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

Phase 3

Completed

• Conditions: Osteoarthritis, Knee; Knee Pain
• Interventions: Biological: Micro Fragmented Adipose Tissue; Biological: Corticosteroid injection

• Registration Number: NCT03467919
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2018-03-10
• Study First Posted: 2018-03-16
• Study Start: 2018-04-01
• Primary Completion: 2024-10-29
• Study Completion: 2024-10-29
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MFAT(Micro Fragmented Adipose Tissue)	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.
Conventional therapy	Corticosteroid injection	Intra-articular injection of corticosteroid (Triamcinolone 40mg).

Primary Outcome Measures

Name	Time	Method
Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score	24 months	Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms

Secondary Outcome Measures

Name	Time	Method
Veterans RAND 12 (VR-12) score	24 months	Patient reported quality of life outcome measure on a scale of 0-50 with 50 being healthy
Lysholm score	24 months	Patient reported activity outcome measure on a scale of 0-100 (100 is best activity score)

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States