RecruitingPhase 1NCT04929951

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


Sponsor

Stanford University

Enrollment

48 participants

Start Date

Jul 28, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 25 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether injecting micro-fragmented adipose tissue (MFAT) — small pieces of a patient's own fat tissue, processed and injected into the joint — can reduce pain and improve function in people with shoulder osteoarthritis (wear and tear of the shoulder joint). This regenerative medicine approach may provide a non-surgical option for people who have not responded to physical therapy or anti-inflammatory treatments. You may be eligible if: - You are between 25 and 75 years old - You have diagnosed osteoarthritis of the shoulder (glenohumeral joint) - You have tried and failed at least 6 weeks of physical therapy and anti-inflammatory medications - You are able to walk and complete follow-up surveys You may NOT be eligible if: - You have severe (bone-on-bone) or minimal shoulder arthritis on X-ray - You had a prior joint replacement or cartilage regeneration surgery in that shoulder - You had a cortisone, PRP, or hyaluronic acid injection in the past 3 months - You have rheumatoid or inflammatory arthritis - You have uncontrolled diabetes, HIV, hepatitis C, or active infection - Your BMI is over 40 - You are pregnant or planning pregnancy - You have fibromyalgia, chronic opioid use, or chronic multi-site pain - You have a massive rotator cuff tear (2 tendons with retraction) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALMicro Fragmented Adipose Tissue

Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection

BIOLOGICALCorticosteroid injection

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


Locations(1)

Stanford University

Stanford, California, United States

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NCT04929951


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