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NCT Number: NCT01873625

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

10 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Royan Institute

Tehran, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Response to routine treatment at last one year.

Treatment and study plan

mesenchymal cell transplantation

Biological

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

Placebo

Biological

Primary outcomes

  1. pain

    Time frame: 1month

    Evaluation the pain reduction after mesenchymal stem cell transplantation that measured by VAS scaling.

  2. physical activity

    Time frame: 1month

    evaluation the improvement of physical activity after mesenchymal stem cell transplantation that measured by WOMAC scoring.

  3. walking distance

    Time frame: 1month

    Evaluation the walking distance after mesenchymal transplantation.

Secondary outcomes

  1. Imaging

    Time frame: 6months

    Evaluation the resurfacing of articular cartilage after mesenchymal transplantation by MRI and radio logic assessment.

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 10, 2013
Registry last updated
Jun 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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