- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04562025
Clinical Research of UC-MSCs in the Treatment of Diabetic Nephropathy (UC-MSCs)
Clinical Research of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) in the Treatment of Diabetic Nephropathy
Study Overview
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Huiming Wang, MD
- Phone Number: 18971563100
- Email: rm000301@whu.edu.cn
Study Contact Backup
- Name: Yujuan Wang, MD
- Phone Number: 15926267337
- Email: 541785638@qq.com
Study Locations
-
-
Hubei China
-
Wuhan, Hubei China, China, 430075
- Recruiting
- Renmin Hospital of Wuhan University
-
Contact:
- Yujuan Wang, MD
- Phone Number: 15926267337
- Email: 541785638@qq.com
-
Principal Investigator:
- Huiming Wang, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: UC-MSCs treatment group
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). |
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).
Other Names:
|
PLACEBO_COMPARATOR: Placebo control group
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. |
3 times of cell-free stem cell suspension (saline containing 1% human albumin/100mL intravenously at week 1, week 2, week 3).
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse Events
Time Frame: From Baseline (0 W) to 48 weeks after treatment
|
The number of Adverse Events associated with UC-MSCs intervention per treatment arm
|
From Baseline (0 W) to 48 weeks after treatment
|
Adverse Events
Time Frame: From Baseline (0 W) to 48 weeks after treatment
|
The percentage of Adverse Events associated with UC-MSCs intervention per treatment arm
|
From Baseline (0 W) to 48 weeks after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Kidney function
Time Frame: From Baseline (0 W) to 48 weeks after treatment
|
Change in estimated glomerular filtration rate (eGFR) from baseline.
|
From Baseline (0 W) to 48 weeks after treatment
|
Kidney function
Time Frame: From Baseline (0 W) to 48 weeks after treatment
|
Change in 24-hour urinary protein quantification from baseline.
|
From Baseline (0 W) to 48 weeks after treatment
|
Kidney function
Time Frame: From Baseline (0 W) to 48 weeks after treatment
|
Change in urinary albumin/creatinine ratio from baseline
|
From Baseline (0 W) to 48 weeks after treatment
|
Kidney function
Time Frame: From Baseline (0 W) to 48 weeks after treatment
|
The proportion of subjects in both groups who progressed to end-stage renal disease (ESRD) or doubled their serum creatinine.
|
From Baseline (0 W) to 48 weeks after treatment
|
SF-36 (The MOS item short from health survey)
Time Frame: From Baseline (0 W) to 48 weeks after treatment
|
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.
|
From Baseline (0 W) to 48 weeks after treatment
|
Change in HbA1c
Time Frame: From Baseline (0 W) to 48 weeks after treatment
|
Change in Glycosylated Hemoglobin (HbA1c) from baseline.
|
From Baseline (0 W) to 48 weeks after treatment
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20200915HMD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetic Nephropathy
-
Assiut UniversityUnknownDiabetic Nephropathy Type 2
-
Zheng GuoNot yet recruitingDiabetic Nephropathy Type 2
-
The Third Xiangya Hospital of Central South UniversityCompletedType 2 Diabetic NephropathyChina
-
Centro Universitario de Ciencias de la Salud, MexicoUnknownDiabetic Nephropathy Type 2Mexico
-
Second Affiliated Hospital, School of Medicine,...Second Affiliated Hospital of Wenzhou Medical University; Lishui Country People...RecruitingDiabetic Nephropathy Type 2 | BiomarkerChina
-
University of Sao Paulo General HospitalCompleted
-
Chinese PLA General HospitalCompletedInsulin Pump Therapy in Treating Diabetic Nephropathy
-
Assiut UniversityNot yet recruitingType 2 DM é Diabetic Nephropathy
-
PfizerTerminatedType 2 Diabetic NephropathyUnited States
-
Chang Gung Memorial HospitalUnknown
Clinical Trials on UC-MSCs
-
Wuhan Union Hospital, ChinaWuhan Hamilton Bio-technology Co., Ltd, China.UnknownCOVID-19 | 2019 Novel Coronavirus PneumoniaChina
-
Puren Hospital Affiliated to Wuhan University of...Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Shanghai... and other collaboratorsUnknown
-
Shanghai East HospitalWithdrawn
-
ZhiYong PengTuohua Biological Technology Co. LtdUnknownPneumonia, Viral | Pneumonia, Ventilator-AssociatedChina
-
Puren Hospital Affiliated to Wuhan University of...Wuhan Hamilton Bio-technology Co., LtdWithdrawn
-
Xijing HospitalChanghai Hospital; Southwest Hospital, ChinaUnknownRheumatoid ArthritisChina
-
Beijing 302 HospitalLanZhou University; Chinese PLA General Hospital; Renmin Hospital of Wuhan University and other collaboratorsNot yet recruitingDecompensated CirrhosisChina
-
PT. Prodia Stem Cell IndonesiaRecruitingPolycystic Ovary SyndromeIndonesia
-
The First Affiliated Hospital of Dalian Medical...Unknown
-
Beijing 302 HospitalLanZhou University; Chinese PLA General Hospital; Renmin Hospital of Wuhan University and other collaboratorsRecruitingDecompensated CirrhosisChina