48 Participants Needed

MFAT vs Corticosteroids for Shoulder Osteoarthritis

EY
Overseen ByEugene Y Roh, MD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

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 MFAT safe for treating osteoarthritis?

Research suggests that micro-fragmented adipose tissue (MFAT) injections are generally safe for treating osteoarthritis, with studies showing improvements in pain and function without significant safety concerns.12345

How does the MFAT treatment differ from other treatments for shoulder osteoarthritis?

MFAT treatment is unique because it uses a patient's own fat tissue, which is processed and injected into the joint to reduce pain and improve function, potentially offering a long-term alternative to surgery by promoting tissue regeneration and reducing inflammation.12346

What data supports the effectiveness of this treatment for shoulder osteoarthritis?

Research shows that using micro-fragmented adipose tissue (MFAT) injections can significantly improve pain and function in patients with shoulder osteoarthritis, with benefits lasting up to a year. Similar studies on knee osteoarthritis also report reduced pain and improved joint function, suggesting MFAT is a promising treatment for joint issues.12356

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.
See 5 more

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.
See 13 more

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?
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)

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

Find a Clinic Near You

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 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.
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 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.
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 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.
An observational study evaluating the efficacy of microfragmented adipose tissue in the treatment of osteoarthritis.Fan, F., Grant, RA., Whitehead, JP., et al.[2023]

Citations

Clinical use of autologous micro-fragmented fat progressively restores pain and function in shoulder osteoarthritis. [2021]
Is intra-articular injection of autologous micro-fragmented adipose tissue effective in hip osteoarthritis? A three year follow-up. [2023]
An observational study evaluating the efficacy of microfragmented adipose tissue in the treatment of osteoarthritis. [2023]
Two-year clinical outcomes of autologous microfragmented adipose tissue in elderly patients with knee osteoarthritis: a multi-centric, international study. [2021]
Patient-Centered Outcomes of Microfragmented Adipose Tissue Treatments of Knee Osteoarthritis: An Observational, Intention-to-Treat Study at Twelve Months. [2022]
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. [2022]
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