Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Rheumatoid Arthritis.

Detailed Description
-----------------
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.

Official Title
-----------------
Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Biological: hUC-MSC + DMARDs
* Drug: DMARDs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-80 Rheumatoid Arthritis patient; Patients must consent in writing to participate in the study by signing and dating an informed consent document; Patients must have a diagnosis of Rheumatoid Arthritis according to the 2010 ACR/EULAR criteria for at least 12 weeks duration; Stage I and II according to X-ray. Exclusion Criteria: History of neurological disease, head injury or psychiatric disorder; Pregnant women; Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition; Progressive apoplexy; With malignant tumors; Patients who had participated in other clinical trials within three months prior to this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hUC-MSC + DMARDs<br>Patients will be treated in combination with hUC-MSC and DMARDs with a 12 months follow-up. | Biological: hUC-MSC + DMARDs<br>* 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.<br>* Other names: Human Umbilical Cord-Mesenchymal Stem Cells;|
| Active Comparator: DMARDs<br>Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) with a 12 months follow-up. | Drug: DMARDs<br>* Patients will be treated by conventional drugs (DMARDs) for alleviating disease.<br>* Other names: Methotrexate;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of adverse events | According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Human Umbilical Cord Mesenchymal Stem Cell, Mesenchymal Stem Cell, Rheumatoid Arthritis