Diabetic NephropathyPhase 1NCT07822152
Human Umbilical Cord Mesenchymal Stem Cell Injection for Diabetic Nephropathy
A Phase 1 study testing UC-MSCs in people with Diabetic Nephropathy, run by Tongji Hospital at 1 site in China.
Trial summary
Diabetic nephropathy (DN) is one of the most significant microvascular complications of diabetes mellitus. Its incidence can reach 30%-40% after 20 years of diabetes duration, among which 5%-10% of patients will progress to end-stage renal disease, where renal function is essentially lost, and only hemodialysis or… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- UC-MSCs
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 25 Mar 2026to 25 Mar 2028
- Phase
- Phase 1
- 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 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes with a disease duration of ≥ 5 years (no age limit for subjects diagnosed with diabetic nephropathy by renal biopsy).
- Age 30-70 years, no gender restriction.
- Diagnosis of diabetic nephropathy (see Appendix 1).
- Estimated glomerular filtration rate (eGFR) between 15 and 60 mL/min/1.73 m².
- During the 3-month period prior to enrollment, received antihypertensive therapy centered on renin-angiotensin system inhibitors (RASIs) to control blood pressure, achieving the following targets: systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤ 100 mmHg.
- At the screening/baseline visit, must have received a stable dose of an SGLT2 inhibitor (empagliflozin, dapagliflozin, canagliflozin, or ertugliflozin) for ≥ 3 months, or a stable dose of nateglinide for ≥ 3 months, or a stable combination of an SGLT2 inhibitor and nateglinide for ≥ 3 months, and continue the same stable dose throughout the trial.
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- No positive exclusion criteria.
- Voluntary participation in the clinical trial, good compliance, ability to understand and sign the informed consent form for this study, and capability to complete the entire trial treatment and follow-up schedule according to the study protocol.
- (Final eligibility will be determined by the investigator based on comprehensive clinical symptom assessment.)
Who cannot join
- Patients with type 1 diabetes mellitus.
- Patients with a prior history of primary glomerulonephritis, lupus nephritis, ANCA-associated vasculitis with renal involvement, Henoch-Schönlein purpura nephritis, or hepatitis B-associated nephritis.
- Poor glycemic control.
- Active liver disease or significantly abnormal liver function test results (ALT or AST ≥ 2× the upper limit of normal).
- Presence of autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, etc.
- White blood cell count < 3.0×10⁹/L, hemoglobin < 80 g/L, platelet count < 100×10⁹/L, or other hematologic disorders (severe anemia, idiopathic thrombocytopenic purpura, splenomegaly, coagulation disorders, etc.).
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- Severe and unstable cardiovascular or cerebrovascular disease (as assessed by the investigator).
- Uncontrolled infection or a history of tuberculosis.
- Current or previous malignancy; patients with tumor markers exceeding 1× the upper limit of normal.
- Current or previous blood-borne infectious diseases (HIV, syphilis, hepatitis B, and hepatitis C).
- Pregnancy, planned pregnancy, or possibility of breastfeeding.
- Use of systemic corticosteroids (e.g., cortisone, hydrocortisone, prednisone, prednisolone, methylprednisolone, dexamethasone, betamethasone, beclomethasone, triamcinolone acetonide) within 3 months prior to screening; use of systemic immunosuppressive agents other than corticosteroids (e.g., cyclosporine A, cyclophosphamide, rituximab, mycophenolate mofetil, mycophenolate sodium, leflunomide, azathioprine) within 12 months prior to screening; use of hydroxychloroquine within 8 months prior to screening; use of tacrolimus within 3 months prior to screening. Exceptions: topical, ocular, intra-articular, intranasal, and inhaled corticosteroids; short-term continuous use (≤3 days) of corticosteroids for non-autoimmune conditions or to prevent possible allergic reactions to the study drug (e.g., a single injection of 3 mg dexamethasone to prevent allergy).
- Allergy to human albumin.
- Psychiatric disorders that may affect voluntariness, decision-making ability, or communication ability.
- History of known drug abuse.
- Participation in another clinical trial within the last 3 months.
- Prior treatment with stem cell therapy.
- Severe uncontrolled pulmonary disease, including pulmonary fibrosis, interstitial lung disease, acute exacerbation of chronic obstructive pulmonary disease, active pulmonary infection, etc.
- Poor compliance, inability to complete the entire study.
- Patients deemed unsuitable for the study by the investigator.
- Appendix 1:
- After establishing diabetes mellitus as the cause of renal injury and excluding other causes of chronic kidney disease, the diagnosis of diabetic kidney disease (DKD) can be established upon meeting at least one of the following criteria:
- At least 2 out of 3 measurements within a 3- to 6-month period show a urine albumin-to-creatinine ratio (UACR) ≥30 mg/g or a 24-hour urinary albumin excretion rate (UAER) ≥30 mg/24 h;
- eGFR <60 mL/min/1.73 m² persisting for more than 3 months;
- Renal biopsy findings are consistent with the pathological changes characteristic of diabetic kidney disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, WUHAN, HUBEI
Wuhan
GANG XU, +86 13507181312, xugang@tjh.tjmu.edu.cn
About this study
Official title: A Single-Center, Open-Label, Dose-Escalation Phase I Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection for Diabetic Nephropathy
Diabetic nephropathy (DN) is one of the most significant microvascular complications of diabetes mellitus. Its incidence can reach 30%-40% after 20 years of diabetes duration, among which 5%-10% of patients will progress to end-stage renal disease, where renal function is essentially lost, and only hemodialysis or kidney transplantation can sustain or save lives.
Given the current lack of effective clinical measures for treating diabetic nephropathy, exploring new strategies for its prevention and treatment is of great significance. Diabetic nephropathy is caused by persistent hyperglycemia, and its key pathological features include chronic inflammatory cell infiltration in kidney tissue, podocyte apoptosis in the glomeruli, pyroptosis of renal tubular epithelial cells, and renal fibrosis. Therefore, the key to treating diabetic nephropathy lies in inhibiting chronic renal inflammation and alleviating the resulting tissue and cell damage; reducing glomerular podocyte apoptosis and renal tubular epithelial cell pyroptosis, lowering proteinuria levels, and delaying the pathological progression of diabetic nephropathy; suppressing renal fibrosis; and regenerating new renal tissue cells to partially restore renal tissue structure and function.
Current clinical treatments for diabetic nephropathy primarily involve strict glycemic control and the use of angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists. Numerous clinical studies have shown that these therapeutic measures can only partially delay the onset and slow the progression of diabetic nephropathy, but cannot reverse renal damage. Accumulating evidence indicates that mesenchymal stem cells (MSCs) can migrate and home to injured kidney tissues, directionally differentiate into renal parenchymal cells to repair and regenerate damaged tissue cells; secrete nutritional factors to improve local blood supply and the microenvironment of renal tissue; and release anti-inflammatory and immunomodulatory factors, exerting potent anti-inflammatory and immunomodulatory effects, thereby reducing inflammatory injury and apoptosis of renal tissue cells and alleviating renal fibrosis. Therefore, mesenchymal stem cells have emerged as a new hope for the treatment of diabetic nephropathy.
- Conditions
- Diabetic Nephropathy
- Being tested
- UC-MSCs, Placebo
- Keywords
- Human umbilical cord mesenchymal stem cell
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UC-MSCsDrug
UC-MSCs :5*10E5、1*10E6、2*10E6 UC-MSCs/kg body weight/100mL saline containing 1% human albumin
PlaceboDrug
saline containing 1% human albumin/100mL
| Study group | Role | What they receive |
|---|---|---|
| UC-MSCs | Experimental | Not described Receives: Drug: UC-MSCs |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
The number of Adverse Events associated with UC-MSCs intervention per treatment arm
Measured: From Baseline (0 W) to 48 weeks after treatment
Secondary outcomes (7)
Kidney function
Change in GFR from baseline
Measured: From Baseline (0 W) to 24 weeks after treatment
Kidney function
Change in cystatin C from baseline
Measured: From Baseline (0 W) to 48 weeks after treatment
Kidney function
Change in serum creatinine from baseline
Measured: From Baseline (0 W) to 48 weeks after treatment
Kidney function
Change in eGFR from baseline.
Measured: From Baseline (0 W) to 48 weeks after treatment
Kidney function
Change in 24-hour urinary protein from baseline
Measured: From Baseline (0 W) to 48 weeks after treatment
Kidney function
Change in urine albumin/creatinine ratio from baseline
Measured: From Baseline (0 W) to 48 weeks after treatment
Change in HbA1c
Change in Glycosylated Hemoglobin (HbA1c) from baseline
Measured: From Baseline (0 W) to 48 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2026
- Study start25 Mar 2026
- Primary completion25 Mar 2028 (estimated)
- Study completion25 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- More trials run by Tongji 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Hamilton Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, Gang Xu, Tongji Hospital
- Investigators
- GANG XU, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07822152
- Sponsor's protocol ID
- TongjiHospital xugangtjh
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After approval from the steering committee and the Human Genetic Resources Administration of China, this trial data can be shared with qualifying researchers who submit a proposal with a valuable research question. A contract should be signed.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label, Dose-Escalation Phase I Clinical Trial of Human Umbilical Cord Mesenchymal Stem Cell Injection for Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT07822152
- Acronym / sponsor ID
- TongjiHospital xugangtjh
- Conditions
- Diabetic Nephropathy
- Keywords
- Human umbilical cord mesenchymal stem cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Wuhan Hamilton Biotechnology Co., Ltd.
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 25 Mar 2028 (estimated)
- Study completion
- 25 Mar 2028 (estimated)
- First posted
- 16 Sep 2026 (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.
Diabetic nephropathy (DN) is one of the most significant microvascular complications of diabetes mellitus. Its incidence can reach 30%-40% after 20 years of diabetes duration, among which 5%-10% of patients will progress to end-stage renal disease, where renal function is essentially lost, and only hemodialysis or kidney transplantation can sustain or save lives.
Given the current lack of effective clinical measures for treating diabetic nephropathy, exploring new strategies for its prevention and treatment is of great significance. Diabetic nephropathy is caused by persistent hyperglycemia, and its key pathological features include chronic inflammatory cell infiltration in kidney tissue, podocyte apoptosis in the glomeruli, pyroptosis of renal tubular epithelial cells, and renal fibrosis. Therefore, the key to treating diabetic nephropathy lies in inhibiting chronic renal inflammation and alleviating the resulting tissue and cell damage; reducing glomerular podocyte apoptosis and renal tubular epithelial cell pyroptosis, lowering proteinuria levels, and delaying the pathological progression of diabetic nephropathy; suppressing renal fibrosis; and regenerating new renal tissue cells to partially restore renal tissue structure and function.
Current clinical treatments for diabetic nephropathy primarily involve strict glycemic control and the use of angiotensin-converting enzyme inhibitors or angiotensin II receptor antagonists. Numerous clinical studies have shown that these therapeutic measures can only partially delay the onset and slow the progression of diabetic nephropathy, but cannot reverse renal damage. Accumulating evidence indicates that mesenchymal stem cells (MSCs) can migrate and home to injured kidney tissues, directionally differentiate into renal parenchymal cells to repair and regenerate damaged tissue cells; secrete nutritional factors to improve local blood supply and the microenvironment of renal tissue; and release anti-inflammatory and immunomodulatory factors, exerting potent anti-inflammatory and immunomodulatory effects, thereby reducing inflammatory injury and apoptosis of renal tissue cells and alleviating renal fibrosis. Therefore, mesenchymal stem cells have emerged as a new hope for the treatment of diabetic nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UC-MSCs | Experimental | Drug: UC-MSCs |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Type 2 diabetes with a disease duration of ≥ 5 years (no age limit for subjects diagnosed with diabetic nephropathy by renal biopsy).
- Age 30-70 years, no gender restriction.
- Diagnosis of diabetic nephropathy (see Appendix 1).
- Estimated glomerular filtration rate (eGFR) between 15 and 60 mL/min/1.73 m².
- During the 3-month period prior to enrollment, received antihypertensive therapy centered on renin-angiotensin system inhibitors (RASIs) to control blood pressure, achieving the following targets: systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤ 100 mmHg.
Key exclusion criteria (25 listed)
- Patients with type 1 diabetes mellitus.
- Patients with a prior history of primary glomerulonephritis, lupus nephritis, ANCA-associated vasculitis with renal involvement, Henoch-Schönlein purpura nephritis, or hepatitis B-associated nephritis.
- Poor glycemic control.
- Active liver disease or significantly abnormal liver function test results (ALT or AST ≥ 2× the upper limit of normal).
- Presence of autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, etc.
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 |
|---|---|---|
| UC-MSCsUC-MSCs :5*10E5、1*10E6、2*10E6 UC-MSCs/kg body weight/100mL saline containing 1% human albumin | Drug | UC-MSCs |
| Placebosaline containing 1% human albumin/100mL | Drug | Placebo |
Primary outcome
Adverse Events
Time frame: From Baseline (0 W) to 48 weeks after treatment
The number of Adverse Events associated with UC-MSCs intervention per treatment arm
7 secondary outcomes
Kidney function
Time frame: From Baseline (0 W) to 24 weeks after treatment
Kidney function
Time frame: From Baseline (0 W) to 48 weeks after treatment
Kidney function
Time frame: From Baseline (0 W) to 48 weeks after treatment
Kidney function
Time frame: From Baseline (0 W) to 48 weeks after treatment
Kidney function
Time frame: From Baseline (0 W) to 48 weeks after treatment
Kidney function
Time frame: From Baseline (0 W) to 48 weeks after treatment
Change in HbA1c
Time frame: From Baseline (0 W) to 48 weeks after treatment
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 16 Sep 2026.
- Individual participant dataSharing planned: Yes. After approval from the steering committee and the Human Genetic Resources Administration of China, this trial data can be shared with qualifying researchers who submit a proposal with a valuable research question. A contract should be signed.
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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.
GANG XU principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing UC-MSCs in people with Diabetic Nephropathy, run by Tongji Hospital at 1 site 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 9 inclusion and 25 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 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 RUI ZENG (+8602783665516, zengrui@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: From Baseline (0 W) to 48 weeks after treatment). 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 16 Sep 2026.