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

NCT ID: NCT04929951

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-28
• Study Completion Date: 2027-12-31

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 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.

Conditions

Osteoarthritis Shoulder; Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Micro Fragmented Adipose Tissue

Intervention Type: BIOLOGICAL

Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection

Conventional Therapy

Intra-articular injection of corticosteroid (Triamcinolone 40mg)

Group Type: ACTIVE_COMPARATOR

Corticosteroid injection

Intervention Type: BIOLOGICAL

Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.

Interventions

Micro Fragmented Adipose Tissue

Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection

Intervention Type: BIOLOGICAL

Corticosteroid injection

Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.

Intervention Type: BIOLOGICAL

Other Intervention Names

MFAT

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Eugene Roh

Clinical Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Stanford University

Stanford, California, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Jessica Nguyen, BS

Role: primary

jessn16@stanford.edu

(650)723-0003

Elizabeth(Telsie) Jameiro, MD

Role: backup

ejameiro@stanford.edu

(650)723-0003

Other Identifiers

59461

Identifier Type: -

Identifier Source: org_study_id