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

NCT04929951 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 59461
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis Shoulder; Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• ASES Shoulder Score

  Patient reported outcome measure that reports shoulder pain and shoulder functionality

  24 Months

Secondary Outcomes (2)

• DASH Outcome Measure

  24 Months

• Veterans RAND 12 (VR-12) score

  24 Months

Study Arms (2)

MFAT (Micro Fragmented Adipose Tissue)

EXPERIMENTAL

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

Conventional Therapy

ACTIVE COMPARATOR

Intra-articular injection of corticosteroid (Triamcinolone 40mg)

Biological: Corticosteroid injection

Interventions

Micro Fragmented Adipose Tissue BIOLOGICAL

Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection

Also known as: MFAT

MFAT (Micro Fragmented Adipose Tissue)

Corticosteroid injection BIOLOGICAL

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

Conventional Therapy

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

RECRUITING

MeSH Terms

Conditions

Shoulder Pain

Interventions

Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: Micro Fragmented Adipose Tissue (MFAT) on Shoulder Osteoarthritis

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 18, 2021
• Study Start: July 28, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 30, 2025

Record last verified: 2025-10

Locations

US (1)