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| Name | Class |
|---|---|
| Futian People's Hospital | OTHER |
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The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Rheumatoid Arthritis.
Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into chondrocyte and osteocyte, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of Rheumatoid Arthritis.
To investigate the effects of hUC-MSC treatment for Rheumatoid Arthritis, 20 patients with Rheumatoid Arthritis will be enrolled and receive 4 times of hUC-MSC transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hUC-MSC + DMARDs | Experimental | Patients will be treated in combination with hUC-MSC and DMARDs with a 12 months follow-up. |
|
| DMARDs | Active Comparator | Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) with a 12 months follow-up. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hUC-MSC + DMARDs | Biological | Patients will be treated by conventional drugs (DMARDs) for alleviating disease. Combinated with a single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times. |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of adverse events | According to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI-CTCAE) | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| RA Serology | Rheumatoid Factor, C-reactive protein | 1, 3 ,6 and 12 months |
| Disease Activity Score (DAS 28) Index | 1, 3, 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wei J Zhong | Contact | +86 0755-83980805 | ZhongJW@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhong Z Ye, Professor | Futian People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fourth People's Hospital of Shenzhen | Recruiting | Shenzhen | Guangdong | 518000 | China |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D018501 | Antirheumatic Agents |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018712 | Analgesics, Non-Narcotic |
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|
| DMARDs | Drug | Patients will be treated by conventional drugs (DMARDs) for alleviating disease. |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D000893 | Anti-Inflammatory Agents |
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |