Safety and Efficacy Study of Umbilical Cord-Derived Mesenchymal Stem Cells for Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

Detailed Description
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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)

Official Title
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Clinical Trial of Umbilical Cord-Derived Mesenchymal Stem Cells Transplantation for Rheumatoid Arthritis-Phase I/II

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Biological: Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)
* Drug: Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs)
* Biological: UC-MSC+DMARDS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients fulfilled the classification criteria (2010) for rheumatoid arthritis, man or woman aged from 18 to 70 years old. Patients must be informed of the investigational nature of this study and give written informed consent in accordance with the institutional and hospital guidelines. 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: Any history of ongoing, significant or recurring infections. Any active inflammatory diseases other than RA. Significant cardiac or pulmonary disease. End-stage renal failure. Pregnant or nursing women may not participate due to the possibility of fetal harm or harm to nursing infants from this treatment regimen.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UC-MSCs Treatment<br>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)<br>* -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.<br>|
| Active Comparator: DMARDS<br>Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs). | Drug: Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs)<br>* -Patients will be treated by conventional drugs (DMARDS) for alleviating disease.<br>|
| Active Comparator: UC-MSC+DMARDS<br>Patients will be treated in combination with UC-MSC and DMARDS. | Biological: UC-MSC+DMARDS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| Patient's assessment of pain. |  | 1, 3 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mesenchymal Stem Cells, Rheumatoid Arthritis