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The Effects of Stromal Vascular Fraction and Mesenchymal Stem Cells as Intra-articular Injection in Knee Joint Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03164083
Recruitment Status : Not yet recruiting
First Posted : May 23, 2017
Last Update Posted : May 29, 2019
Sponsor:
Information provided by (Responsible Party):
SCARM Institute, Tabriz, Iran

Tracking Information
First Submitted Date  ICMJE May 21, 2017
First Posted Date  ICMJE May 23, 2017
Last Update Posted Date May 29, 2019
Estimated Study Start Date  ICMJE November 10, 2019
Estimated Primary Completion Date August 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2017)
  • physical function improvement [ Time Frame: 2 weeks ]
    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 NCT03164083 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2017)
  • Joint swelling [ Time Frame: 3 months ]
    Evaluation the joint swelling by physical examination after intra articular cell injection
  • Joint erythema [ Time Frame: 3 months ]
    Evaluation the joint erythema by physical examination after cell injection
  • Deterioration of joint function [ Time Frame: 3 months ]
    Evaluation the deterioration of joint function by physical examination after intra articular cell injection
  • Allergic reactions [ Time Frame: 3 months ]
    Evaluation the allergic reactions like skin rash,skin erythema, dyspnea 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 Stromal Vascular Fraction and Mesenchymal Stem Cells as Intra-articular Injection in Knee Joint Osteoarthritis
Official Title  ICMJE Evaluation the Effects of Intra-articular Injection of Mesenchymal Stem Cells and Stromal Vascular Fraction 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 (MSC) and stromal Vascular Fraction (SVF) 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 and stromal Vascular Fraction fram lipoaspirate, 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 *

*   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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 5, 2020
Estimated Primary Completion Date August 21, 2020   (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, Hepatitis C virus (HCV), Hepatitis C virus (HBV)
  • Active neurologic disorder
  • End organ damage
  • Uncontrolled endocrine disorder
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Peyman Keyhanvar, MD, Ph.D 0914 114 6863 drkeyhanvar@gmail.com
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03164083
Other Study ID Numbers  ICMJE SCARM-Osteoarthritis-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party SCARM Institute, Tabriz, Iran
Study Sponsor  ICMJE SCARM Institute, Tabriz, Iran
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Mohammad Nouri, Ph.D Head of SCARM Institute
Study Director: Peyman Keyhanvar, MD, Ph.D Deputy for translational medicine of SCARM institute
Principal Investigator: Seyed Kazem Shakouri, Physiatrist Tabriz University of Medical Sciences
Principal Investigator: Neda keyhanvar, Ph.D SCARM institute
Principal Investigator: Sepideh Bastani, MSc SCARM institute
PRS Account SCARM Institute, Tabriz, Iran
Verification Date June 2018

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