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

NCT ID: NCT03467919

Last Updated: 2026-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2024-10-29

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.

Conditions

Osteoarthritis, Knee; Knee Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Micro Fragmented Adipose Tissue

Intervention Type: BIOLOGICAL

Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection

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.

Group Type: ACTIVE_COMPARATOR

Corticosteroid injection

Intervention Type: BIOLOGICAL

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

Interventions

Micro Fragmented Adipose Tissue

Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection

Intervention Type: BIOLOGICAL

Corticosteroid injection

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

Intervention Type: BIOLOGICAL

Other Intervention Names

MFAT

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 < 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Eugene Roh

Director, Sports Ultrasound Medicine, Orthobiologics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eugene Y Roh, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Jason Dragoo, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Seth Sherman, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

41688

Identifier Type: -

Identifier Source: org_study_id