MFAT vs Corticosteroids for Shoulder Osteoarthritis

Overseen By Eugene Y Roh, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Stanford University

Must not be taking: Opioids, Anticoagulants, Immunomodulators, others

Disqualifiers: Rheumatologic condition, Inflammatory arthritis, HIV, others

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

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

48 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of two treatments for shoulder osteoarthritis, a condition where the shoulder joint deteriorates and causes pain. One group will receive a new treatment called Micro Fragmented Adipose Tissue, which uses small pieces of fat from the patient's own body. The other group will receive a standard treatment with a corticosteroid injection. The trial aims to determine which treatment provides better pain relief and improves shoulder function. Individuals with shoulder osteoarthritis who have not found relief from physical therapy or anti-inflammatory medications might be suitable candidates. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are currently undergoing immunomodulatory therapy or taking 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) injections are generally safe. In a study on shoulder pain, patients who received MFAT reported few side effects and experienced less pain with improved movement. Another study on knee osteoarthritis found similar results, with patients experiencing pain relief and improved function, along with few negative effects.

This trial is in an early stage, focusing mainly on safety. Early trials typically start with small doses to assess how well participants tolerate the treatment. Researchers closely monitor for any side effects. If MFAT had serious safety issues, it likely wouldn't be tested at this stage.

In summary, current research suggests MFAT is safe with few problems reported. However, like any clinical trial, this study is still exploring its complete safety profile. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Micro Fragmented Adipose Tissue (MFAT) is unique because it uses a patient's own fat tissue, harvested from the thigh, to create an injection for shoulder osteoarthritis. This approach might provide a more natural and regenerative alternative compared to standard treatments like corticosteroids, which mainly reduce inflammation. Researchers are excited about MFAT because it could potentially promote healing and tissue regeneration directly in the affected joint, offering a novel mechanism of action that goes beyond just symptom relief. Additionally, the use of minimally manipulated autologous tissue may reduce the risk of adverse reactions, making it a promising option for those seeking long-term benefits.

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

Research has shown that injections of Micro Fragmented Adipose Tissue (MFAT), one of the treatments studied in this trial, can help treat osteoarthritis. Studies have found that MFAT reduces pain and improves joint function. For example, individuals with shoulder osteoarthritis experienced less pain and improved shoulder mobility after receiving MFAT treatment. Additionally, MFAT has been linked to better joint health by promoting cartilage regrowth. These findings suggest that MFAT could be a promising option for those suffering from painful joints due to osteoarthritis. Participants in this trial will receive either MFAT or a conventional corticosteroid injection to compare their effectiveness. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 25 and 75 years old.

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

I've tried physical therapy and anti-inflammatory meds for over 6 weeks without success.

Exclusion Criteria

I am scheduled for shoulder surgery or another surgery that could affect my study results.

Pregnancy or planned pregnancy

I have been diagnosed with fibromyalgia.

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 follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Corticosteroid injection
• Micro Fragmented Adipose Tissue

Trial Overview 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.

How Is the Trial Designed?

Group I: MFAT (Micro Fragmented Adipose Tissue) Experimental Treatment 1 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 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 involving 63 joints, autologous microfragmented adipose tissue injections significantly improved patient-reported outcomes for knee and shoulder osteoarthritis from 2 to 52 weeks, indicating its efficacy as a treatment.

The effectiveness of this treatment appears to be inversely related to body mass index (BMI), suggesting that higher obesity levels may reduce the treatment's benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An observational study evaluating the efficacy of microfragmented adipose tissue in the treatment of osteoarthritis. Fan, F., Grant, RA., Whitehead, JP., 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]

In a study of 25 patients with shoulder osteoarthritis, the injection of nondigested micro-fragmented adipose tissue (MFat™) led to significant improvements in pain and function over a year, as measured by the visual analog scale and disabilities of the arm, shoulder, and hand.

The results suggest that MFat™ therapy is an effective long-term treatment option for joint pain and inflammation in shoulder osteoarthritis, potentially serving as an alternative to surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical use of autologous micro-fragmented fat progressively restores pain and function in shoulder osteoarthritis. Vinet-Jones, H., F Darr, K.[2021]

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 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 pilot study involving 10 wheelchair users with chronic shoulder pain due to rotator cuff disease, ultrasound-guided injections of micro-fragmented adipose tissue (MFAT) showed no significant adverse events, indicating a good safety profile.

Significant reductions in pain scores were observed at 6 and 12 months post-injection, with 77.8% of participants experiencing clinically meaningful improvements, suggesting that MFAT injections may be an effective treatment option for refractory shoulder pain in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study to evaluate micro-fragmented adipose tissue injection under ultrasound guidance for the treatment of refractory rotator cuff disease in wheelchair users with spinal cord injury. Hogaboom, N., Malanga, G., Cherian, C., et al.[2022]

Citations

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Efficacy and Long-Term Outcomes of Intra-Articular ... ADMSC treatment exerted favorable effects on the clinical outcomes of patients with GOA, providing pain relief and improving shoulder function.

3. tandfonline.com tandfonline.com/doi/abs/10.2217/rme-2022-0110

An Observational Study Evaluating the Efficacy of ... This study shows MFAT injections are safe and effective in treating painful joints. Tweetable abstract. A microfragmented adipose tissue injection to the ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S074980632400639X

Microfragmented Adipose Tissue Injection Reduced Pain ... In this study, MFAT demonstrated a clinically significant improvement in outcome scores compared with a saline control (C) group.

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Micro-fragmented adipose tissue—An ... In joint injuries, MFAT injections provide pain relief and functional improvements while promoting cartilage regeneration. In plastic surgery, ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04929951

The Effect of Micro Fragmented Adipose Tissue (MFAT) on ... This study will be a randomized controlled trial to compare outcomes between intra-articular injection of Micro Fragmented Adipose Tissue and intra-articular ...

7. mltj.online mltj.online/outcomes-after-micronized-fat-adipose-transfer-for-glenohumeral-joint-arthritis-and-rotator-cuff-pathology-a-case-series-of-18-shoulders/

Outcomes after Micronized Fat Adipose Transfer for ... This study aimed to evaluate the safety and clinical outcomes of patients treated with micro-fragmented adipose tissue for shoulder pain secondary to ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10762526/

Mid-term outcomes of microfragmented adipose tissue plus ... Mid-term outcomes of microfragmented adipose tissue plus arthroscopic surgery for knee osteoarthritis: A randomized, active-control, multicenter clinical trial.

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Micro-Fragmented Adipose Tissue Demonstrates ... micro-fragmented aspirated tissue injection therapy for the treatment of symptomatic knee osteoarthritis is effective and improves pain and functional outcomes.