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Completed

NCT Number: NCT03467919

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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Knee Pain Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Micro Fragmented Adipose Tissue

Biological

Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection

Other names: MFAT

Corticosteroid injection

Biological

Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.

Primary outcomes

  1. Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Pain

    Time frame: Baseline, 3, 6, 12, and 24 months

    Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).

  2. Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Symptoms

    Time frame: Baseline, 3, 6, 12, and 24 months

    Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).

Secondary outcomes

  1. Lysholm Score

    Time frame: Baseline, 3, 6, 12, and 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 - Physical

    Time frame: Baseline, 3, 6, 12, and 24 months

    Patient reported quality of life outcome measure. VR-12 scores are reported as T-scores, which are standardized to have a mean of 50 and a standard deviation of 10 in the US population. Higher scores indicate better physical outcomes. Because this is a normalized range, there is theoretically no strict upper or lower bound. Most people will fall somewhere between 20-70 (+/- 3 SD).

  3. Veterans RAND 12 (VR-12) Score - Mental

    Time frame: Baseline, 3, 6, 12, and 24 months

    Patient reported quality of life outcome measure. VR-12 scores are reported as T-scores, which are standardized to have a mean of 50 and a standard deviation of 10 in the US population. Higher scores indicate better mental outcomes. Because this is a normalized range, there is theoretically no strict upper or lower bound. Most people will fall somewhere between 20-70 (+/- 3 SD).

Other outcomes

  1. MRI Cartilage Scan

    Time frame: 12 months

    Cartilage thickness on MRI using T2-weighted cartilage mapping

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Mar 16, 2018
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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