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| Name | Class |
|---|---|
| Changhai Hospital | OTHER |
| Southwest Hospital, China | OTHER |
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This study evaluates the safety and therapeutic effects of single-dose human umbilical cord blood mesenchymal stem cells (UC-MSCs) on the adult patients with moderate/severe Rheumatoid Arthritis accompany with anemia or/and Interstitial pulmonary disease. Half of participants will receive UC-MSCs and keep the present medication,while the other half will receive a placebo and keep the present medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UC-MSCs treatment | Experimental | the participants will receive the single-dose UC-MSCs (1×10^6 cells/kg ) in combined with the present treatment. |
|
| no UC-MSCs treatment | No Intervention | the participants will receive the placebo in combined with the present treatment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UC-MSCs | Biological | The UC-MSCs will be administrated by intravenous injection at the dose of 1×10^6 cells/kg. |
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| Measure | Description | Time Frame |
|---|---|---|
| Improvement rate of blood routine hemoglobin (HGB) compared to baseline. | The HGB increases by 10g compared to the baseline is considered improvement. | 24 weeks |
| Improvement rate of forced vital capacity (FVC) and/or carbon monoxide diffusing capacity (DLCO) compared to baseline. | FVC increases by 0.5% and DLCO increases by 10% compared to baseline are considered improvement. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The remission rates of American College of Rheumatology (ACR) 20, ACR 50 and ACR 70. | The patients achieves 20%, 50%, or 70% remission according to American College of Rheumatology (ACR) criteria. | 12 weeks and 24 weeks |
| White blood cell count and platelet count improved compared to the baseline. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ping Zhu, Doctor | Contact | 86-29-84773951 | zhuping@fmmu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D000740 | Anemia |
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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White blood cell count increases to the 3.5×10^9/L and platelet count increases to 80×10^ 9. |
| 12 weeks and 24 weeks |
| Improvement rate of blood routine hemoglobin (HGB) compared to baseline. | The HGB increases by 10 g compared to the baseline is considered improvement. | 12 weeks |
| Improvement rate of forced vital capacity (FVC) and/or carbon monoxide | FVC increases by 0.5% and DLCO increases by 10% compared to baseline | 12 weeks |
| Image improvement of lung on high resolution CT. | The area change of image of lung. | 24 weeks |
| Improvement of 6-minute walking distance compared to baseline. | 12 weeks and 24 weeks |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |