to look into it, what would participation actually involve day-to-day — things like hospital visits, monitoring, or time commitments — and how would that fit with my current care and recovery?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.