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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03164083
Recruitment Status : Withdrawn (not approved by sponsor)
First Posted : May 23, 2017
Last Update Posted : March 18, 2020
Information provided by (Responsible Party):
SCARM Institute, Tabriz, Iran

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

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 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 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 and Stromal Vascular Fraction Patients With Knee Joint Osteoarthritis, Triple Blind Randomized Clinical Trial
Estimated Study Start Date : November 10, 2019
Estimated Primary Completion Date : August 21, 2020
Estimated Study Completion Date : December 5, 2020

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: 2 weeks ]
    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: 3 months ]
    Evaluation the joint swelling by physical examination after intra articular cell injection

  2. Joint erythema [ Time Frame: 3 months ]
    Evaluation the joint erythema by physical examination after cell injection

  3. Deterioration of joint function [ Time Frame: 3 months ]
    Evaluation the deterioration of joint function by physical examination after intra articular cell injection

  4. Allergic reactions [ Time Frame: 3 months ]
    Evaluation the allergic reactions like skin rash,skin erythema, dyspnea by physical examination after cell injection

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT03164083

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Iran, Islamic Republic of
SCARM Institute
Tabriz, Iran, Islamic Republic of
Sponsors and Collaborators
SCARM Institute, Tabriz, Iran
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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
Publications of Results:
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Responsible Party: SCARM Institute, Tabriz, Iran Identifier: NCT03164083    
Other Study ID Numbers: SCARM-Osteoarthritis-001
First Posted: May 23, 2017    Key Record Dates
Last Update Posted: March 18, 2020
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SCARM Institute, Tabriz, Iran:
Joint Diseases
Musculoskeletal Diseases
Additional relevant MeSH terms:
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Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases