Rheumatoid Arthritis Clinical Trial
Official title:
Resurfacing Articular Cartilage With Mesenchymal Stem Cells Transplantation in Patients With Knee Joint Osteoarthritis Affected by Rheumatoid Arthritis: Randomized Triple Blind Clinical Trial Phase II/III (ACRCT)
Verified date | August 2009 |
Source | Royan Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | Iran: Ethics CommitteeIran: Ministry of Health |
Study type | Interventional |
Osteoarthritis of the knee is one of the most common causes of disability among elderly. Arthritis rheumatoid is an autoimmune disease which causes multi articular arthritis, such as knee osteoarthritis. As the disease progresses the cartilage become frustrated, surrounding bone react to become thicker and inflammation occurs in subchondral bone seen in T2-weighted MRI as increase in signal density. Patients are treated initially by pain management. In patients who don't response to first line treatment invasive treatment like total knee replacement is done. The investigators designed this clinical study with the aim of evaluating therapeutic effects of intra-articular injection of bone marrow mesenchymal stem cells (BM-MSCs) in 60 patients with knee osteoarthritis.
Status | Completed |
Enrollment | 60 |
Est. completion date | December 2011 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 10 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Age 18 to 65 years 2. Body mass index (BMI) =30 kg/m2 3. The presence of osteoarthritis based on MRI and American Rheumatism Association criteria since 6 months before invitation Exclusion Criteria: 1. Response to routine treatment at last one year. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Royan Institute | Tehran |
Lead Sponsor | Collaborator |
---|---|
Royan Institute |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | pain | Evaluation the pain reduction after mesenchymal stem cell transplantation that measured by VAS scaling. | 1month | Yes |
Primary | physical activity | evaluation the improvement of physical activity after mesenchymal stem cell transplantation that measured by WOMAC scoring. | 1month | Yes |
Primary | walking distance | Evaluation the walking distance after mesenchymal transplantation. | 1month | Yes |
Secondary | Imaging | Evaluation the resurfacing of articular cartilage after mesenchymal transplantation by MRI and radio logic assessment. | 6months | Yes |
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