Actively Recruiting
Clinical Study to Evaluate the Efficacy and Safety of Mesenchymal Stromal Cells (Amimestrocel ) in Patients With Acute Kidney Injury
Led by Chinese PLA General Hospital · Updated on 2025-09-08
50
Participants Needed
6
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is to evaluate the efficacy and safety of Amimestrocel (human umbilical cord mesenchymal stromal cells) in the treatment of AKI patients.
CONDITIONS
Official Title
Clinical Study to Evaluate the Efficacy and Safety of Mesenchymal Stromal Cells (Amimestrocel ) in Patients With Acute Kidney Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 18 and 75 years old; gender is not restricted.
- Diagnosed with acute kidney injury (AKI) based on 2023 KDIGO criteria, including cases during chronic kidney disease.
- Able to provide informed consent.
You will not qualify if you...
- Post-renal acute kidney injury.
- AKI caused by specific glomerular diseases such as rapidly progressive glomerulonephritis, lupus nephritis, and others.
- Hemodynamic instability.
- Severe cardiovascular diseases.
- Severe pulmonary dysfunction.
- History of intracerebral hemorrhage or cerebral infarction within the past six months.
- Abnormal lab results including very high liver enzymes, low white blood cells, hemoglobin, neutrophils, or platelets.
- Uncontrollable infection.
- Active hepatitis B or C, active tuberculosis, severe immunodeficiency, or HIV infection.
- Use of systemic immunosuppressants or glucocorticoids for more than one week within 30 days before enrollment.
- Prior hemodialysis or peritoneal dialysis treatment.
- History of hematopoietic stem cell or solid organ transplantation.
- History of malignant tumor within the past 5 years.
- Life expectancy less than 1 month.
- Known severe allergies to blood products or heterologous proteins.
- Lactating women or those planning pregnancy, egg donation, fertility, or sperm donation during study and follow-up who do not use contraception.
- Participation in other interventional clinical trials within 1 month before enrollment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Beijing hospital
Beijing, Beijing Municipality, China, 100010
Actively Recruiting
2
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
3
Capital Medical University Affiliated Beijing Friendship Hospital
Beijing, Beijing Municipality, China, 100050
Actively Recruiting
4
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100053
Actively Recruiting
5
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
Actively Recruiting
6
Beijing Tsinghua Changgung Hospital, Medical Center, Tsinghua University
Beijing, Beijing Municipality, China
Not Yet Recruiting
Research Team
X
xiangmei chen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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