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| Name | Class |
|---|---|
| Chinese PLA General Hospital | OTHER |
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The study was a 48-week multicenter, randomized, double-blind, placebo-controlled trial that included 8 weeks of pre-screening and lifestyle education, 32 weeks of treatment, and 16 weeks of follow-up.To observe the efficacy and safety of umbilical cord mesenchymal stem cell infusion in Chinese patients with type 2 diabetic nephropathy who received traditional hypoglycemic therapy.
The study was a 48-week multicenter, randomized, double-blind, placebo-controlled trial that included 8 weeks of pre-screening and lifestyle education, 32 weeks of treatment, and 16 weeks of follow-up.We plan to recruit 54 subjects,which were divided into experimental group and control group. The volunteers of the experimental group will be given peripheral intravenously a dose of 1.5*10^6/kg human umbilical cord mesenchymal stem cell (HUC-MSC) at 0,8,16,24,32 week. The control group will be given the same dose of saline. Then centralization visit was conducted every 8 weeks until the 48th week.The primary end points include estimated glomerular filtration rate and urinary albumin creatinine ratio(UACR). The secondary end points include HbA1C,plasma insulin and C-peptide, and insulin dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| experimental group | Experimental | The volunteers of the experimental group will be given peripheral intravenously a dose of 1.5*10^6/kg human umbilical cord mesenchymal stem cells at 0,8,16,24,32 week. |
|
| control group | Placebo Comparator | The control group will be given the same dose of saline containing human albumin. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human umbilical cord mesenchymal stem cells | Biological | human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group |
|
| Measure | Description | Time Frame |
|---|---|---|
| UACR | urinary albumin creatinine ratio | 48weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | HbA1c | 48weeks after treatment |
| insulin/C peptide | serum level of insulin/C peptide | 48weeks after treatment |
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Inclusion Criteria (in brief):
Exclusion Criteria (in brief):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Congrong Wang, MD | Contact | +86-021-38804518 | wcr601@163.com | |
| Zhongming Liu, MD | Contact | +86-021-38804518 | liu.zhongmin@tongji.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhongming Liu, MD | Shanghai East Hospital, Shanghai Tongji University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai East Hospital | Recruiting | Shanghai | Shanghai Municipality | 200124 | China |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| saline | Other | Saline solution containing human serum albumin will be infused to the control group |
|
| insulin dosage | insulin dosage | 48weeks after treatment |
| eGFR | estimated glomerular filtration rate | 48weeks after treatment |
| D017670 |
| Sodium Compounds |