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

NCT07769671 | Not Yet Recruiting Phase 1

• 1 other identifier: CZGXB-2022001
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetic Nephropathy Type 2

Outcome Measures

Primary Outcomes (2)

• 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.

  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%).

  From enrollment to 6 months after the end of treatment

Secondary Outcomes (19)

• Phase I: Proportion of participants achieving marked response or moderate response to human umbilical cord mesenchymal stem cell injection for type 2 DN

  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

  From enrollment to 6 months after the end of treatment

• Renal function

  From enrollment to 6 months after the end of treatment

• 24-Hour urinary protein quantification

  From enrollment to 6 months after the end of treatment

• UACR

  From enrollment to 6 months after the end of treatment

Other Outcomes (2)

• T cell subsets

  From enrollment to 6 months after the end of treatment

• Pro-inflammatory cytokines

  From enrollment to 6 months after the end of treatment

Study Arms (3)

Phase I MSCs treatment group

EXPERIMENTAL

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

Phase IIa MSCs treatment group

EXPERIMENTAL

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

Phase IIa standard treatment control group

NO INTERVENTION

Patients will receive standard treatment (lifestyle management, glycemic control, blood pressure control, urinary protein control, lipid regulation, and uric acid control).

Interventions

Human umbilical cord mesenchymal stem cell injection BIOLOGICAL

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.

Phase I MSCs treatment group; Phase IIa MSCs treatment group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Baseline serum C-peptide concentrations ranging from 0.3 to 3.0 ng/mL;
• 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.

You may not qualify if:

• 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:
• History of acute diabetic complications within the past 6 months, including diabetic ketoacidosis, hyperglycemic hyperosmolar state, or lactic acidosis;
• 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;
• 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);
• 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;
• History of hemorrhagic or ischemic stroke within the past 6 months deemed by the investigator to render the subject unsuitable for study participation;
• 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;
• 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;
• Concurrent malignancy or history of malignancy (except malignancies with at least 5 years of disease-free survival);
• Severe psychiatric disorder or speech impairment, or the subject is unwilling or unable to fully understand and comply with study requirements;
• Severe infection or major surgery within the past 6 months, deemed by the investigator to render the subject unsuitable for study participation;
• Acquired Immunodeficiency Syndrome, active hepatitis B, hepatitis C infection, or other acute or chronic infectious diseases;
• Poorly controlled blood pressure, defined as a systolic blood pressure \> 180mmHg and/or diastolic blood pressure \> 110mmHg.

Sponsors & Collaborators

• The First People's Hospital of Changzhou: lead

Study Sites (1)

The First People's Hospital of Changzhou

Changzhou, Jiangsu, 213000, China

Location

Central Study Contacts

Fei Hua

CONTACT

+86-051968870000; Huafei1970@suda.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 18, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): August 31, 2029
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)