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

NCT03467919 | Completed Phase 3 Results FDA Drug

• 1 other identifier: 41688
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Pain; Osteoarthritis, Knee

Keywords

osteoarthritis; stem cell; knee pain; adipose derived stem cell; injection; MFAT; Micro Fragmented Adipose Tissue

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Lysholm Score

  Baseline, 3, 6, 12, and 24 months

• Veterans RAND 12 (VR-12) Score - Physical

  Baseline, 3, 6, 12, and 24 months

• Veterans RAND 12 (VR-12) Score - Mental

  Baseline, 3, 6, 12, and 24 months

Other Outcomes (1)

• MRI Cartilage Scan

  12 months

Study Arms (2)

MFAT(Micro Fragmented Adipose Tissue)

EXPERIMENTAL

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

Conventional therapy

ACTIVE COMPARATOR

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

Interventions

Micro Fragmented Adipose Tissue BIOLOGICAL

Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection

Also known as: MFAT

MFAT(Micro Fragmented Adipose Tissue)

Corticosteroid injection BIOLOGICAL

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

Conventional therapy

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Clinical Research Cooridnator
• Organization: Stanford Unviersity

jessn16@stanford.edu

6507230003

Study Officials

• Eugene Y Roh, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Jason Dragoo, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Seth Sherman, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Sports Ultrasound Medicine, Orthobiologics

Model Details: Micro Fragmented Adipose Tissue (MFAT) on Knee Osteoarthritis

Study Record Dates

• First Submitted: December 20, 2017
• First Posted: March 16, 2018
• Study Start: April 1, 2018
• Primary Completion: October 29, 2024
• Study Completion: October 29, 2024
• Last Updated: January 26, 2026
• Results First Posted: January 26, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)