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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis, Knee; Knee Pain
• Intervention / Treatment: Biological: Micro Fragmented Adipose Tissue; Biological: Corticosteroid injection

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: Interventional
• Enrollment (Actual): 40
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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. Micro Fragmented Adipose Tissue: Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection	Biological: Micro Fragmented Adipose Tissue; Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection; Other Names: MFAT
Active Comparator: Conventional therapy; Intra-articular injection of corticosteroid (Triamcinolone 40mg). Corticosteroid injection: Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.	Biological: Corticosteroid injection; Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Pain	Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).	Baseline, 3, 6, 12, and 24 months
Change in Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score - Symptoms	Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms).	Baseline, 3, 6, 12, and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lysholm Score	Patient reported activity outcome measure on a scale of 0-100 (100 is best activity score)	Baseline, 3, 6, 12, and 24 months
Veterans RAND 12 (VR-12) Score - Physical	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).	Baseline, 3, 6, 12, and 24 months
Veterans RAND 12 (VR-12) Score - Mental	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).	Baseline, 3, 6, 12, and 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI Cartilage Scan	Cartilage thickness on MRI using T2-weighted cartilage mapping	12 months

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Eugene Y Roh, MD, Stanford University; Principal Investigator: Jason Dragoo, MD, Stanford University; Principal Investigator: Seth Sherman, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Actual): October 29, 2024
• Study Completion (Actual): October 29, 2024

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: March 10, 2018
• First Posted (Actual): March 16, 2018

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 7, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: osteoarthritis; stem cell; knee pain; injection; adipose derived stem cell; MFAT; Micro Fragmented Adipose Tissue
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenal Cortex Hormones
• Other Study ID Numbers: 41688

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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