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

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.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Pain; Osteoarthritis Shoulder
• Intervention / Treatment: Biological: Micro Fragmented Adipose Tissue; Biological: Corticosteroid injection

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Recruiting
      • Stanford University
      • Principal Investigator: Eugene Y Roh, MD
      • Principal Investigator: Geoffrey D Abrams, MD
      • Contact: Shannon Schultz, BA; Phone Number: 650-723-2897; Email: sks01@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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 < 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 cartilage regeneration
• 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/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 shoulder surgical procedures or other surgery 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MFAT (Micro Fragmented Adipose Tissue); Intra-articular shoulder 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 shoulder.	Biological: Micro Fragmented Adipose Tissue; Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection; Other Names: MFAT
Active Comparator: Conventional Therapy; Intra-articular injection of corticosteroid (Triamcinolone 40mg)	Biological: Corticosteroid injection; Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASES Shoulder Score	Patient reported outcome measure that reports shoulder pain and shoulder functionality	24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DASH Outcome Measure	Patient reported questionnaire that measures physical function and symptoms	24 Months
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

Collaborators and Investigators

• Sponsor: Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 4, 2021
• First Submitted That Met QC Criteria: June 10, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Arthralgia; Osteoarthritis; Shoulder Pain
• Other Study ID Numbers: 59461

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No