Not yet recruitingNCT07769671Updated Aug 18, 2026

Human Umbilical Cord Mesenchymal Stem Cell Infusion for Type 2 Diabetic Nephropathy

A Phase 1/2 interventional study of Human umbilical cord mesenchymal stem cell injection in Diabetic Nephropathy Type 2, sponsored by The First People's Hospital of Changzhou. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by The First People's Hospital of Changzhou · Phase 1/2, Interventional, and Treatment

Phase: Phase 1/2
Study type: Interventional
Enrollment: 49
Allocation: Randomized
Ages: 18 Years to 80 Years
Sex: All

Study summary

Diabetic nephropathy (DN) is a chronic kidney disease caused by diabetes. It is one of the most common and most serious microvascular complications of diabetes. Current treatment options for DN are limited. Mesenchymal stem cells (MSCs) are considered one of the promising treatments for DN. This study aims to evaluate the safety, tolerability, and preliminary efficacy of human umbilical cord mesenchymal stem cell injection in patients with type 2 DN.

Read the detailed description

This is a Phase I/IIa clinical trial evaluating the safety, tolerability, and preliminary efficacy of human umbilical cord mesenchymal stem cell injection in patients with type 2 DN. Phase I is a single-center, prospective, open-label, self-controlled study to evaluate the safety and tolerability of MSCs and determine the recommended Phase II dose (RP2D). Phase IIa is a randomized, open-label, standard treatment-controlled study to preliminarily evaluate efficacy.

Conditions studied

Diabetic Nephropathy Type 2

Who can participate

Ages eligible: 18 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Aged 18 to 80 years, with no gender and ethnicity restrictions.
Patients who meet the diagnostic criteria for type 2 diabetes mellitus (T2DM) as defined by the Chinese Guideline for the Prevention and Treatment of Type 2 Diabetes Mellitus (2020 Edition), with:
1. Baseline serum C-peptide concentrations ranging from 0.3 to 3.0 ng/mL;
2. Stable antihyperglycemic and antihypertensive medication regimen for at least 3 months prior to screening, defined as dosage adjustment less than 25%.
Urinary albumin-to-creatinine ratio (UACR) ≥ 30 and ≤ 5000 mg/g together with estimated glomerular filtration rate (eGFR) ≥ 30 and \< 90 mL/min/1.73 m².
Patients are required to have renal biopsy-proven DN glomerulopathy with Tervaert Class IIa to Class III glomerular lesions.
Patients voluntarily agree to participate and provide written informed consent after full disclosure of the study's purpose, procedures, nature, and potential adverse reactions.

Exclusion criteria

Exclusion Criteria:

Other non-T2DM, such as type 1 diabetes.
Individuals allergic to MSCs or their preservation solution.
Individuals with any of the following conditions during screening:
1. History of acute diabetic complications within the past 6 months, including diabetic ketoacidosis, hyperglycemic hyperosmolar state, or lactic acidosis;
2. Unstable disease status or severe diabetic complications within the past 6 months, such as proliferative diabetic retinopathy or macular edema, severe diabetic neuropathy, intermittent claudication, active diabetic foot lesions;
3. History of three or more Level 3 hypoglycemic events within the past 6 months, as defined by the Guidelines for the Management of Type 2 Diabetes in China (2020 Edition);
4. History of any of the following cardiac conditions within the past 6 months: decompensated heart failure (New York Heart Association Class III-IV); unstable angina, myocardial infarction, coronary artery bypass grafting, or coronary stent implantation; severe arrhythmias requiring treatment, including second-degree or third-degree atrioventricular block, long QT syndrome, or QTc interval prolongation ≥ 500 ms, and deemed by the investigator to render the subject unsuitable for study participation;
5. History of hemorrhagic or ischemic stroke within the past 6 months deemed by the investigator to render the subject unsuitable for study participation;
6. History of other severe endocrine disorders affecting glucose metabolism, such as multiple endocrine neoplasia, acromegaly, and Cushing's syndrome, deemed by the investigator to render the subject unsuitable for study participation;
7. History of severe digestive system diseases, nutritional and metabolic disorders, or rheumatologic diseases, deemed by the investigator to render the subject unsuitable for study participation;
8. Concurrent malignancy or history of malignancy (except malignancies with at least 5 years of disease-free survival);
9. Severe psychiatric disorder or speech impairment, or the subject is unwilling or unable to fully understand and comply with study requirements;
10. Severe infection or major surgery within the past 6 months, deemed by the investigator to render the subject unsuitable for study participation;
11. Acquired Immunodeficiency Syndrome, active hepatitis B, hepatitis C infection, or other acute or chronic infectious diseases;
12. Poorly controlled blood pressure, defined as a systolic blood pressure > 180mmHg and/or diastolic blood pressure > 110mmHg.
Laboratory test results meet the following criteria:
1. Alanine aminotransferase or aspartate aminotransferase ≥ 2.5 times the upper limit of normal (ULN);
2. Total bilirubin ≥ 2.0 times ULN;
3. Currently suffering from severe renal disease, or eGFR (CKD-EPI2012Scr-CysC) \< 30 mL/min/1.73 m²;
4. Fasting triglycerides > 5.6 mmol/L;
5. Serum amylase or serum lipase ≥ 1.5 times ULN;
6. Hemoglobin \< 10.0 g/dL (100 g/L), serum albumin \< 30 g/L;
7. Glycosylated hemoglobin ≥ 10%.
History of long-term systemic corticosteroid administration (consecutive or cumulative ≥ 7 days) within 1 month prior to screening (including but not limited to intravenous administration, oral administration, or intramuscular injection).
Renal replacement therapy within 3 months prior to screening, current ongoing, or planned initiation within the next 3 months (including hemodialysis, peritoneal dialysis, continuous renal replacement therapy).
Participation in other drug or device clinical trials within 3 months prior to screening.
Previous use of other stem cell treatments.
Use of immunosuppressants, tripterygium glycosides, eplerenone, spironolactone, or similar agents within 3 months prior to screening.
Pregnancy, lactation, or intention to become pregnant during the study period.
Any other condition that, in the investigator's judgment, would make the subject unsuitable for the study.
Renal biopsy revealing DN with coexisting non-DN pathology.

Study design

Phase: Phase 1 / Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 49 participants (estimated)

Study arms

Experimental
Phase I MSCs treatment group
Patients will receive human umbilical cord mesenchymal stem cells (MSCs) injection in addition to standard treatment (lifestyle management, glycemic control, blood pressure control, urinary protein control, lipid regulation, and uric acid control).
Biological: Human umbilical cord mesenchymal stem cell injection
Experimental
Phase IIa MSCs treatment group
Patients will receive MSCs injection in addition to standard treatment (lifestyle management, glycemic control, blood pressure control, urinary protein control, lipid regulation, and uric acid control).
Biological: Human umbilical cord mesenchymal stem cell injection
No intervention
Phase IIa standard treatment control group
Patients will receive standard treatment (lifestyle management, glycemic control, blood pressure control, urinary protein control, lipid regulation, and uric acid control).

Interventions

BiologicalHuman umbilical cord mesenchymal stem cell injection
Participants will receive intravenous infusions of allogeneic human umbilical cord MSCs in addition to standard treatment. Phase I will evaluate three dose levels (0.5×10\^6/kg, 1.0×10\^6/kg and 2.0×10\^6/kg). Phase IIa will use dose level 1.0×10\^6/kg, subject to adjustment based on Phase I results. Each 6-week treatment cycle will include three infusions administered at 2-week intervals, for a total of three treatment cycles.

What researchers measure

Primary outcomes

Phase I: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormalities in vital signs, electrocardiogram (ECG), and laboratory tests
AEs and SAEs will be graded according to the NCI-CTCAE version 5.0. Changes in vital signs, ECG, and routine laboratory tests will be monitored throughout the study. The recommended Phase II dose (RP2D) will be determined from Phase I results.
Time frame: From enrollment to 6 months after the end of treatment
Phase IIa: Proportion of participants achieving marked response or moderate response to human umbilical cord mesenchymal stem cell injection for type 2 DN
Marked response is defined as significant improvement in clinical symptoms together with complete remission of proteinuria \[urinary albumin-to-creatinine ratio (UACR) \<30 mg/g\], or significant improvement in estimated glomerular filtration rate (eGFR) (serum creatinine reduced by ≥20%). Moderate response is defined as partial alleviation of clinical symptoms and partial remission of proteinuria without complete resolution; either the UACR or 24-hour urinary protein level decreases by ≥50%, or eGFR improves (serum creatinine reduced by ≥10%). No response is defined as no improvement in clinical symptoms and no remission of proteinuria. The reduction of either UACR or 24-hour urinary protein level is less than 50%, and there is no improvement in eGFR (serum creatinine reduced by \<10%).
Time frame: From enrollment to 6 months after the end of treatment

Secondary outcomes

Phase I: Proportion of participants achieving marked response or moderate response to human umbilical cord mesenchymal stem cell injection for type 2 DN
Marked response is defined as significant improvement in clinical symptoms together with complete remission of proteinuria \[UACR\<30 mg/g\], or significant improvement in eGFR (serum creatinine reduced by ≥20%). Moderate response is defined as partial alleviation of clinical symptoms and partial remission of proteinuria without complete resolution; either the UACR or 24-hour urinary protein level decreases by ≥50%, or eGFR improves (serum creatinine reduced by ≥10%). No response is defined as no improvement in clinical symptoms and no remission of proteinuria. The reduction of either UACR or 24-hour urinary protein level is less than 50%, and there is no improvement in eGFR (serum creatinine reduced by \<10%).
Time frame: From enrollment to 6 months after the end of treatment
Phase IIa: Incidence and severity of AEs and serious SAEs and clinically significant abnormalities in vital signs, ECG, and laboratory tests
AEs and SAEs will be graded according to the NCI-CTCAE version 5.0. Changes in vital signs, ECG, and routine laboratory tests will be monitored throughout the study.
Time frame: From enrollment to 6 months after the end of treatment
Renal function
Changes in serum creatinine, blood urea nitrogen, eGFR
Time frame: From enrollment to 6 months after the end of treatment
24-Hour urinary protein quantification
Change in 24-hour urinary protein quantification
Time frame: From enrollment to 6 months after the end of treatment
UACR
Change in UACR
Time frame: From enrollment to 6 months after the end of treatment
Glycated hemoglobin (HbA1c)
Change in HbA1c
Time frame: From enrollment to 6 months after the end of treatment
Fasting blood glucose
Change in fasting blood glucose
Time frame: From enrollment to 6 months after the end of treatment
2-Hour postprandial blood glucose
Change in 2-hour postprandial blood glucose
Time frame: From enrollment to 6 months after the end of treatment
Fasting insulin
Change in fasting insulin
Time frame: From enrollment to 6 months after the end of treatment
Fasting C-Peptide
Change in fasting C-peptide
Time frame: From enrollment to 6 months after the end of treatment
Fasting lipid profile
Changes in triglycerides, total cholesterol, high-density lipoprotein cholesterol, and low-density lipoprotein cholesterol
Time frame: From enrollment to 6 months after the end of treatment
Serum albumin
Change in serum albumin
Time frame: From enrollment to 6 months after the end of treatment
Oral glucose tolerance test (OGTT)
Changes in OGTT measurements collected after overnight fasting
Time frame: From enrollment to 6 months after the end of treatment
C-peptide release test
Changes in C-peptide release test measurements collected after overnight fasting
Time frame: From enrollment to 6 months after the end of treatment
Fasting body weight
Change in fasting body weight
Time frame: From enrollment to 6 months after the end of treatment
Body mass index
Body mass index is calculated as weight (kg) divided by height squared (m²), with results in kg/m².
Time frame: From enrollment to 6 months after the end of treatment
Waist circumference
Change in waist circumference
Time frame: From enrollment to 6 months after the end of treatment
Hip Circumference
Change in hip circumference
Time frame: From enrollment to 6 months after the end of treatment
Waist-to-hip ratio
Waist-to-hip ratio is calculated as waist circumference divided by hip circumference, with results as a dimensionless value.
Time frame: From enrollment to 6 months after the end of treatment

Other outcomes

T cell subsets
Changes in CD4+ T cells, and CD8+ T cells (assessed in Phase IIa only)
Time frame: From enrollment to 6 months after the end of treatment
Pro-inflammatory cytokines
Changes in IL-1, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, TNF-α, IFN-γ, and IFN-α (assessed in Phase IIa only)
Time frame: From enrollment to 6 months after the end of treatment

Study locations

1 site

The First People's Hospital of Changzhou
Changzhou, Jiangsu 213000, China
- Fei Hua · Contact · Huafei1970@suda.cn · +86-051968870000

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be shared due to privacy and confidentiality considerations.

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT07769671
Lead sponsor: The First People's Hospital of Changzhou
Responsible party: Sponsor
First posted: Aug 18, 2026
Start date: Sep 1, 2026 (estimated)
Primary completion: Jun 30, 2029 (estimated)
Completion: Aug 31, 2029 (estimated)
Last update: Aug 18, 2026

Study contacts

Fei Hua

Contact

Huafei1970@suda.cn

+86-051968870000

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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