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

NCT06954740 | Recruiting Phase 2

• 1 other identifier: S2025-167
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

Brief Summary

This trial is to evaluate the efficacy and safety of Amimestrocel (human umbilical cord mesenchymal stromal cells) in the treatment of AKI patients.

Conditions

Acute Kidney Injury

Keywords

mesenchymal stromal cells (MSCs); acute kidney injury(AKI)

Outcome Measures

Primary Outcomes (1)

• serum creatinine

  Change from baseline at 28 days

Secondary Outcomes (9)

• serum creatinine

  Change from baseline at 8,15,21 days, and 2, 3 months.

• Stage of AKI

  Change from baseline at 8, 15, 21, 28 days, and 2, 3 months.

• proportion of study participants with Renal Replacement Therapy(RRT)

  proportion of study participants with RRT at 4, 8, 12 weeks and 12, 24 months

• APACHE II or APACHE III

  Change from baseline at 8, 15, 21, 28 days, 2, 3,12, 24 months

• SOFA

  Change from baseline at 8, 15, 21, 28 days, 2, 3,12, 24 months

Study Arms (1)

Amimestrocel

EXPERIMENTAL

In experimental group,patients receive standard treatment and Amimestrocel is administered via Intravenous infusion on day 1, 4, 8,15.

Drug: Amimestrocel

Interventions

Amimestrocel DRUG

Amimestrocel will be administered at a target dose of 1×10E6 MSCs/kg body weight on day 1, 4, 8, 15.

Amimestrocel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• Ability to give informed consent.

You may not qualify if:

• 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).
• Uncontrollable infection.
• Patients with active hepatitis B or hepatitis C virus infection, active tuberculosis, severe immunodeficiency diseases, human immunodeficiency virus (HIV) infection, etc.
• Received systemic immunosuppressants or glucocorticoid treatment for more than one week within 30 days before enrollment.
• Have received hemodialysis or peritoneal dialysis treatment.
• Have a history of hematopoietic stem cell transplantation or solid organ transplantation.
• Patients with a history of malignant tumor within the past 5 years.
• Life expectancy is less than 1 month.
• Those with a known history of severe allergy to component blood or blood products, or those with a history of allergy to heterologous proteins.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (6)

Beijing hospital

Beijing, Beijing Municipality, 100010, China

RECRUITING

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Capital Medical University Affiliated Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

RECRUITING

Xuanwu Hospital, Capital Medical University

Beijing, Beijing Municipality, 100053, China

RECRUITING

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Beijing Tsinghua Changgung Hospital, Medical Center, Tsinghua University

Beijing, Beijing Municipality, China

NOT YET RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

xiangmei chen

CONTACT

01066935462; liping.8@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 2, 2025
• Study Start: June 10, 2025
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2028
• Last Updated: September 8, 2025

Record last verified: 2025-09

Locations

CN (6)