Clinical trial for Diabetic Nephropathy
Official title Human Umbilical Cord Mesenchymal Stem Cell Injection for Diabetic Nephropathy
ClinicalTrials.gov ID: NCT07822152
What this study is testing
What is UC-MSCs?
UC-MSCs is an investigational medicine, being studied as a potential treatment for diabetic nephropathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 70
You may be able to join if
- Type 2 diabetes with a disease duration of ≥ 5 years (no age limit for people 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...
You likely can't join if
- Voluntary participation in the clinical trial, good compliance, ability to understand and sign the informed consent form for this study, and...
- Patients with type 1 diabetes mellitus.
- Patients with a prior history of primary glomerulonephritis, lupus nephritis, ANCA-associated vasculitis with renal involvement, Henoch-Schönlein...
- 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.
See the full eligibility criteria
- Type 2 diabetes with a disease duration of ≥ 5 years (no age limit for people 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...
- 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...
- No positive
- 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...
- 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.).
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.