What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, such as intra-articular injections of microfragmented adipose tissue, PRP, and MSC therapies, generally have minor and transient side effects. These can include pain, tenderness, swelling, bruising, and bleeding at the injection site. There is also a risk of local infection. While PRP and MSC therapies are considered safe, their efficacy and long-term effects are still under investigation. It is important to discuss these potential side effects and the current evidence with your doctor before proceeding with treatment.

What prior FDA approvals exist?

The FDA has not specifically approved mesenchymal stem cell (MSC) therapies or micro fragmented adipose tissue (MFAT) injections for the treatment of osteoarthritis. While platelet-rich plasma (PRP) is widely used and considered safe for musculoskeletal conditions, including osteoarthritis, it is not explicitly mentioned as FDA-approved in the provided context. Most biologic therapies, including MSCs and PRP, are still under investigation and are often used off-label or within clinical trials to assess their efficacy and safety in treating osteoarthritis.

What other types of research exist?

Promising novel alternatives to intra-articular injection of Micro Fragmented Adipose Tissue for osteoarthritis patients include: 1) Intra-articular injections of alginate-microencapsulated adipose tissue-derived mesenchymal stem cells (ASCs), which have shown potential in animal models for reducing OA progression. 2) Platelet-Rich Plasma (PRP) therapy, which has been studied for its ability to promote tissue repair and reduce inflammation in musculoskeletal injuries. 3) Intra-articular injections of glucocorticoids, which are commonly used for their anti-inflammatory effects, though their long-term efficacy and safety are still debated.

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MFAT for Knee Osteoarthritis

Phase 3

Waitlist Available

Led By Eugene Y Roh, MD

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 35 and 75 years-old

Diagnosis of pre-existing osteoarthritis of the joint by Kellgren-Lawrence Grade 2 or 3

Must not have

Uncontrolled endocrine disorder

Age < 35 or > 75 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial compares the effects of injecting processed fat tissue versus traditional steroid injections in patients with mild to moderate knee osteoarthritis. The fat is taken from the patient's body, slightly processed, and then injected into the knee to help heal and reduce pain and swelling.

Who is the study for?

This trial is for adults aged 35-75 with moderate knee osteoarthritis who've tried physical therapy and anti-inflammatories without success. They must understand English, be able to complete surveys, follow instructions, and walk on their own. Excluded are those outside the age range, severe or minimal arthritis, recent joint injections, high BMI (>35), pregnancy plans, certain medical conditions like uncontrolled diabetes or coagulopathy.

What is being tested?

The study compares two treatments for knee pain due to osteoarthritis: an injection of Micro Fragmented Adipose Tissue (MFAT) versus a standard corticosteroid injection. The goal is to see which treatment better improves clinical outcomes and function in patients.

What are the potential side effects?

Potential side effects may include pain at the injection site, swelling, infection risk increase from injections generally. Corticosteroids can also cause skin discoloration or thinning around the injection area and temporary flare-ups of joint pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 35 and 75 years old.

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I have moderate osteoarthritis according to the Kellgren-Lawrence scale.

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I am able to understand and agree to the study's procedures and risks.

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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 have a hormone disorder that is not well-managed.

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I am younger than 35 or older than 75 years old.

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I have a blood clotting disorder or am on blood thinners.

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I manage chronic pain with medication or experience it in multiple body parts.

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I have osteomyelitis, HIV, hepatitis C, or poorly controlled diabetes (HgA1C >7.0).

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I am scheduled for surgery soon.

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My X-rays show I have little to no osteoarthritis.

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I have had joint replacement or cartilage regeneration surgery.

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I have a rheumatologic condition or inflammatory arthritis.

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I am currently receiving treatment to modify my immune system.

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I have had a stem cell injection in my joint before.

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My BMI is over 35.

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

Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score

Secondary study objectives

Lysholm score

Veterans RAND 12 (VR-12) score

Other study objectives

MRI Cartilage Scan

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 knee 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 knee.

Group II: Conventional therapyActive Control1 Intervention

Intra-articular injection of corticosteroid (Triamcinolone 40mg).

0 / 16Eligibility 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 osteoarthritis (OA) include intra-articular injections of Micro Fragmented Adipose Tissue (MFAT), which promote tissue repair and reduce inflammation through the action of mesenchymal stem cells (MSCs). MSCs can differentiate into various cell types and release paracrine factors that modulate the local environment, reducing inflammation and promoting cartilage repair. Platelet-rich plasma (PRP) is another treatment that provides high concentrations of growth factors to enhance tissue regeneration and reduce inflammation. Nonsteroidal anti-inflammatory drugs (NSAIDs) and corticosteroids are also used to manage pain and inflammation, although they do not promote tissue repair. Understanding these mechanisms is crucial for OA patients as it helps them make informed decisions about treatments that not only alleviate symptoms but also potentially slow disease progression.

The paracrine effect of adipose-derived stem cells inhibits osteoarthritis progression.Mesenchymal stem cell therapy in osteoarthritis: advanced tissue repair or intervention with smouldering synovial activation?