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MFAT vs Corticosteroids for Shoulder Osteoarthritis

Phase 1
Recruiting
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age between 25 and 75 years-old
Diagnosis of pre-existing osteoarthritis of the glenohumeral joint
Must not have
Patient scheduled to undergo any concomitant shoulder surgical procedures or other surgery which may affect outcomes.
Diagnosis of fibromyalgia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial compares two treatments for shoulder osteoarthritis: injections of processed fat tissue versus traditional injections. The fat is taken from the patient's own body, processed slightly, and then injected into the shoulder. The goal is to see if this new method can better reduce pain and improve joint function compared to traditional methods.

Who is the study for?
This trial is for adults aged 25-75 with shoulder osteoarthritis who've tried physical therapy and anti-inflammatory meds without success. They must understand English, be able to follow care instructions, complete surveys, and not have had joint replacement or certain injections recently. Excluded are those with severe arthritis, rotator cuff tears, rheumatologic conditions, uncontrolled endocrine disorders, infections like HIV/HCV or poorly controlled diabetes.
What is being tested?
The study compares the effects of Micro Fragmented Adipose Tissue (MFAT) injection versus corticosteroid injection in treating shoulder osteoarthritis. It aims to assess which treatment better improves clinical outcomes and function without surgery.
What are the potential side effects?
Possible side effects may include pain at the injection site, swelling, infection risk increase due to the procedure itself. Corticosteroids can also cause joint deterioration with repeated use and temporary increases in blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 25 and 75 years old.
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I have been diagnosed with shoulder arthritis.
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I can walk by myself without help.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for shoulder surgery or another surgery that could affect my study results.
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I have been diagnosed with fibromyalgia.
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I have inflammatory arthritis.
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I have a hormone disorder that is not well-managed.
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I manage chronic pain with medication or experience it in multiple body parts.
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I do not have osteomyelitis, HIV, hepatitis C, or poorly controlled diabetes (HgA1C <= 7.0).
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I have had joint replacement or cartilage regeneration surgery.
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I have a blood clotting disorder or am on blood thinners.
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I have had a stem cell injection in my joint before.
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I have a severe shoulder injury involving complete tears in two tendons.
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I am currently receiving treatment to modify my immune system.
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I am younger than 25 or older than 75.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ASES Shoulder Score
Secondary study objectives
DASH Outcome Measure
Veterans RAND 12 (VR-12) score

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: MFAT (Micro Fragmented Adipose Tissue)Experimental Treatment1 Intervention
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.
Group II: Conventional TherapyActive Control1 Intervention
Intra-articular injection of corticosteroid (Triamcinolone 40mg)

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for shoulder osteoarthritis include nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroid injections, which primarily reduce inflammation and provide pain relief. Intra-articular injections of Micro Fragmented Adipose Tissue (MFAT) are being studied for their potential to promote tissue repair and reduce inflammation through the action of mesenchymal stem cells (MSCs). MSCs can differentiate into various cell types and release cytokines that modulate the inflammatory response, potentially improving joint function and slowing disease progression. This is particularly important for shoulder OA patients as it offers a potential treatment that not only alleviates symptoms but also addresses underlying tissue damage and inflammation.
Mesenchymal stem cell therapy in osteoarthritis: advanced tissue repair or intervention with smouldering synovial activation?

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,461 Previous Clinical Trials
17,494,826 Total Patients Enrolled

Media Library

Micro Fragmented Adipose Tissue (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04929951 — Phase 1
Shoulder Osteoarthritis Research Study Groups: MFAT (Micro Fragmented Adipose Tissue), Conventional Therapy
Shoulder Osteoarthritis Clinical Trial 2023: Micro Fragmented Adipose Tissue Highlights & Side Effects. Trial Name: NCT04929951 — Phase 1
Micro Fragmented Adipose Tissue (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04929951 — Phase 1
Shoulder Osteoarthritis Patient Testimony for trial: Trial Name: NCT04929951 — Phase 1
~16 spots leftby Dec 2025