Trial | NCT01873625  Report issue

Title

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)

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    60
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.
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.
Study Started
Oct 31
2009
Primary Completion
Mar 31
2011
Study Completion
Dec 31
2011
Last Update
Jun 10
2013
Estimate

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

placebo Placebo Comparator

Normal salin injection in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis.

mesencymal stem cell Active Comparator

Mesenchymal stem cell transplantation in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis.

Criteria 

Inclusion Criteria:

Age 18 to 65 years
Body mass index (BMI) ≤30 kg/m2
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.
No Results Posted