Diabetic NephropathyUC-MSCsNCT04562025
Clinical Research of UC-MSCs in the Treatment of Diabetic Nephropathy
A study testing UC-MSCs in people with Diabetic Nephropathy, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- UC-MSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 25 Sep 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renmin Hospital of Wuhan university
Wuhan, Hubei China, 430075
Yujuan Wang, MD, 15926267337, 541785638@qq.com
Huiming Wang, MD
About this study
Official title: Clinical Research of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) in the Treatment of Diabetic Nephropathy
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.
Read the 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.
- Conditions
- Diabetic Nephropathy
- Being tested
- UC-MSCs, Placebo
- Keywords
- Diabetic Nephropathy, Safety, Efficiency, Cell Therapy, UC-MSCs
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UC-MSCsDrug
Also called UC-MSCs treatment group
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).
PlaceboDrug
Also called Placebo control group
3 times of cell-free stem cell suspension (saline containing 1% human albumin/100mL intravenously at week 1, week 2, week 3).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
The number of Adverse Events associated with UC-MSCs intervention per treatment arm
Measured: From Baseline (0 W) to 48 weeks after treatment
Adverse Events
The percentage of Adverse Events associated with UC-MSCs intervention per treatment arm
Measured: From Baseline (0 W) to 48 weeks after treatment
Secondary outcomes (6)
Kidney function
Change in estimated glomerular filtration rate (eGFR) from baseline.
Measured: From Baseline (0 W) to 48 weeks after treatment
Kidney function
Change in 24-hour urinary protein quantification from baseline.
Measured: From Baseline (0 W) to 48 weeks after treatment
Kidney function
Change in urinary albumin/creatinine ratio from baseline
Measured: From Baseline (0 W) to 48 weeks after treatment
Kidney function
The proportion of subjects in both groups who progressed to end-stage renal disease (ESRD) or doubled their serum creatinine.
Measured: From Baseline (0 W) to 48 weeks after treatment
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.
Measured: From Baseline (0 W) to 48 weeks after treatment
Change in HbA1c
Change in Glycosylated Hemoglobin (HbA1c) from baseline.
Measured: From Baseline (0 W) to 48 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start25 Sep 2020 (estimated)
- Primary completion25 Sep 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic NephropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan Hamilton Biotechnology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562025
- Sponsor's protocol ID
- 20200915HMD
- Acronym
- UC-MSCs
- Status last verified
- Sep 2020
- First submitted
- 16 Sep 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) in the Treatment of Diabetic Nephropathy
- ClinicalTrials.gov ID
- NCT04562025
- Acronym / sponsor ID
- UC-MSCs / 20200915HMD
- Conditions
- Diabetic Nephropathy
- Keywords
- Diabetic Nephropathy, Safety, Efficiency, Cell Therapy, UC-MSCs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Collaborators
- Wuhan Hamilton Biotechnology Co., Ltd.
- Study start
- 25 Sep 2020 (estimated)
- Primary completion
- 25 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UC-MSCs treatment group | Experimental | Drug: UC-MSCsConventional 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). |
| Placebo control group | Placebo comparator | Drug: PlaceboConventional 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. |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UC-MSCsAlso: UC-MSCs treatment group3 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). | Drug | UC-MSCs treatment group |
| PlaceboAlso: Placebo control group3 times of cell-free stem cell suspension (saline containing 1% human albumin/100mL intravenously at week 1, week 2, week 3). | Drug | Placebo control group |
Primary outcome
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
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
6 secondary outcomes
Kidney function
Time frame: From Baseline (0 W) to 48 weeks after treatment
Kidney function
Time frame: From Baseline (0 W) to 48 weeks after treatment
Kidney function
Time frame: From Baseline (0 W) to 48 weeks after treatment
Kidney function
Time frame: 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
Change in HbA1c
Time frame: From Baseline (0 W) to 48 weeks after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UC-MSCs in people with Diabetic Nephropathy, run by Renmin Hospital of Wuhan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huiming Wang, MD (18971563100, rm000301@whu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: From Baseline (0 W) to 48 weeks after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2020.