Amimestrocel (umbilical cord mesenchymal stromal cells) for acute kidney injury

Clinical Study to Evaluate the Efficacy and Safety of Mesenchymal Stromal Cells (Amimestrocel ) in Patients With Acute Kidney Injury

This trial tests whether Amimestrocel (umbilical cord mesenchymal stromal cells) can help adults aged 18–75 with acute kidney injury recover kidney function while monitoring safety.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chinese PLA General Hospital (other)
• Locations: 6 sites (Beijing, Beijing Municipality and 5 other locations)
• Trial ID: NCT06954740 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional trial gives Amimestrocel (human umbilical cord-derived mesenchymal stromal cells) to adults with acute kidney injury defined by the 2023 KDIGO criteria. Eligible participants are 18–75 years old and must meet KDIGO thresholds for serum creatinine rise or reduced urine output, with baseline creatinine estimated if prior values are unavailable. Participants receive the investigational cell therapy and are followed for safety and kidney outcomes such as changes in serum creatinine, urine output, and need for dialysis. The trial is run at tertiary hospitals in Beijing under the lead of the Chinese PLA General Hospital.

Who should consider this trial

Good fit: Adults aged 18–75 who meet the 2023 KDIGO criteria for acute kidney injury (creatinine increase or decreased urine output) are the intended participants.

Not a fit: Patients younger than 18 or older than 75, those who do not meet KDIGO-defined AKI, or those with contraindications to mesenchymal stromal cell therapy are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, the treatment could speed recovery of kidney function and reduce the need for dialysis in patients with AKI.

How similar studies have performed: Prior preclinical studies and small clinical reports suggest MSCs can protect or repair injured kidneys, but larger randomized trial results are limited and mixed.

Eligibility criteria

Inclusion Criteria:

1. Aged between 18 and 75 years old; gender is not restricted.
2. 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:

   ① The serum creatinine level increases by ≥ 26.5 μmol/L within 48 hours;

   ② The serum creatinine level increases by more than 1.5 times or higher than the baseline value within 7 days;

   ③ The urine output decreases (\< 0.5 mL/kg/h) and persists for more than 6 hours; The baseline value of serum creatinine: The lowest creatinine value obtained in the outpatient department or ward within 3 months, and the longest time limit is the creatinine value within 1 year. If there is no such value, the serum creatinine can be estimated using the MDRD equation under the assumption that the baseline eGFR is 75 ml/min/1.73m².
3. .Ability to give informed consent.

Exclusion Criteria:

1. Post-renal AKI.
2. 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.
3. Hemodynamic instability.
4. Severe cardiovascular diseases.
5. Severe pulmonary dysfunction.
6. A history of intracerebral hemorrhage or cerebral infarction within the past six months.
7. 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).
8. Uncontrollable infection.
9. Patients with active hepatitis B or hepatitis C virus infection, active tuberculosis, severe immunodeficiency diseases, human immunodeficiency virus (HIV) infection, etc.
10. Received systemic immunosuppressants or glucocorticoid treatment for more than one week within 30 days before enrollment.
11. Have received hemodialysis or peritoneal dialysis treatment.
12. Have a history of hematopoietic stem cell transplantation or solid organ transplantation.
13. Patients with a history of malignant tumor within the past 5 years.
14. Life expectancy is less than 1 month.
15. Those with a known history of severe allergy to component blood or blood products, or those with a history of allergy to heterologous proteins.
16. Lactating women, or female patients who have a pregnancy plan or an egg donation plan from the start of the study to the follow-up period, and male patients (or their partners) who have a fertility plan or a sperm donation plan from the start of the study to the follow-up period and are unwilling to take contraceptive measures.
17. Patients who participated in other interventional clinical trials within 1 month before enrollment.

Where this trial is running

Beijing, Beijing Municipality and 5 other locations

• Beijing hospital — Beijing, Beijing Municipality, China (RECRUITING)
• China-Japan Friendship Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Capital Medical University Affiliated Beijing Friendship Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Xuanwu Hospital, Capital Medical University — Beijing, Beijing Municipality, China (RECRUITING)
• Chinese PLA General Hospital — Beijing, Beijing Municipality, China (RECRUITING)
• Beijing Tsinghua Changgung Hospital, Medical Center, Tsinghua University — Beijing, Beijing Municipality, China (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: xiangmei chen

Conditions: Acute Kidney Injury, mesenchymal stromal cells, acute kidney injury