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

Last updated: January 8, 2025
Sponsor: Stanford University
Overall Status: Active - Recruiting

Phase

1

Condition

Osteoarthritis

Treatment

Corticosteroid injection

Micro Fragmented Adipose Tissue

Clinical Study ID

NCT04929951
59461
  • Ages 25-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age between 25 and 75 years-old

  • Diagnosis of pre-existing osteoarthritis of the glenohumeral joint

  • Working understanding of the English language and able to fully understand theprocedure

  • 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 6weeks of physical therapy and trial of anti-inflammatory medications if notcontraindicated, with or without concomitant bracing and/or injections.

Exclusion

Exclusion Criteria:

  • Age < 25 or > 75 years old

  • Radiographs demonstrating either no, little osteoarthritis, severe(bone on bone)osteoarthritis

  • Prior total or partial joint replacement surgery or surgery involving cartilageregeneration

  • Previous cortisone, PRP or Hyaluronic acid intra-articular injection within the last 3 months

  • Co-morbidity with the rheumatologic condition, inflammatory arthritis

  • Currently undergoing immunomodulatory therapy

  • Uncontrolled endocrine disorder

  • BMI >40 or joint space not visible by ultrasound

  • Current diagnosis of osteomyelitis, human immunodeficiency virus (HIV-1, -2) and/orhepatitis 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 shoulder surgical procedures or othersurgery which may affect outcomes.

  • Coagulopathy or anticoagulant treatment

  • Chronic pain involving multiple body parts or opioid medication management

  • Diagnosis of fibromyalgia

  • Concomitant massive(2 tendons with retraction), complete rotator cuff tendon tear

Study Design

Total Participants: 48
Treatment Group(s): 2
Primary Treatment: Corticosteroid injection
Phase: 1
Study Start date:
July 28, 2022
Estimated Completion Date:
December 31, 2025

Study 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 shoulder. 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 the shoulder (glenohumeral joint). In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.

Connect with a study center

  • Stanford University

    Stanford, California 94305
    United States

    Active - Recruiting

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