Transplantation of Autologous Bone Marrow Derived Stem Cells in Patients With 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 ultimately results in the destruction of cartilage, bone and ligaments and joint deformity. The underlying hypothesis is that autologous bone marrow-derived mesenchymal and specific populations of stem cells has anti-inflammatory and regenerative effects and thus potentially alleviates the progression of rheumatoid arthritis. The study is to explore the safety and efficacy of BM-SC transplantation in treatment of rheumatoid arthritis.

Detailed Description
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Rheumatoid arthritis (RA) is a chronic autoimmune disorder that primarily affects joints. It typically results in swollen and painful joints. Pain and stiffness often worsen after rest. Most frequently, the wrist and hands are involved, with the same joints typically involved on both sides of the body. RA affects between 0.5-1% of adults in the developed world with between 5-50 per 100,000 people newly developing the disease each year. Onset is most frequent during middle age and women are affected 2.5 times as frequently as men. The goal of treatment is to reduce pain, decrease inflammation, and improve a person's overall functioning and quality of life. Herein, the investigators study the safety and efficacy of the immunomodulatory effects of bone marrow-derived stem cells administered intravenously and the regenerative and repair potential of bone marrow-derived stem cells transplanted into the joints of patients with RA.

Official Title
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Transplantation of Autologous Purified Bone Marrow Derived Specific Populations of Stem Cells and Mesenchymal Stem Cells in Patients With Rheumatoid Arthritis

Conditions
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RheumatoId Arthritis, Osteoarthritis, Knee, Osteoarthritis, Hip

Intervention / Treatment
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* Biological: Stem Cell Transplantation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 17-75 years old The presence of osteoarthritis based on MRI and American Rheumatism Association criteria since 6 months before treatment. Exclusion Criteria: Subjects with addition major health condition/disease diagnoses Subjects that are pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 17 Years
Maximum Age: 75 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem Cells<br>Autologous bone marrow-derived stem cell transplantation. | Biological: Stem Cell Transplantation<br>* Intravenous administration of autologous bone marrow derived stem cells for immunomodulation. Transplantation of autologous bone marrow derived stem cells in joints.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Pain Reduction measured by VAS scaling | measured by VAS scaling | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the Physical Activity measure by WOMAC scoring |  | 1 month | 
| Evaluation the resurfacing of articular cartilage by MRI |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stem cells, Rheumatoid arthritis