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

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04929951
• Other study ID #: 59461
• Status: Recruiting
• Phase: Phase 1
• Start date: July 28, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: September 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis Shoulder
• Shoulder Pain

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
Primary	ASES Shoulder Score	Patient reported outcome measure that reports shoulder pain and shoulder functionality	24 Months
Secondary	DASH Outcome Measure	Patient reported questionnaire that measures physical function and symptoms	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