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NCT Number: NCT01504464

The Effects of Intra-articular Injection of Mesenchymal Stem Cells in Knee Joint Osteoarthritis

Osteoarthritis of the knee is one of the most common causes of disability among elderly. 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 patients with severe knee osteoarthritis.

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Royan Institute

Tehran, Iran

About this study

This is single center, randomized, triple blind phase II clinical study. Patients will be divided into two groups of case and control. All subjects will undergo bone marrow aspiration. Mesenchymal stem cells will be isolated from bone marrow, cultured and transplanted back to the knee joint. Patients of case group will receive cell injection 1 and 4 months after bone marrow aspiration. Placebo will be administered in this group 6 months after the first injection. Patients of control group will receive placebo 1 and 4 months after bone marrow aspiration. They all receive cell injection 6 months after first placebo injection. Follow up visit will occur at 2 and 6 weeks, and 3 and 6 months after the first injection. Radiological exams will be performed before and 6 months after the first injection by MRI. Clinical quantitative assessment will measure joint function by the WOMAC index and pain by the visual analogue scale.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Osteoarthritis diagnosed by MRI

Exclusion criteria

  • Pregnancy or lactating
  • Positive tests for HIV, HCV, HBV
  • Active neurologic disorder
  • End organ damage
  • Uncontrolled endocrine disorder

Treatment and study plan

Mesenchymal stem cell

Biological

intra articular injection of mesenchymal stem cell

Other names: stem cell transplantation

Placebo

Biological

Patients with knee joint osteoarthritis who underwent intra articular placebo injection

Primary outcomes

  1. physical function improvement

    Time frame: 2weeks

    Evaluation the physical function improvement Measured by WOMAC osteoarthritis index after cell injection.

  2. change in pain density

    Time frame: 2 weeks

    Evaluation the changing of pain density measured by Visual Analogue Scale after cell injection.

Secondary outcomes

  1. joint swelling

    Time frame: 3months

    Evaluation the joint swelling by physical examination after intra articular cell injection.

  2. joint erythema

    Time frame: 3months

    Evaluation the joint erythem by physical examination after cell injection

  3. deterioration of joint function

    Time frame: 3months

    Evaluation the deterioration of joint function by physical examination after intra articular cell injection.

  4. Allergic reactions

    Time frame: 3months

    Evaluation the allergic reactions like skin rash,skin erythema,dyspenea by physical examination after cell injection

Sponsors and collaborators

Lead sponsor

Royan Institute

Other Gov

Registry information

Official study title

Evaluation the Effects of Intra-articular Injection of Mesenchymal Stem Cells in Patients With Knee Joint Osteoarthritis, Triple Blind Randomized Clinical Trial

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jan 5, 2012
Registry last updated
May 17, 2016

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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