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Rheumatoid arthritis is a chronic systemic disease, which is characterized by chronic inflammation in the synovial tissue. Rheumatoid arthritis will eventually result in the destruction of cartilage, bone and ligaments and joint deformity. The underlying hypothesis is that umbilical cord-derived mesenchymal stem cell (UC-MSCs) has anti-inflammatory effects and thus potentially alleviates the progression of rheumatoid arthritis. The study is to explore the safety and efficacy of UC-MSCs transplantation in treatment of rheumatoid arthritis.
This study was supported by the National Natural Science Foundation of China (30872618),The Shanxi Province Social Development Public Relations Project (2012K13-02-35), and The Military Medicine and Public Health Plan (CLZ120GA23)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UC-MSCs Treatment | Experimental | Patients in UC-MSCs treatment will be infused umbilical cord-derived mesenchymal stem cells intravenously only. |
|
| DMARDS | Active Comparator | Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs). |
|
| UC-MSC+DMARDS | Active Comparator | Patients will be treated in combination with UC-MSC and DMARDS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs) | Biological | -The UC-MSCs will be infused intravenously(single dose, 4x10^7 cells).The interval time is 3 months, and the study lasts for 12 months with 4 times infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of MSC treatment. | Adverse Events will be recorded in a patient or clinical investigation subject who administers MSC and will be evaluated a causal relationship with the treatment. | six months |
| Measure | Description | Time Frame |
|---|---|---|
| RA Serology | Rheumatoid Factor, C-reactive protein | 1, 3 and 6 months |
| Disease Activity Score (DAS 28) Index Mean Change From Baseline | 1, 3 and 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingyuan Wu, MD,PhD | Contact | 86-10-63188123 | mingyuan-wu@ouhsc.edu | |
| Haijie Ji, MD | Contact | 86-10-63188853 | jihaijie82@sohu.com |
| Name | Affiliation | Role |
|---|---|---|
| Mingyuan Wu, MD,PhD | Eastern Union Stem Cell & Gene Engineering Co.,Ltd,Alliancells Biosciences Co., Ltd | Principal Investigator |
| Yongjun Liu, MD,PhD | Alliancells Biosciences Co., Ltd | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 323 Hospital of Chinese People's Liberation Army | Recruiting | Xi'an | Shaanxi | 710054 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22138499 | Background | Wang H, Wu M, Liu Y. Are mesenchymal stem cells major sources of safe signals in immune system? Cell Immunol. 2012;272(2):112-6. doi: 10.1016/j.cellimm.2011.10.010. Epub 2011 Oct 29. | |
| 23533920 | Background | Wang L, Ji H, Zhou J, Xie J, Zhong Z, Li M, Bai W, Li N, Zhang Z, Wang X, Zhu D, Liu Y, Wu M. Therapeutic potential of umbilical cord mesenchymal stromal cells transplantation for cerebral palsy: a case report. Case Rep Transplant. 2013;2013:146347. doi: 10.1155/2013/146347. Epub 2013 Mar 3. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 4, 2013 | |
| Reset | Nov 15, 2013 | |
| Release | Apr 13, 2015 |
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| Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) | Drug | -Patients will be treated by conventional drugs (DMARDS) for alleviating disease. |
|
| UC-MSC+DMARDS | Biological | The UC-MSCs will be infused intravenously(single dose, 4x10^7 cells).The interval time is 3 months, and the study lasts for 12 months with 4 times infusion.Meanwhile,patients will be treated by conventionally drugs if the disease is still not alleviated. |
|
| Patient's assessment of pain. | 1, 3 and 6 months |
| Liming Wang, MD | The 323 Hospital of Chinese People's Liberation Army | Study Director |
| Haijie Ji, MD | Alliancells Biosciences Co., Ltd. | Principal Investigator |
| Reset | Apr 28, 2015 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 4, 2013 | Nov 15, 2013 | |||
| Apr 13, 2015 | Apr 28, 2015 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D018501 | Antirheumatic Agents |
| ID | Term |
|---|---|
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
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