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

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ClinicalTrials.gov Identifier: NCT01504464
Recruitment Status : Completed
First Posted : January 5, 2012
Last Update Posted : May 17, 2016
Sponsor:
Information provided by (Responsible Party):
Royan Institute

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Biological: mesenchymal stem cell Biological: Placebo Phase 2

Detailed Description:
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.

Study Type : Interventional
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation the Effects of Intra-articular Injection of Mesenchymal Stem Cells in Patients With Knee Joint Osteoarthritis, Triple Blind Randomized Clinical Trial
Study Start Date : October 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: mesenchymal stem cell
Patients with knee joint osteoarthritis who underwent intra articular mesenchymal stem cell injection.
Biological: mesenchymal stem cell
intra articular injection of mesenchymal stem cell
Other Name: stem cell transplantation

Experimental: placebo
The patients who are in control group and underwent placebo injection.
Biological: Placebo
Patients with knee joint osteoarthritis who underwent intra articular placebo injection




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01504464


Locations
Iran, Islamic Republic of
Royan Institute
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Royan Institute
Investigators
Study Chair: Hamid Gourabi, PhD Head of Royan Institute
Study Director: Nasser Aghdami, MD,PhD Head of Royan Cell therapy Center
Principal Investigator: Mohsen Emadeddin, MD scientist

Responsible Party: Royan Institute
ClinicalTrials.gov Identifier: NCT01504464     History of Changes
Other Study ID Numbers: Royan-Bone-010
First Posted: January 5, 2012    Key Record Dates
Last Update Posted: May 17, 2016
Last Verified: November 2015

Keywords provided by Royan Institute:
knee joint osteoarthritis mesenchymal stem cell

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases