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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03467919
• Other study ID #: 41688
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 1, 2018
• Est. completion date: March 26, 2025

Study information

• Verified date: October 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: March 26, 2025
• Est. primary completion date: January 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Pain
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Biological:
• Micro Fragmented Adipose Tissue
Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection
• Corticosteroid injection
Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MRI Cartilage Scan	Cartilage thickness on MRI using T2-weighted cartilage mapping	12 months
Primary	Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score	Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms	24 months
Secondary	Lysholm score	Patient reported activity outcome measure on a scale of 0-100 (100 is best activity score)	24 months
Secondary	Veterans RAND 12 (VR-12) score	Patient reported quality of life outcome measure on a scale of 0-50 with 50 being healthy	24 months