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

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: placebo; Biological: mesenchymal cell transplantation

• Registration Number: NCT01873625
• Lead Sponsor: Royan Institute

Brief 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.

Study Timeline

• Status Verified: 2009-08
• Study Start: 2009-10
• Primary Completion: 2011-03
• Study Completion: 2011-12
• Study First Submitted: 2013-06-05
• Study First Submitted QC: 2013-06-07
• Last Update Submitted: 2013-06-07
• Study First Posted: 2013-06-10
• Last Update Posted: 2013-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	Normal salin injection in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis.
mesencymal stem cell	mesenchymal cell transplantation	Mesenchymal stem cell transplantation in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis.

Primary Outcome Measures

Name	Time	Method
pain	1month	Evaluation the pain reduction after mesenchymal stem cell transplantation that measured by VAS scaling.
physical activity	1month	evaluation the improvement of physical activity after mesenchymal stem cell transplantation that measured by WOMAC scoring.
walking distance	1month	Evaluation the walking distance after mesenchymal transplantation.

Secondary Outcome Measures

Name	Time	Method
Imaging	6months	Evaluation the resurfacing of articular cartilage after mesenchymal transplantation by MRI and radio logic assessment.

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of