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| ID | Type | Description | Link |
|---|---|---|---|
| S2025-166-02 | Other Identifier | Ethics Committee of Chinese PLA General Hospital |
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This trial is to evaluate the efficacy and safety of umbilical cord-derived mesenchymal stromal cells (Amimestrocel ) in study subjects with progressive diabetic kidney disease (DKD), to investigate whether Amimestrocel can improve renal function or proteinuria of DKD patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Amimestrocel | Experimental | patients receive standard treatment and Amimestrocel is administered via Intravenous infusion on day 1, 14, 28, and week 8, 12, 16, 20, 24. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amimestrocel | Drug | In the first month (day 1, 14, 28): 1×10E6 cells per kilogram. From the 8th to the 24th week (week 8, 12, 16, 20, 24): 1.5×10E6 cells per kilogram. |
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| Measure | Description | Time Frame |
|---|---|---|
| Urine protein | Urine protein will be measured on 24h urine samples | Change from baseline at 24 weeks |
| estimated Glomerular Filtration Rate(eGFR) | GFR will be estimated by CKD-EPI | Change from baseline at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| fasting blood glucose | fasting blood glucose | Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion |
| HbA1c | Glycated Hemoglobin A1c |
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Inclusion Criteria: -
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| xiangmei chen | Contact | +86 010 66935462 | liping.8@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Hospital | Recruiting | Beijing | Beijing Municipality | 100010 | China |
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| ID | Term |
|---|---|
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion |
| Urinary Albumin/Creatinine Ratio(UACR) | UACR will be measured on spot morning urine samples | Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion |
| proportion of outcome ( ≥50% declined in eGFR,reached end stage renal disease (ESRD), or occured Renal replacement) | proportion of outcome ( ≥50% declined in eGFR,reached End Stage Renal Disease (ESRD), or occured Renal Replacement Therapy) | proportion of study participants within outcome at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion |
| proportion of major adverse cardiac events(MACE) and all-cause mortality | proportion of major adverse cardiac events(MACE:CV death, non-fatal CV event(myocardial infarction, stroke, hospitalization for HF)) and all-cause mortality | proportion of study participants within outcome at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion |
| Mechanism exploration | Explore the mechanism through blood tests(Serum/plasma concentrations (pg/ml) of biomarkers of inflammation. Proportion/total number of circulating T cells, B cells, NK cells, etc ). | Change from baseline at 4,12,24 weeks and 12 months |
| changes in retinal imaging | Macular vascular density by Optical Coherence Tomography Angiography (OCTA), and analyze the percentage of changes in retinal imaging of patients compared to the baseline . | Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion |
| Changes in peripheral nerve injury | Examine through electromyography, to evaluate the percentage of changes in peripheral nerve injury of patients compared with the baseline. | Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion |
| Changes in symptoms | The traditional Chinese Medicine(TCM)Syndrome Rating Scale will be used to score TCM symptoms,to evaluate the percentage of changes in the symptoms of patients compared with the baseline. | Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion |
| Changes in the quality of life scale | The Diabetes Quality-of-Life Measure (DQOL) will be used to score quality of life at each visit, to evaluate the percentage of the change in the DQOL of patients compared to the baseline | Change from baseline at 24 weeks and then every 6 months to study completion, up to 24 months after cell infusion |
| Adverse Event and Serious Adverse Event(SAE) | within 28 weeks after received Amimestrocel |
| secondary malignant disease | Number of Participants with secondary malignant disease | within 24 months after received Amimestrocel |
| China-Japan Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100029 | China |
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| Capital Medical University Affiliated Beijing Friendship Hospital | Recruiting | Beijing | Beijing Municipality | 100050 | China |
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| Xuanwu Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | 100053 | China |
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| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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| Beijing Tsinghua Changgung Hospital, Medical Center, Tsinghua University | Not yet recruiting | Beijing | Beijing Municipality | 102218 | China |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |