Diabetic Kidney Disease (DKD)Phase 2MSC-DKD-001NCT06969807
Safety and Efficacy of Mesenchymal Stromal Cells (Amimestrocel ) in Diabetic Kidney Disease
A Phase 2 study testing Amimestrocel in people with Diabetic Kidney Disease (DKD), run by Chinese PLA General Hospital at 6 sites in China.
Trial summary
This trial is to evaluate the efficacy and safety of umbilical cord-derived mesenchymal stromal cells (Amimestrocel ) in study subjects with progressive diabetic kidney disease (DKD), to investigate whether Amimestrocel can improve renal function or proteinuria of DKD patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Kidney Disease (DKD)
- 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
- 120 participants
- Where
- 6 sitesChina
- Study dates
- 9 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women who are ≥18 and ≤ 80 years old.
- Diagnosed with type 2 diabetes mellitus.
- Diagnosed with diabetic kidney disease based on renal pathology within the past 10 years.
- The 24-hour urine protein quantification is continuously ≥ 3.5 g, or the urine albumin-to-creatinine ratio (UACR) > 1000 mg/g.
- The estimated glomerular filtration rate (eGFR) ≥ 15 ml/min/1.73m² (calculated according to the CKD-EPI formula).
- The blood pressure can be controlled at BP ≤ 160/100 mmHg.
- Glycated hemoglobin (HbA1c) < 9%.
- Willing and able to provide written informed consent.
Who cannot join
- Patients with kidney diseases not caused by diabetes mellitus.
- Patients who have received treatment with systemic immunosuppressants (such as cyclosporine A, tacrolimus, mycophenolate mofetil, etc.) within 30 days before enrollment and the duration of treatment exceeds one week.
- Severe cardiovascular diseases, such as congenital heart diseases, atrial fibrillation, NYHA class Ⅲ-IV, unstable angina pectoris, etc.
- A history of cerebral hemorrhage or cerebral infarction within the past six months (except for those with a history of lacunar cerebral infarction without residual limb movement disorders, cognitive and language function disorders).
- Patients with severe hyperlipidemia: (serum triglyceride ≥ 6.2 mmol/L, serum low-density lipoprotein cholesterol ≥ 4.1 mmol/L).
- Hyperkalemia that cannot be controlled through diet or potassium-lowering treatment.
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- Patients with active infections of hepatitis B or hepatitis C viruses (the copy number of HBV DNA or HCV RNA exceeds the upper limit of the normal value); patients with active tuberculosis; patients with severe immunodeficiency diseases, human immunodeficiency virus (HIV) infection, etc.
- Patients with a history of malignant tumors within the past five years.
- Patients with a known history of severe allergy to component blood or blood products, or patients 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 childbearing plan or a sperm donation plan from the start of the study to the follow-up period and are unwilling to take contraceptive measures.
- Active infection within one week before enrollment and requiring treatment with intravenous antibiotics.
- Patients who have participated in other interventional clinical trials within three months before enrollment.
- The research physician deems that the patient's condition is not suitable for participating in this clinical study.
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, 102218
minxia Li, 86 13810136821, lyha01051@btch.edu.cn
yuehong Li
About this study
Official title: Clinical Study to Evaluate the Efficacy and Safety of Mesenchymal Stromal Cell (Amimestrocel ) in Patients With Diabetic Kidney Disease
This trial is to evaluate the efficacy and safety of umbilical cord-derived mesenchymal stromal cells (Amimestrocel ) in study subjects with progressive diabetic kidney disease (DKD), to investigate whether Amimestrocel can improve renal function or proteinuria of DKD patients.
- Conditions
- Diabetic Kidney Disease (DKD)
- Being tested
- Amimestrocel
- Keywords
- mesenchymal stromal cells(MSCs), Diabetic kidney disease (DKD)
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmimestrocelDrug
In the first month (day 1, 14, 28): 1×10^6 cells per kilogram. From the 8th to the 24th week (week 8, 12, 16, 20, 24): 1.5×10^6 cells per kilogram.
| Study group | Role | What they receive |
|---|---|---|
| Amimestrocel | Experimental | patients receive standard treatment and Amimestrocel is administered via Intravenous infusion on day 1, 14, 28, and week 8, 12, 16, 20, 24. Receives: Drug: Amimestrocel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine protein
Urine protein will be measured on 24h urine samples
Measured: Change from baseline at 24 weeks
estimated Glomerular Filtration Rate(eGFR)
GFR will be estimated by CKD-EPI
Measured: Change from baseline at 24 weeks
Secondary outcomes (12)
fasting blood glucose
fasting blood glucose
Measured: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion
HbA1c
Glycated Hemoglobin A1c
Measured: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion
Urinary Albumin/Creatinine Ratio(UACR)
UACR will be measured on spot morning urine samples
Measured: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion
proportion of outcome ( ≥50% declined in eGFR，reached end stage renal disease (ESRD), or occured Renal replacement)
proportion of outcome ( ≥50% declined in eGFR，reached End Stage Renal Disease (ESRD), or occured Renal Replacement Therapy)
Measured: proportion of study participants within outcome at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion
proportion of major adverse cardiac events(MACE) and all-cause mortality
proportion of major adverse cardiac events(MACE:CV death, non-fatal CV event(myocardial infarction, stroke, hospitalization for HF)) and all-cause mortality
Measured: proportion of study participants within outcome at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion
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 ）.
Measured: Change from baseline at 4,12,24 weeks and 12 months
changes in retinal imaging
Macular vascular density by Optical Coherence Tomography Angiography （OCTA）， and analyze the percentage of changes in retinal imaging of patients compared to the baseline .
Measured: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion
Changes in peripheral nerve injury
Examine through electromyography, to evaluate the percentage of changes in peripheral nerve injury of patients compared with the baseline.
Measured: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion
Changes in symptoms
The traditional Chinese Medicine（TCM）Syndrome Rating Scale will be used to score TCM symptoms，to evaluate the percentage of changes in the symptoms of patients compared with the baseline.
Measured: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion
Changes in the quality of life scale
The Diabetes Quality-of-Life Measure (DQOL) will be used to score quality of life at each visit, to evaluate the percentage of the change in the DQOL of patients compared to the baseline
Measured: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion
Adverse Event and Serious Adverse Event（SAE）
Measured: within 28 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 posted14 May 2025
- Study start9 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 Diabetic Kidney Disease (DKD)Studies 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
- 120 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
- NCT06969807
- Sponsor's protocol ID
- S2025-166
- Other IDs
- S2025-166-02
- Acronym
- MSC-DKD-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 Cell (Amimestrocel ) in Patients With Diabetic Kidney Disease
- ClinicalTrials.gov ID
- NCT06969807
- Acronym / sponsor ID
- MSC-DKD-001 / S2025-166
- Conditions
- Diabetic Kidney Disease (DKD)
- Keywords
- mesenchymal stromal cells(MSCs), Diabetic kidney disease (DKD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- 9 Jun 2025 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 14 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 umbilical cord-derived mesenchymal stromal cells (Amimestrocel ) in study subjects with progressive diabetic kidney disease (DKD), to investigate whether Amimestrocel can improve renal function or proteinuria of DKD 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: Amimestrocelpatients receive standard treatment and Amimestrocel is administered via Intravenous infusion on day 1, 14, 28, and week 8, 12, 16, 20, 24. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women who are ≥18 and ≤ 80 years old.
- Diagnosed with type 2 diabetes mellitus.
- Diagnosed with diabetic kidney disease based on renal pathology within the past 10 years.
- The 24-hour urine protein quantification is continuously ≥ 3.5 g, or the urine albumin-to-creatinine ratio (UACR) > 1000 mg/g.
- The estimated glomerular filtration rate (eGFR) ≥ 15 ml/min/1.73m² (calculated according to the CKD-EPI formula).
Key exclusion criteria (13 listed)
- Patients with kidney diseases not caused by diabetes mellitus.
- Patients who have received treatment with systemic immunosuppressants (such as cyclosporine A, tacrolimus, mycophenolate mofetil, etc.) within 30 days before enrollment and the duration of treatment exceeds one week.
- Severe cardiovascular diseases, such as congenital heart diseases, atrial fibrillation, NYHA class Ⅲ-IV, unstable angina pectoris, etc.
- A history of cerebral hemorrhage or cerebral infarction within the past six months (except for those with a history of lacunar cerebral infarction without residual limb movement disorders, cognitive and language function disorders).
- Patients with severe hyperlipidemia: (serum triglyceride ≥ 6.2 mmol/L, serum low-density lipoprotein cholesterol ≥ 4.1 mmol/L).
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 |
|---|---|---|
| AmimestrocelIn the first month (day 1, 14, 28): 1×10^6 cells per kilogram. From the 8th to the 24th week (week 8, 12, 16, 20, 24): 1.5×10^6 cells per kilogram. | Drug | Amimestrocel |
Primary outcome
Urine protein
Time frame: Change from baseline at 24 weeks
Urine protein will be measured on 24h urine samples
estimated Glomerular Filtration Rate(eGFR)
Time frame: Change from baseline at 24 weeks
GFR will be estimated by CKD-EPI
12 secondary outcomes
fasting blood glucose
Time frame: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion
HbA1c
Time frame: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion
Urinary Albumin/Creatinine Ratio(UACR)
Time frame: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion
proportion of outcome ( ≥50% declined in eGFR，reached end stage renal disease (ESRD), or occured Renal replacement)
Time frame: proportion of study participants within outcome at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion
proportion of major adverse cardiac events(MACE) and all-cause mortality
Time frame: proportion of study participants within outcome at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion
Mechanism exploration
Time frame: Change from baseline at 4,12,24 weeks and 12 months
changes in retinal imaging
Time frame: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion
Changes in peripheral nerve injury
Time frame: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion
Changes in symptoms
Time frame: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion
Changes in the quality of life scale
Time frame: Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion
Adverse Event and Serious Adverse Event（SAE）
Time frame: within 28 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.
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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 Diabetic Kidney Disease (DKD), 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 8 inclusion and 13 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 (+86 010 66935462, liping.8@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine protein (time frame: Change from baseline at 24 weeks). The study lists 2 primary outcomes in all. 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.