RA: Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid Arthritis
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
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)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: UC-MSCs Treatment Patients in UC-MSCs treatment will be infused umbilical cord-derived mesenchymal stem cells intravenously only. |
Biological: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)
-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.
|
| Active Comparator: DMARDS Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs). |
Drug: Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs)
-Patients will be treated by conventional drugs (DMARDS) for alleviating disease.
|
| Active Comparator: UC-MSC+DMARDS Patients will be treated in combination with UC-MSC and DMARDS. |
Biological: UC-MSC+DMARDS
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.
|
Outcome Measures
Primary Outcome Measures
- Safety of MSC treatment. [six months]
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.
Secondary Outcome Measures
- RA Serology [1, 3 and 6 months]
Rheumatoid Factor, C-reactive protein
- Disease Activity Score (DAS 28) Index Mean Change From Baseline [1, 3 and 6 months]
- Patient's assessment of pain. [1, 3 and 6 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
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All patients fulfilled the classification criteria (2010) for rheumatoid arthritis, man or woman aged from 18 to 70 years old.
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Patients must be informed of the investigational nature of this study and give written informed consent in accordance with the institutional and hospital guidelines.
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Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on this trial. Women of child-bearing potential must have a pregnancy test performed within 72 hours prior to initiation of treatment.
Exclusion Criteria:
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Any history of ongoing, significant or recurring infections.
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Any active inflammatory diseases other than RA.
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Significant cardiac or pulmonary disease.
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End-stage renal failure.
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Pregnant or nursing women may not participate due to the possibility of fetal harm or harm to nursing infants from this treatment regimen.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The 323 Hospital of Chinese People's Liberation Army | Xi'an | Shaanxi | China | 710054 |
Sponsors and Collaborators
- Alliancells Bioscience Corporation Limited
Investigators
- Principal Investigator: 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
- Study Director: Liming Wang, MD, The 323 Hospital of Chinese People's Liberation Army
- Principal Investigator: Haijie Ji, MD, Alliancells Biosciences Co., Ltd.
Study Documents (Full-Text)
None provided.More Information
Publications
- 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. Review.
- 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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