Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06954740

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

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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

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