Clinical Study to Evaluate the Efficacy and Safety of Mesenchymal Stromal Cells (Amimestrocel ) in Patients With Acute Kidney Injury (MSC-AKI-001)

September 5, 2025 updated by: Chen Xiangmei, Chinese PLA General Hospital
This trial is to evaluate the efficacy and safety of Amimestrocel (human umbilical cord mesenchymal stromal cells) in the treatment of AKI patients.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100053
        • Recruiting
        • Xuanwu Hospital, Capital Medical University
        • Contact:
        • Principal Investigator:
          • aihua Zhang
        • Sub-Investigator:
          • xingtong Dong
      • Beijing, Beijing Municipality, China, 100029
        • Recruiting
        • China-Japan Friendship Hospital
        • Contact:
        • Principal Investigator:
          • wenge Li
        • Sub-Investigator:
          • dai Shang
      • Beijing, Beijing Municipality, China, 100010
        • Recruiting
        • Beijing Hospital
        • Principal Investigator:
          • yonghui Mao
        • Contact:
        • Sub-Investigator:
          • ban Zhao
      • Beijing, Beijing Municipality, China, 100050
        • Recruiting
        • Capital Medical University Affiliated Beijing Friendship Hospital
        • Contact:
        • Principal Investigator:
          • hongdong Huang
        • Sub-Investigator:
          • dai Deng
      • Beijing, Beijing Municipality, China, 100853
        • Recruiting
        • Chinese PLA General Hospital
        • Contact:
      • Beijing, Beijing Municipality, China
        • Not yet recruiting
        • Beijing Tsinghua Changgung Hospital, Medical Center, Tsinghua University
        • Contact:
        • Principal Investigator:
          • Yuehong Li
        • Sub-Investigator:
          • minxia Li

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Amimestrocel
In experimental group,patients receive standard treatment and Amimestrocel is administered via Intravenous infusion on day 1, 4, 8,15.
Drug: Amimestrocel
Amimestrocel will be administered at a target dose of 1×10E6 MSCs/kg body weight on day 1, 4, 8, 15.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum creatinine
Time Frame: Change from baseline at 28 days
Change from baseline at 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
serum creatinine
Time Frame: Change from baseline at 8,15,21 days, and 2, 3 months.
Change from baseline at 8,15,21 days, and 2, 3 months.
Stage of AKI
Time Frame: Change from baseline at 8, 15, 21, 28 days, and 2, 3 months.
Evaluate the staging of Acute Kidney Injury (AKI) according to KDIGO guidelines.
Change from baseline at 8, 15, 21, 28 days, and 2, 3 months.
proportion of study participants with Renal Replacement Therapy(RRT)
Time Frame: proportion of study participants with RRT at 4, 8, 12 weeks and 12, 24 months
proportion of study participants with RRT at 4, 8, 12 weeks and 12, 24 months
APACHE II or APACHE III
Time Frame: Change from baseline at 8, 15, 21, 28 days, 2, 3,12, 24 months
Change from baseline at 8, 15, 21, 28 days, 2, 3,12, 24 months
SOFA
Time Frame: Change from baseline at 8, 15, 21, 28 days, 2, 3,12, 24 months
Sequential Organ Failure Assessment Score
Change from baseline at 8, 15, 21, 28 days, 2, 3,12, 24 months
all-cause mortality ratio
Time Frame: All-cause mortality ratio at 28 days
All-cause mortality ratio at 28 days
Mechanism exploration
Time Frame: Change from baseline at 8, 15, 28 days, 3 months.
Explore the mechanism through blood tests（Serum/plasma concentrations (pg/ml) of biomarkers of inflammation. Proportion/total number of circulating T cells, B cells, NK cells, etc ） and urine tests(mRNA, miRNA, etc)
Change from baseline at 8, 15, 28 days, 3 months.
Adverse Event and Serious Adverse Event
Time Frame: Within 12 weeks after received Amimestrocel
Within 12 weeks after received Amimestrocel
secondary malignant disease
Time Frame: Within 24 months after received Amimestrocel
Number of Participants with secondary malignant disease
Within 24 months after received Amimestrocel

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2025

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

May 15, 2028

Study Registration Dates

First Submitted

April 24, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 2, 2025

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

September 5, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S2025-167 (Other Identifier: Ethics Committee of Chinese PLA General Hospital)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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