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

Primary Purpose

Diabetic Nephropathy

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

UC-MSCs

Placebo

About this trial

This is an interventional treatment trial for Diabetic Nephropathy focused on measuring Diabetic Nephropathy, Safety, Efficiency, Cell Therapy, UC-MSCs

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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；
No exclusion criteria are positive.

Exclusion Criteria:

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;
Poor compliance, unable to complete the entire study；
The researcher diagnosed that the patient is not suitable for this study

Sites / Locations

Renmin Hospital of Wuhan universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

UC-MSCs treatment group

Placebo control group

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

Adverse Events

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

Adverse Events

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

Secondary Outcome Measures

Kidney function

Change in estimated glomerular filtration rate (eGFR) from baseline.

Kidney function

Change in 24-hour urinary protein quantification from baseline.

Kidney function

Change in urinary albumin/creatinine ratio from baseline

Kidney function

The proportion of subjects in both groups who progressed to end-stage renal disease (ESRD) or doubled their serum creatinine.

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

The MOS item short from health survey, SF-36 and changes per visit. As a concise health questionnaire, SF-36 comprehensively summarizes the quality of life of the surveyed from 8 aspects: physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. Higher scores mean a better outcome.

Change in HbA1c

Change in Glycosylated Hemoglobin (HbA1c) from baseline.

Full Information

NCT ID

NCT04562025

First Posted

September 16, 2020

Last Updated

September 22, 2020

Sponsor

Renmin Hospital of Wuhan University

Collaborators

Wuhan Hamilton Biotechnology Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT04562025

Brief Title

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

Acronym

UC-MSCs

Official Title

Clinical Research of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) in the Treatment of Diabetic Nephropathy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 25, 2020 (Anticipated)

Primary Completion Date

September 25, 2021 (Anticipated)

Study Completion Date

December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Renmin Hospital of Wuhan University

Collaborators

Wuhan Hamilton Biotechnology Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Diabetic nephropathy (DN) is one of the most important microvascular complications of diabetes. It is a persistent and refractory disease. There is currently a lack of effective clinical treatments for DN. The basic pathological processes of DN are renal tissue cell damage, apoptosis and continuous increase of inflammatory cytokines induced by early high glucose, which gradually leads to glomerular sclerosis and renal fibrosis. Human umbilical cord mesenchymal stem cells (UC-MSCs), as the "youngest" adult stem cells, have powerful anti-inflammatory functions, stronger differentiation potential, and good safety. They are ideal seed cells for the treatment of DN. At present, studies on a variety of animal models of DN have shown that mesenchymal stem cell transplantation can delay the progression of DN and have a certain repair effect on damaged kidney tissue and renal function. Our previous preclinical study showed that UC-MSCs effectively improved the renal function, inhibited inflammation and fibrosis, and prevented its progression in a rat model of diabetes-induced chronic renal injury. Some autologous or allogeneic mesenchymal stem cells have been carried out abroad treatment of chronic kidney disease caused by various reasons, including clinical trials of DN, phase I/II test results did not show obvious adverse reactions related to stem cell therapy, and can improve the patient's renal function and quality of life to a certain extent. The purpose of this study is to investigate efficiency and safety of UC-MSCs in treating DN patients. This trial will recruit 38 patients. 19 patients received the treatment of conventional treatment + equal volume normal saline containing 1% human albumin (placebo group) were used as control group; conventional treatment + 1*10E6 UC-MSCs/kg body weight (experimental group) for intravenous infusion (once a week, 3 times in total) to treat 19 patients with DN (by unified standard inclusion), and subjects will be followed a total of 48 weeks from time of initial cell treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Nephropathy

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

UC-MSCs treatment group

Arm Type

Experimental

Arm Description

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).

Arm Title

Placebo control group

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

UC-MSCs

Other Intervention Name(s)

UC-MSCs treatment group

Intervention Description

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).

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Placebo control group

Intervention Description

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

Primary Outcome Measure Information:

Title

Adverse Events

Description

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

Time Frame

From Baseline (0 W) to 48 weeks after treatment

Title

Adverse Events

Description

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

Time Frame

From Baseline (0 W) to 48 weeks after treatment

Secondary Outcome Measure Information:

Title

Kidney function

Description

Change in estimated glomerular filtration rate (eGFR) from baseline.

Time Frame

From Baseline (0 W) to 48 weeks after treatment

Title

Kidney function

Description

Change in 24-hour urinary protein quantification from baseline.

Time Frame

From Baseline (0 W) to 48 weeks after treatment

Title

Kidney function

Description

Change in urinary albumin/creatinine ratio from baseline

Time Frame

From Baseline (0 W) to 48 weeks after treatment

Title

Kidney function

Description

The proportion of subjects in both groups who progressed to end-stage renal disease (ESRD) or doubled their serum creatinine.

Time Frame

From Baseline (0 W) to 48 weeks after treatment

Title

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

Description

Time Frame

From Baseline (0 W) to 48 weeks after treatment

Title

Change in HbA1c

Description

Change in Glycosylated Hemoglobin (HbA1c) from baseline.

Time Frame

From Baseline (0 W) to 48 weeks after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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； No exclusion criteria are positive. Exclusion Criteria: 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; Poor compliance, unable to complete the entire study； The researcher diagnosed that the patient is not suitable for this study

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Huiming Wang, MD

Phone

18971563100

rm000301@whu.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Yujuan Wang, MD

Phone

15926267337

541785638@qq.com

Facility Information:

Facility Name

Renmin Hospital of Wuhan university

City

Wuhan

State/Province

Hubei China

ZIP/Postal Code

430075

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Yujuan Wang, MD

Phone

15926267337

541785638@qq.com

First Name & Middle Initial & Last Name & Degree

Huiming Wang, MD

12. IPD Sharing Statement

Learn more about this trial

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

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