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The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03467919
Recruitment Status : Recruiting
First Posted : March 16, 2018
Last Update Posted : May 1, 2020
Sponsor:
Information provided by (Responsible Party):
eyroh, Stanford University

Tracking Information
First Submitted Date  ICMJE December 20, 2017
First Posted Date  ICMJE March 16, 2018
Last Update Posted Date May 1, 2020
Actual Study Start Date  ICMJE April 1, 2018
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2018)
  • Lysholm score [ Time Frame: 24 months ]
    Patient reported activity outcome measure on a scale of 0-100 (100 is best activity score)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 29, 2020)
MRI Cartilage Scan [ Time Frame: 12 months ]
Cartilage thickness on MRI using T2-weighted cartilage mapping
Original Other Pre-specified Outcome Measures
 (submitted: March 10, 2018)
MRI Cartilage Scan [ Time Frame: 24 months ]
Cartilage thickness on MRI using T2-weighted cartilage mapping
 
Descriptive Information
Brief Title  ICMJE The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
Official Title  ICMJE The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Osteoarthritis, Knee
  • Knee Pain
Intervention  ICMJE
  • Procedure: Micro Fragmented Adipose Tissue
    Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection
  • Procedure: Corticosteroid injection
    Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Micro Fragmented Adipose Tissue
  • Active Comparator: Conventional therapy
    Intra-articular injection of corticosteroid (Triamcinolone 40mg).
    Intervention: Procedure: Corticosteroid injection
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 20, 2019)
40
Original Estimated Enrollment  ICMJE
 (submitted: March 10, 2018)
45
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ma Agnes Ith, MD (650) 721-7600 mith@stanford.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03467919
Other Study ID Numbers  ICMJE 41688
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party eyroh, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eugene Y Roh, MD Stanford University
Principal Investigator: Jason Dragoo, MD Stanford University
Principal Investigator: Seth Sherman, MD Stanford University
PRS Account Stanford University
Verification Date April 2020

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