Phase 3
N=40
The Effect of Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis
Osteoarthritis, Knee · Knee Pain
Bottom Line
View on ClinicalTrials.gov: NCT03467919 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Pain — 64.4; 62.5; 63.9; 13.2 score on a scale — p=0.594
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Micro Fragmented Adipose Tissue (Biological); Corticosteroid injection (Biological)
- Age
- Adult, Older Adult · 35+ yrs
- Sex
- All
- Sponsor
- Stanford University
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Pain |
64.4; 62.5; 63.9; 13.2; 8.6; 12.0 | 0.594 |
| PRIMARY Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Symptoms |
49.0; 47.5; 48.6; 4.5; 2.8; 4.1 | 0.847 |
| SECONDARY Lysholm Score |
60.1; 63.3; 60.9; 10.1; 6.3; 9.1 | 0.633 |
| SECONDARY Veterans RAND 12 (VR-12) Score - Physical |
42.9; 42.5; 42.8; 3.4; 4.6; 3.7 | 0.593 |
| SECONDARY Veterans RAND 12 (VR-12) Score - Mental |
55.9; 58.7; 56.6; -1.6; -4.3; -2.3 | 0.480 |
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.
Eligibility 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 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
Data sourced from ClinicalTrials.gov (NCT03467919). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.