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| Name | Class |
|---|---|
| The First People's Hospital of Yunnan | OTHER |
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This study would further evaluate the safety and efficacy of human amniotic mesenchymal stem cell (hA-MSC) for the treatment of lupus nephritis (LN).
Eleven patients with WHO class III, IV or V LN were given hA-MSC (Peripheral intravenous infusion, dose 1×106/kg cells, once every month for three times). At the same time, five patients with LN who were not given hA-MSC as the blank control group. All patients did not received intravenous corticosteroids pulse therapy, but the use of oral corticosteroids and intravenous cyclophosphamide, or oral mycophenolate mofetil, tacrolimus , leflunomide were allowed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| human amniotic mesenchymal stem cell treatment group | Experimental |
| |
| blank control group | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| human amniotic mesenchymal stem cell | Drug | human amniotic mesenchymal stem cell (hA-MSC) for the treatment of lupus nephritis patients with WHO class III, IV or V LN were given hA-MSC (Peripheral intravenous infusion, dose 1×106/kg cells, once every month for three times). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Events | The patient's discomfort and clinical symptoms during the study were recorded, as well as the related laboratory test indicators and physical examination abnormalities of the subjects during the study. Describe the association with Amniotic mesenchymal stem cell therapy and calculate the incidence of treatment-related acute and chronic adverse events. | 60 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in 24h urine protein quantification before and after treatment; | 24-hour urinary protein quantification from baseline to 60 weeks of treatment. | 60 weeks |
| Changes in eGFR before and after treatment; |
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Enrollment criteria:
Exclusion criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35412950 | Derived | Naeem A, Gupta N, Naeem U, Khan MJ, Elrayess MA, Cui W, Albanese C. A comparison of isolation and culture protocols for human amniotic mesenchymal stem cells. Cell Cycle. 2022 Aug;21(15):1543-1556. doi: 10.1080/15384101.2022.2060641. Epub 2022 Apr 12. |
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| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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changes in estimated glomerular filtration rate (eGFR) from baseline to 60 weeks of treatment.
| 60 weeks |
| Changes in SLEDAI score before and after treatment; | changes in SLEDAI score from baseline to 60 weeks of treatment. SLEDAI score: 0~4 points basically no activity;5-9 minutes light activity;10-14 minutes of moderate activity;≥15 minutes of severe activity. | 60 weeks |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |