Umbilical Cord Mesenchymal Stem Cells Therapy for Diabetic Nephropathy

NCT04125329 | Unknown Early Phase 1

• 1 other identifier: 43136152-9
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Mesenchymal Stem Cells; Diabetic Nephropathy

Keywords

Human umbilical cord mesenchymal stem cells; Diabetic nephropathy

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent and Treatment-Chronic Adverse Events of human umbilical cord mesenchymal stem cells for diabetic nephropathy patient

  The patient's discomfort and clinical symptoms during the study were recorded, as well as the related laboratory test indicators and physical examination abnormalities of the subjects during the study.Describe the association with umbilical cord mesenchymal stem cell therapy and calculate the incidence of treatment-related acute and chronic adverse events.

  60 weeks

Secondary Outcomes (1)

• Changes in eGFR before and after treatment; Changes in 24h urine protein quantification before and after treatment

  60Weeks,but the major evaluated time is 12 weeks after the last treatment, compared with baseline (0W)

Study Arms (1)

Human umbilical cord mesenchymal stem cells

EXPERIMENTAL

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

Drug: Human umbilical cord mesenchymal stem cells

Interventions

Human umbilical cord mesenchymal stem cells 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

Human umbilical cord mesenchymal stem cells

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may not qualify if:

• 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;

Sponsors & Collaborators

• Yan'an Affiliated Hospital of Kunming Medical University: lead

Study Sites (1)

Yan'an Hospital of Kunming City

Kunming, 650051, China

RECRUITING

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Central Study Contacts

wang xiaodan

CONTACT

0871-63211326; 52830538@qq.com

Tang zhe

CONTACT

0871-63211272

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: October 14, 2019
• Study Start: April 1, 2020
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)