Clinical Research of UC-MSCs in the Treatment of Diabetic Nephropathy

NCT04562025 | Unknown DMC

• 1 other identifier: 20200915HMD
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic nephropathy (DN) is one of the most serious complications of diabetes and the leading cause of end-stage chronic kidney disease. DN is a refractory disease with low awareness, high incidence, and high disability. The incidence of DN can reach 30 to 40% after 20 years of diabetes, of which 5\~10% of patients will progress to end-stage renal disease, and epidemiological surveys predict that by 2030, DN will become the seventh leading cause of death in the world. Currently, there are no effective drugs for treating DN. This clinical trial is to inspect the safety and efficiency of human umbilical cord mesenchymal stem cells (UC-MSCs) therapy for patients with DN.

Conditions

Diabetic Nephropathy

Keywords

Diabetic Nephropathy; Safety; Efficiency; Cell Therapy; UC-MSCs

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  The number of Adverse Events associated with UC-MSCs intervention per treatment arm

  From Baseline (0 W) to 48 weeks after treatment

• Adverse Events

  The percentage of Adverse Events associated with UC-MSCs intervention per treatment arm

  From Baseline (0 W) to 48 weeks after treatment

Secondary Outcomes (6)

• Kidney function

  From Baseline (0 W) to 48 weeks after treatment

• Kidney function

  From Baseline (0 W) to 48 weeks after treatment

• Kidney function

  From Baseline (0 W) to 48 weeks after treatment

• Kidney function

  From Baseline (0 W) to 48 weeks after treatment

• SF-36 (The MOS item short from health survey)

  From Baseline (0 W) to 48 weeks after treatment

Study Arms (2)

UC-MSCs treatment group

EXPERIMENTAL

Conventional treatment plus UC-MSCs: Participants will receive conventional treatment plus 3 times of UC-MSCs (1\*10E6 UC-MSCs/kg body weight/100mL intravenously at week 1, week 2，week3).

Drug: UC-MSCs

Placebo control group

PLACEBO COMPARATOR

Conventional treatment plus Placebo: Without UC-MSCs therapy but conventional treatment should be received. Participants will receive conventional treatment plus 3 times of Placebo intravenously at week 1, week 2，week3.

Drug: Placebo

Interventions

UC-MSCs DRUG

3 times of UC-MSCs (1\*10E6 UC-MSCs/kg body weight/100mL saline containing 1% human albumin intravenously at week 1,week 2, week 3).

Also known as: UC-MSCs treatment group

UC-MSCs treatment group

Placebo DRUG

3 times of cell-free stem cell suspension (saline containing 1% human albumin/100mL intravenously at week 1, week 2, week 3).

Also known as: Placebo control group

Placebo control group

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes mellitus, course 5-15 years;
• Age 30-65 years old, no gender limit;
• Accompanied by proteinuria, urine albumin/creatinine ratio (UACR)\>300mg/g or 24h urine protein quantitative\>0.5g/24h;
• eGFR is between 30-60 ml/min/1.732 m2;
• Take RASI-based antihypertensive drugs to control blood pressure and blood pressure meets the following standards: systolic blood pressure \<150mmHg, and diastolic blood pressure \<100mmHg;
• Blood lipids and blood uric acid are controlled at appropriate levels;
• The pathological diagnosis of kidney biopsy is diabetic nephropathy;
• Patients who have good compliance, signed informed consent, and can complete the entire trial treatment and follow-up plan according to the research plan；

You may not qualify if:

• Have a history of primary glomerulonephritis, lupus nephritis, ANCA-related small vasculitis, renal damage, allergic purpura nephritis, hepatitis B-related nephritis;
• Poor blood glucose control: HbA1c ≥9% of patients or 2h postprandial blood glucose\> 22mmol/L;
• Active liver disease or liver function test results are obviously abnormal (ALT or AST ≥ 2 times the upper limit of normal);
• White blood cell count\<3.0×10E9/L, hemoglobin\<80 g/L, platelet count\<100×10E9/L or suffering from other blood system diseases (severe anemia, idiopathic thrombocytopenic purpura, splenomegaly, Patients with coagulopathy, etc.);
• Severe and unstable cardiovascular and cerebrovascular diseases (unstable angina pectoris, coronary artery disease, cerebrovascular disease, transient ischemic attack, congestive heart failure, etc.), acute and uncontrollable disease, still unable to effectively control severe hypertension (blood pressure\> 160/100 mmHg) after treatment or organ transplant patients;
• The dose of antihypertensive drugs and/or hypoglycemic drugs used in the past 3 months has increased significantly than before;
• Uncontrolled infection;
• Suffer from tumor or abnormal level of tumor markers;
• Suffer from blood-borne diseases (for example, HIV, syphilis, hepatitis B and hepatitis C);
• Possibility of pregnancy, preparation for pregnancy or breastfeeding;
• Receive immunosuppressive treatment;
• Have a history of allergies, especially those who are allergic to human albumin;
• Suffer from mental illness, which will affect their voluntariness, decision-making ability and communication ability;
• A history of alcohol abuse or a known history of drug abuse in the last 2 years;
• Participate in another clinical trial within the last 3 months;

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead
• Wuhan Hamilton Biotechnology Co., Ltd: collaborator

Study Sites (1)

Renmin Hospital of Wuhan university

Wuhan, Hubei China, 430075, 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

Huiming Wang, MD

CONTACT

18971563100; rm000301@whu.edu.cn

Yujuan Wang, MD

CONTACT

15926267337; 541785638@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 24, 2020
• Study Start: September 25, 2020
• Primary Completion: September 25, 2021
• Study Completion: December 31, 2021
• Last Updated: September 24, 2020

Record last verified: 2020-09

Locations

CN (1)