MFAT for Knee Osteoarthritis

Overseen By Ma Agnes Ith, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Stanford University

Must be taking: Anti-inflammatories

Must not be taking: Opioids, Anticoagulants

Disqualifiers: Rheumatologic, Inflammatory arthritis, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new treatment, Micro Fragmented Adipose Tissue (MFAT), for knee osteoarthritis. It compares MFAT, which involves injecting a special type of fat tissue into the knee, with the more common corticosteroid injections. The goal is to determine which treatment provides better relief from the pain and stiffness of osteoarthritis. Suitable candidates for this trial include those diagnosed with moderate knee osteoarthritis who have not found success with physical therapy and anti-inflammatory medications. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants the opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on immunomodulatory therapy or anticoagulant treatment, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Micro Fragmented Adipose Tissue (MFAT) is generally safe for people with knee osteoarthritis. One study found that patients who received MFAT injections experienced less pain and improved joint movement over time, with no serious side effects. Another study confirmed the safety and effectiveness of MFAT injections for relieving knee pain, again noting no major safety issues. While some studies found MFAT comparable to other treatments, they still reported it as safe. These findings suggest MFAT is a safe option for treating knee pain from osteoarthritis. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for knee osteoarthritis?

Unlike the standard care for knee osteoarthritis, which often involves corticosteroid injections like Triamcinolone, the Micro Fragmented Adipose Tissue (MFAT) treatment uses a patient's own fat cells to address the condition. This unique approach involves harvesting adipose tissue from the thigh, processing it with minimal manipulation, and then injecting it directly into the knee joint. Researchers are excited about MFAT because it offers a regenerative treatment that might not just alleviate symptoms but potentially repair damaged tissue, providing a longer-lasting solution compared to temporary symptom relief from conventional therapies.

What evidence suggests that this trial's treatments could be effective for knee osteoarthritis?

Research has shown that injections of Micro Fragmented Adipose Tissue (MFAT), one of the treatments studied in this trial, can help ease knee osteoarthritis symptoms. Studies have found that patients often experience less pain and improved movement after receiving MFAT injections. Some patients reported feeling better for up to three years. Evidence also indicates that MFAT can provide noticeable relief at six and twelve months after treatment. However, not all studies agree; some suggest that MFAT is no more effective than a placebo, such as a saline injection. Overall, MFAT has shown promise for many patients in reducing pain and improving knee function. Another treatment arm in this trial involves conventional therapy with corticosteroid injections, serving as an active comparator. ^{5 6 7 8 9}

Who Is on the Research Team?

Eugene Y Roh, MD

Principal Investigator

Stanford University

Jason Dragoo, MD

Principal Investigator

Stanford University

Seth Sherman, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Working understanding of the English language and able to fully understand the procedure

Able to complete online, in-person or phone surveys for the purposes of follow-up

Exclusion Criteria

I have a hormone disorder that is not well-managed.

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

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive intra-articular injection of either Micro Fragmented Adipose Tissue or corticosteroid

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

• Corticosteroid injection
• Micro Fragmented Adipose Tissue

Trial Overview

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.

How Is the Trial Designed?

Group I: MFAT(Micro Fragmented Adipose Tissue) Experimental Treatment 1 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 therapy Active Control 1 Intervention

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

Micro Fragmented Adipose Tissue is already approved in European Union, United States for the following indications:

Approved in European Union as MFAT for:

• Osteoarthritis
• Tendon and joint injuries

Approved in United States as MFAT for:

• Osteoarthritis
• Tendon and joint injuries

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

In a study of 110 knees, a single ultrasound-guided injection of microfragmented adipose tissue (MFAT) significantly reduced pain (VAS score improved from 70 to 30) and enhanced functionality (OKS score improved from 25 to 33.5) in patients with knee osteoarthritis over a 12-month period.

No adverse events were reported during or after the procedure, indicating that MFAT injections are a safe treatment option for knee osteoarthritis, with promising improvements in patient quality of life (EQ-5D score improved from 0.62 to 0.69).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-Centered Outcomes of Microfragmented Adipose Tissue Treatments of Knee Osteoarthritis: An Observational, Intention-to-Treat Study at Twelve Months. Heidari, N., Noorani, A., Slevin, M., et al.[2022]

A single injection of autologous micro-fragmented adipose tissue (MF-AT) significantly improved knee function and reduced pain in patients with knee osteoarthritis over an 18-month period, with the most notable improvements seen at 9-12 months post-injection.

No adverse events were reported during the study, indicating that MF-AT is a safe treatment option; however, the benefits in knee function were not sustained beyond 12 months, and further research is needed to assess long-term cartilage regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-Articular Injection of Autologous Micro-Fragmented Adipose Tissue for the Treatment of Knee Osteoarthritis: A Prospective Interventional Study. Yu, Y., Lu, Q., Li, S., et al.[2023]

In a randomized controlled trial involving 78 patients with knee osteoarthritis, the combination of microfragmented adipose tissue (mFAT) and arthroscopic debridement (AD) significantly improved functional scores compared to AD alone at both 6 months and 24 months follow-up.

The mFAT treatment also resulted in better MRI outcomes, indicating enhanced tissue healing, and was associated with lower T2-mapping scores in knee compartments, suggesting improved cartilage health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Micro-fragmented adipose tissue (mFAT) associated with arthroscopic debridement provides functional improvement in knee osteoarthritis: a randomized controlled trial. Ulivi, M., Meroni, V., Viganò, M., et al.[2023]

In a study of 71 patients with early hip osteoarthritis, injections of autologous micro-fragmented adipose tissue (MFAT) led to significant clinical improvements, with 28 patients not requiring further treatment after an average follow-up of 29 to 41 months.

The Oxford Hip Score improved by an average of 6.9 points post-treatment, indicating that MFAT injections can be an effective option for managing symptoms in early to moderate hip osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is intra-articular injection of autologous micro-fragmented adipose tissue effective in hip osteoarthritis? A three year follow-up. Natali, S., Screpis, D., Romeo, M., et al.[2023]

A single injection of autologous microfragmented adipose tissue (MFAT) significantly improved clinical outcomes, including pain and quality of life, in 75 elderly patients with knee osteoarthritis over a two-year follow-up period.

The best results were observed in patients with early-stage osteoarthritis (KL grade 2), but overall, 88.3% of treatments showed significant functional improvement across all grades of knee OA, suggesting MFAT is a safe and effective alternative treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Two-year clinical outcomes of autologous microfragmented adipose tissue in elderly patients with knee osteoarthritis: a multi-centric, international study. Gobbi, A., Dallo, I., Rogers, C., et al.[2021]

In a study involving 118 patients with knee osteoarthritis, both microfragmented adipose tissue (MF-AT) and platelet-rich plasma (PRP) injections led to significant improvements in knee function and pain relief over 24 months, with no notable differences in outcomes between the two treatments.

While MF-AT and PRP showed similar efficacy, a higher percentage of patients with moderate to severe OA in the MF-AT group achieved clinically meaningful improvements in knee function at 6 months, suggesting a potential advantage for certain patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microfragmented Adipose Tissue Versus Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis: A Prospective Randomized Controlled Trial at 2-Year Follow-up. Zaffagnini, S., Andriolo, L., Boffa, A., et al.[2023]

Citations

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To illustrate, Russo et al. reported improved outcomes up to 3 years after MFAT infiltration for knee OA [25]. In addition, Onorato et al.

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Clinical outcomes were determined at 1, 3, 6, and 12 months follow-up using Knee Injury and Osteoarthritis Outcome Score questionnaire and direct physical ...