NCT01873625

Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Affected Knee Osteoarthritis by Rheumatoid Arthritis

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)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Royan Institute · Other Government
• Sex: All
• Age: 10 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In this study all eligible patients were randomly allocated into two study groups by a permuted block randomization method: group A (control group) received only routine medical therapies and placebo injected into there knees.. Group B received mesenchymal stem cells in addition of routine medical therapy. Patients were categorized according to the following stimulation protocols: To assess the outcomes, after mesenchymal stem cells transplantation at months 1,3,6 and 12 we will examine the patients by: WOMAC questioners, DAS28 scoring , radiographies assessments and biochemical analysis with laboratory tests.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	mesenchymal cell transplantation	Mesenchymal stem cell transplantation in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis.
BIOLOGICAL	placebo

Timeline

• Start date: 2009-10-01
• Primary completion: 2011-03-01
• Completion: 2011-12-01
• First posted: 2013-06-10
• Last updated: 2013-06-10

Locations

1 site across 1 country: Iran