What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Common treatments for shoulder osteoarthritis, such as intra-articular injections of platelet-rich plasma (PRP) and corticosteroids, have known side effects. PRP injections can cause minor and transient risks such as pain, bleeding, tenderness, swelling, and bruising at the injection site. Corticosteroid injections may lead to side effects like joint infection, post-injection flare (temporary worsening of symptoms), and potential weakening of tendons. While micro fragmented adipose tissue (MFAT) injections are being studied for their potential to promote tissue repair and reduce inflammation, the side effects are not well-documented but may include similar risks associated with other intra-articular injections.

What prior FDA approvals exist?

As of now, there are no specific FDA approvals for the treatment of shoulder osteoarthritis using intra-articular injections of Micro Fragmented Adipose Tissue (MFAT) or mesenchymal stem cells (MSCs). Most FDA-approved treatments for shoulder osteoarthritis focus on pain management and include nonsteroidal anti-inflammatory drugs (NSAIDs), corticosteroid injections, and physical therapy. Biologic therapies like MSCs are still largely experimental and are typically administered within clinical trials rather than as standard treatments.

What other types of research exist?

Promising alternatives to intra-articular injection of micro fragmented adipose tissue for shoulder osteoarthritis include: 1) Platelet-Rich Plasma (PRP) injections, which deliver cytokines and growth factors to promote healing and reduce inflammation. 2) Mesenchymal Stem Cells (MSCs) from sources other than adipose tissue, such as bone marrow-derived MSCs, which have shown potential in tissue repair and anti-inflammatory effects. 3) Autologous Tenocytes, which involve engrafting cells directly into the tissue to promote repair. These alternatives have been studied for their efficacy in musculoskeletal injuries and may offer similar benefits to MFAT.

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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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)

0 / 15Eligibility criteria met

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?