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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

Tracking Information
First Submitted Date  ICMJE January 3, 2012
First Posted Date  ICMJE January 5, 2012
Last Update Posted Date May 17, 2016
Study Start Date  ICMJE October 2012
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2012)
  • physical function improvement [ Time Frame: 2weeks ]
    Evaluation the physical function improvement Measured by WOMAC osteoarthritis index after cell injection.
  • change in pain density [ Time Frame: 2 weeks ]
    Evaluation the changing of pain density measured by Visual Analogue Scale after cell injection.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01504464 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2012)
  • joint swelling [ Time Frame: 3months ]
    Evaluation the joint swelling by physical examination after intra articular cell injection.
  • joint erythema [ Time Frame: 3months ]
    Evaluation the joint erythem by physical examination after cell injection
  • deterioration of joint function [ Time Frame: 3months ]
    Evaluation the deterioration of joint function by physical examination after intra articular cell injection.
  • Allergic reactions [ Time Frame: 3months ]
    Evaluation the allergic reactions like skin rash,skin erythema,dyspenea by physical examination after cell injection
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects of Intra-articular Injection of Mesenchymal Stem Cells in Knee Joint Osteoarthritis
Official Title  ICMJE Evaluation the Effects of Intra-articular Injection of Mesenchymal Stem Cells in Patients With Knee Joint Osteoarthritis, Triple Blind Randomized Clinical Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Osteoarthritis
Intervention  ICMJE
  • Biological: mesenchymal stem cell
    intra articular injection of mesenchymal stem cell
    Other Name: stem cell transplantation
  • Biological: Placebo
    Patients with knee joint osteoarthritis who underwent intra articular placebo injection
Study Arms  ICMJE
  • Experimental: mesenchymal stem cell
    Patients with knee joint osteoarthritis who underwent intra articular mesenchymal stem cell injection.
    Intervention: Biological: mesenchymal stem cell
  • Experimental: placebo
    The patients who are in control group and underwent placebo injection.
    Intervention: Biological: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 4, 2012)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01504464
Other Study ID Numbers  ICMJE Royan-Bone-010
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Royan Institute
Study Sponsor  ICMJE Royan Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Royan Institute
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP