Umbilical Cord Mesenchymal Stem Cells Therapy for Diabetic Nephropathy

NCT ID: NCT04125329

Last Updated: 2021-04-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2024-09-01

Brief Summary

This clinical trial assessed the safety of human umbilical cord mesenchymal stem cell therapy in 15 patients with diabetic nephropathy. Fifteen subjects received umbilical cord mesenchymal stem cell therapy 3 times. Approximately 1 × 106/kg of human umbilical cord mesenchymal stem cells were administered by peripheral intravenous infusion once a month .Endpoints:Primary endpoint: Safety and adverse events (safety and tolerability of umbilical cord mesenchymal stem cell therapy within 60 weeks).Secondary endpoint indicators:Efficacy measures: eGFR, urinary albumin-to-creatinine ratio, and percentage changes of 24-h urinary protein quantities from baseline to 60 weeks.

Detailed Description

Dosage and administration method: Fifteen subjects received umbilical cord mesenchymal stem cell therapy 3 times. Approximately 1 × 106/kg of human umbilical cord mesenchymal stem cells were administered by peripheral intravenous infusion once a month at 0, 4, and 8 weeks. Routine medications were used.

Follow-up: Patient follow-up was performed 7 times at 0, 4, 8, 20, 32, 48, and 60 weeks. Blood and urine were collected for determination of urinary albumin-to-creatinine ratio, 24-h urine protein ratio, liver and kidney function, fasting blood glucose, 2-h postprandial blood glucose, glycosylated hemoglobin, eGFR, blood lipids, and blood electrolytes at each follow-up visit. The daily dose of insulin was recorded. Blood samples were taken after each infusion of stem cells for flow cytometry and for the detection of CD3, CD4, CD8, CD28+, Treg, CD80, CD86, HLA-DR, CD83, and CD1a cells. Plasma levels of the cytokines IFN-gamma, TNF, IL-2, IL-4, IL-10, IL-6, IL-12P70, IL-8, and IL-1 beta were also determined.

Endpoints:

Primary endpoint: Safety and adverse events (safety and tolerability of umbilical cord mesenchymal stem cell therapy within 60 weeks): The number and severity of adverse events, an evaluation of their association with the umbilical cord mesenchymal stem cell treatment, and the outcome of the adverse events.

The patients' discomfort and clinical symptoms during the study period were recorded.

The subjects' relevant laboratory test indices, 12-lead electrocardiogram, vital signs, and physical examination results were recorded during the study.

Secondary endpoint indicators:

Efficacy measures: eGFR, urinary albumin-to-creatinine ratio, and percentage changes of 24-h urinary protein quantities from baseline to 60 weeks.

Data analysis:

The number of adverse events and the number of severity adverse events were determined based on the changes in the data summary (i.e., descriptive statistics).

A multilevel statistical analysis model (mixed effects model) was used to infer the relationship between treatment factors and key indicators, reflect the changing trend of key indicators in different time periods, and draw statistical analysis conclusions.

Conditions

Mesenchymal Stem Cells; Diabetic Nephropathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Human umbilical cord mesenchymal stem cells

Human umbilical cord mesenchymal stem cells were given to each diabetic nephropathy subject once a month, peripheral intravenous injection, a total of three times

Group Type: EXPERIMENTAL

Human umbilical cord mesenchymal stem cells

Intervention Type: DRUG

Human umbilical cord mesenchymal stem cells were given to each diabetic nephropathy subject once a month, peripheral intravenous injection, a total of three times

Interventions

Human umbilical cord mesenchymal stem cells

Human umbilical cord mesenchymal stem cells were given to each diabetic nephropathy subject once a month, peripheral intravenous injection, a total of three times

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

• Patients with kidney biopsy diagnosis of type I diabetic nephropathy or a diagnosis of another glomerular disease;
• Patients with abnormal renal function (serum creatinine ≥ the upper limit of normal);
• Patients with HbA1c ≥10%;
• Patients with active liver disease or abnormal liver function test results (ALT or AST ≥2 times the upper limit of normal);
• Patients with blood leukocyte count <3.0 × 109/L, hemoglobin <90 g/L, platelet count <100 × 109/L, or those who have other hematologic diseases (severe anemia, idiopathic thrombocytopenic purpura, splenomegaly, coagulation dysfunction, etc.);
• Patients with serious and unstable cardiovascular or cerebrovascular diseases (unstable angina pectoris, coronary artery disease, cerebrovascular disease, transient ischemic attack, congestive heart failure, etc.), acute and difficult to control the disease, after treatment has not been effectively controlled severe hypertension (blood pressure >160/100 mm Hg), or organ transplantation;
• Patients with increased use of hypotensive drugs in the past 3 months;
• Patients with uncontrolled infection;
• Patients with tumors or abnormal tumor marker levels;
• Patients with blood-borne diseases (i.e., HIV, syphilis, hepatitis B, and hepatitis C);
• Pregnancy, the potential for pregnancy, or lactation;
• Patients receiving immunosuppressive therapy;
• Patients with a history of allergy, especially patients allergic to human blood albumin;
• Patients with mental illness affecting their voluntarism, ability to make decisions, and ability to communicate；
• A history of alcoholism or known drug addiction in the last 2 years;
• Participation in another clinical trial within the last 3 months;
• Patients judged inappropriate for this study by the physicians.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yan'an Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Yan'an Hospital of Kunming City

Kunming, , China

Site Status: RECRUITING

Countries

China

Central Contacts

wang xiaodan

Role: CONTACT

52830538@qq.com

0871-63211326

Tang zhe

Role: CONTACT

0871-63211272

Facility Contacts

Zhouliu Hou

Role: primary

hzl579@163.com

0871-63211326

Other Identifiers

43136152-9

Identifier Type: -

Identifier Source: org_study_id