Actively Recruiting
The Effect of Micro Fragmented Adipose Tissue (MFAT) on Shoulder Osteoarthritis
Led by Stanford University · Updated on 2025-10-30
48
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating treatments for patients with mild to moderate osteoarthritis of the shoulder. This trial compares the effects of an injection of Micro Fragmented Adipose Tissue, harvested from the thigh, to a conventional corticosteroid injection. The study aims to understand the clinical and functional outcomes of these two injection methods in managing shoulder osteoarthritis. Participants will be randomly assigned to one of two groups. One group will receive an injection of Micro Fragmented Adipose Tissue, which is collected through a minimally invasive lipoaspiration procedure and processed with minimal handling before injection into the shoulder joint. The other group will receive an injection of corticosteroid called Triamcinolone 40mg. This randomized controlled trial also includes sham harvesting for the corticosteroid group to maintain blinding. During the study, participants will be assessed over 24 months using tools like the ASES Shoulder Score, DASH Outcome Measure, and Veterans RAND 12 score to evaluate shoulder function and quality of life. Follow-up will include surveys done online, in person, or by phone. The trial is designed to monitor participants' progress and safety throughout this period, with a total participation age range between 25 and 75 years.
CONDITIONS
Brief Title
The Effect of Micro Fragmented Adipose Tissue (MFAT) on Shoulder Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Age less than 25 or greater than 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 greater than 40 or joint space not visible by ultrasound
- Current diagnosis of osteomyelitis, HIV-1 or HIV-2, hepatitis C, infection, and poorly controlled diabetes (HgA1C greater than 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment session with follow-up assessments up to 24 months
Participants receive either an injection of Micro Fragmented Adipose Tissue harvested from their thigh or an intra-articular corticosteroid injection in the shoulder.
1 treatment visit and multiple follow-up visits over 24 months
Trial Site Locations
Total: 1 location
1
Stanford University
Stanford, California, United States, 94305
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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