Acute Kidney InjuryPhase 2MSC-AKI-001NCT06954740
Clinical Study to Evaluate the Efficacy and Safety of Mesenchymal Stromal Cells (Amimestrocel ) in Patients With Acute Kidney Injury
A Phase 2 study testing Amimestrocel in people with Acute Kidney Injury, run by Chinese PLA General Hospital at 6 sites in China.
Trial summary
This trial is to evaluate the efficacy and safety of Amimestrocel (human umbilical cord mesenchymal stromal cells) in the treatment of AKI patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- Amimestrocel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesChina
- Study dates
- 10 Jun 2025to 15 May 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 17Show fewer
- 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.
- 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.
- Patients who participated in other interventional clinical trials within 1 month before enrollment.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Beijing hospital
Beijing, Beijing Municipality, 100010
Ban Zhao, 86 13910425475, zbyule@139.com
yonghui Mao
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 100029
shunlai Shang, 86 17732215650, 18810568600@163.com
wenge Li
- Recruiting
Capital Medical University Affiliated Beijing Friendship Hospital
Beijing, Beijing Municipality, 100050
dai Deng, 86 01063138772, dazziling@163.com
hongdong Huang
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 100053
xingtong Dong, 86 156 9995 9558, zhangaihua0982@sina.com
aihua Zhang
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
ping li, +86 010 66935462, liping.8@163.com
- Not yet recruiting
Beijing Tsinghua Changgung Hospital, Medical Center, Tsinghua University
Beijing, Beijing Municipality
minxia Li, 86 13810136821, lyha01051@btch.edu.cn
yuehong Li
About this study
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
- Being tested
- Amimestrocel
- Keywords
- mesenchymal stromal cells (MSCs), acute kidney injury(AKI)
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmimestrocelDrug
Amimestrocel will be administered at a target dose of 1×10^6 MSCs/kg body weight on day 1, 4, 8, 15.
| Study group | Role | What they receive |
|---|---|---|
| Amimestrocel | Experimental | In experimental group,patients receive standard treatment and Amimestrocel is administered via Intravenous infusion on day 1, 4, 8,15. Receives: Drug: Amimestrocel |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum creatinine
Measured: Change from baseline at 28 days
Secondary outcomes (9)
serum creatinine
Measured: Change from baseline at 8,15,21 days, and 2, 3 months.
Stage of AKI
Evaluate the staging of Acute Kidney Injury (AKI) according to KDIGO guidelines.
Measured: Change from baseline at 8, 15, 21, 28 days, and 2, 3 months.
proportion of study participants with Renal Replacement Therapy(RRT)
Measured: proportion of study participants with RRT at 4, 8, 12 weeks and 12, 24 months
APACHE II or APACHE III
Measured: Change from baseline at 8, 15, 21, 28 days, 2, 3,12, 24 months
SOFA
Sequential Organ Failure Assessment Score
Measured: Change from baseline at 8, 15, 21, 28 days, 2, 3,12, 24 months
all-cause mortality ratio
Measured: All-cause mortality ratio at 28 days
Mechanism exploration
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)
Measured: Change from baseline at 8, 15, 28 days, 3 months.
Adverse Event and Serious Adverse Event
Measured: Within 12 weeks after received Amimestrocel
secondary malignant disease
Number of Participants with secondary malignant disease
Measured: Within 24 months after received Amimestrocel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start10 Jun 2025
- Primary completion15 Aug 2026 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Xiangmei, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954740
- Sponsor's protocol ID
- S2025-167
- Other IDs
- S2025-167
- Acronym
- MSC-AKI-001
- Status last verified
- Jul 2026
- First submitted
- 24 Apr 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Efficacy and Safety of Mesenchymal Stromal Cells (Amimestrocel ) in Patients With Acute Kidney Injury
- ClinicalTrials.gov ID
- NCT06954740
- Acronym / sponsor ID
- MSC-AKI-001 / S2025-167
- Conditions
- Acute Kidney Injury
- Keywords
- mesenchymal stromal cells (MSCs), acute kidney injury(AKI)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 10 Jun 2025 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 2 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is to evaluate the efficacy and safety of Amimestrocel (human umbilical cord mesenchymal stromal cells) in the treatment of AKI patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amimestrocel | Experimental | Drug: AmimestrocelIn experimental group,patients receive standard treatment and Amimestrocel is administered via Intravenous infusion on day 1, 4, 8,15. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmimestrocelAmimestrocel will be administered at a target dose of 1×10^6 MSCs/kg body weight on day 1, 4, 8, 15. | Drug | Amimestrocel |
Primary outcome
serum creatinine
Time frame: Change from baseline at 28 days
9 secondary outcomes
serum creatinine
Time frame: 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.
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
APACHE II or APACHE III
Time frame: 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
all-cause mortality ratio
Time frame: All-cause mortality ratio at 28 days
Mechanism exploration
Time frame: Change from baseline at 8, 15, 28 days, 3 months.
Adverse Event and Serious Adverse Event
Time frame: Within 12 weeks after received Amimestrocel
secondary malignant disease
Time frame: Within 24 months after received Amimestrocel
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
Related trials for Acute Kidney Injury
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Early Biomarker Kidney Injury Assessment After Acumen Directed Fluid Management in Cardiac Surgery
Renal Injury, Acute Kidney Injury
Recruiting
Acute Kidney Injury and Ultra-endurance Running
AKI (Acute Kidney Injury) Due to Trauma
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Not yet recruitingObservational study
Diastolic Shock Index for Predicting Hemodynamic Instability During Continuous Renal Replacement Therapy
Acute Kidney Injury, Hypotension (MeSH: D007022)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amimestrocel in people with Acute Kidney Injury, run by Chinese PLA General Hospital at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xiangmei chen (01066935462, liping.8@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum creatinine (time frame: Change from baseline at 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.