The Effect of Micro Fragmented Adipose Tissue (MFAT) on Shoulder Osteoarthritis
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Osteoarthritis Shoulder, Shoulder Pain
In brief
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.
Key facts
- Study ID
- NCT04929951
- Run by
- Stanford University
- People needed
- 48
- Starts
- 2022-07-28
- Expected to finish
- 2027-12-31
- Last updated by the study team
- 2025-10-30
Who can join
Age: 25 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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
- Concomitant massive(2 tendons with retraction), complete rotator cuff tendon tear
Where it is running
- Stanford University — Stanford, California, United States (enrolling)
Full record on ClinicalTrials.gov
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