Using fat tissue injections to treat shoulder osteoarthritis
The Effect of Micro Fragmented Adipose Tissue (MFAT) on Shoulder Osteoarthritis
PHASE1 · Stanford University · NCT04929951
This study is testing if injections of processed fat from your own body can help relieve shoulder pain and improve movement better than regular steroid shots for people with mild to moderate shoulder osteoarthritis.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 25 Years to 75 Years |
| Sex | All |
| Sponsor | Stanford University (other) |
| Locations | 1 site (Stanford, California) |
| Trial ID | NCT04929951 on ClinicalTrials.gov |
What this trial studies
This trial is a randomized controlled study comparing the effectiveness of intra-articular injections of Micro Fragmented Adipose Tissue (MFAT) against conventional corticosteroid injections in patients with mild to moderate shoulder osteoarthritis. The MFAT is harvested through lipoaspiration and processed with minimal manipulation in a clinical setting. Participants will be monitored for clinical and functional outcomes to determine the efficacy of MFAT in alleviating shoulder pain and improving joint function.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25 to 75 with mild to moderate osteoarthritis of the shoulder who have not responded to conservative therapies.
Not a fit: Patients with severe osteoarthritis or those who have had recent joint injections or surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective and longer-lasting solution for patients suffering from shoulder osteoarthritis.
How similar studies have performed: While the use of adipose tissue in joint treatments is gaining interest, this specific approach is relatively novel and has not been extensively tested in similar trials.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Stanford, California
- Stanford University — Stanford, California, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteoarthritis Shoulder, Shoulder Pain