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The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee 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.
 
ClinicalTrials.gov Identifier: NCT03467919
Recruitment Status : Active, not recruiting
First Posted : March 16, 2018
Last Update Posted : March 21, 2023
Sponsor:
Information provided by (Responsible Party):
Eugene Roh, Stanford University

Study Description
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Brief Summary:
This is a non-surgical trial comparing the clinical and functional outcomes of patients with osteoarthritis treated with Intra-articular injection of Micro Fragmented Adipose Tissue versus conventional therapy of intra-articular injection of corticosteroid.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Knee Pain Biological: Micro Fragmented Adipose Tissue Biological: Corticosteroid injection Phase 3

Detailed Description:

This study will be a randomized controlled trial to compare outcomes between intra-articular injection of Micro Fragmented Adipose Tissue and intra-articular injection of corticosteroid in patients with mild to moderate osteoarthritis of the knee. Micro Fragmented Adipose Tissue will be harvested at the subcutaneous tissue by lipoaspiration. Once fat tissue is obtained, it will be processed with minimal manipulation in the clinic room.

To be considered for participation in this study, patients must have radiographic evidence of mild to moderate osteoarthritis of medial and/or lateral weight-bearing compartments (Kellgren-Lawrence Grade 2 or 3). In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : January 26, 2023
Estimated Study Completion Date : January 26, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
Experimental: MFAT(Micro Fragmented Adipose Tissue)
Intra-articular knee injection of autologous Micro Fragmented Adipose Tissue harvested from the thigh using tumescent lipoaspiration and processing with minimal manipulation. This harvested tissue will then be injected into the patient's knee.
 Biological: Micro Fragmented Adipose Tissue
Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection
Other Name: MFAT
Active Comparator: Conventional therapy
Intra-articular injection of corticosteroid (Triamcinolone 40mg).
 Biological: Corticosteroid injection
Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.


Outcome Measures
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Primary Outcome Measures :
  1. Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score [ Time Frame: 24 months ]
    Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms


Secondary Outcome Measures :
  1. Lysholm score [ Time Frame: 24 months ]
    Patient reported activity outcome measure on a scale of 0-100 (100 is best activity score)

  2. Veterans RAND 12 (VR-12) score [ Time Frame: 24 months ]
    Patient reported quality of life outcome measure on a scale of 0-50 with 50 being healthy


Other Outcome Measures:
  1. MRI Cartilage Scan [ Time Frame: 12 months ]
    Cartilage thickness on MRI using T2-weighted cartilage mapping


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 35 and 75 years-old
  • Diagnosis of pre-existing osteoarthritis of the joint by Kellgren-Lawrence Grade 2 or 3.
  • Working understanding of the English language and able to fully understand the procedure
  • Capable of providing informed consent
  • Able to complete online, in-person or phone surveys for the purposes of follow-up
  • Capable of understanding pre- and post-procedure care instructions
  • Ambulatory at baseline
  • Previous trial and failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy and trial of anti-inflammatory medications if not contraindicated, with or without concomitant bracing and/or injections.

Exclusion Criteria:

  • Age < 35 or > 75 years old
  • Radiographs demonstrating either no, little or severe osteoarthritis (Kellgren-Lawrence Grade 0, 1 )
  • Prior total or partial joint replacement surgery or a surgery involving cartilage regeneration (microfracture, ACI, etc)
  • Previous cortisone and/or Hyaluronic acid intra-articular injection within the last 3 months
  • Co-morbidity with rheumatologic condition, inflammatory arthritis
  • Currently undergoing immunomodulatory therapy
  • Uncontrolled endocrine disorder
  • BMI >35
  • Current diagnosis of osteomyelitis, human immunodeficiency virus (HIV-1, -2) and/or hepatitis C (HCV), infection and poorly controlled diabetes (HgA1C >7.0)
  • Pregnancy or planned pregnancy
  • previous stem cell injection into treatment joint
  • Patient scheduled to undergo any concomitant surgical procedures.
  • Coagulopathy or anticoagulant treatment
  • Chronic pain involving multiple body parts or opioid medication management
Contacts and Locations
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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): NCT03467919


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Eugene Y Roh, MD Stanford University
Principal Investigator: Jason Dragoo, MD Stanford University
Principal Investigator: Seth Sherman, MD Stanford University
More Information
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Responsible Party: Eugene Roh, Director, Sports Ultrasound Medicine, Orthobiologics, Stanford University
ClinicalTrials.gov Identifier: NCT03467919    
Other Study ID Numbers: 41688
First Posted: March 16, 2018    Key Record Dates
Last Update Posted: March 21, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Eugene Roh, Stanford University:
osteoarthritis
stem cell
knee pain
adipose derived stem cell
 injection
MFAT
Micro Fragmented Adipose Tissue
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
 Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases