MFAT vs Corticosteroids for Shoulder Osteoarthritis

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Stanford University

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

Disqualifiers: Rheumatologic condition, Inflammatory arthritis, HIV, others

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 2 3 5 6}

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. ^{1 2 4 5 6}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Corticosteroid injection (Corticosteroid)
• Micro Fragmented Adipose Tissue (Other)

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.

Participant Groups

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)

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Dr. Richard A. Miller

Stanford University

Chief Executive Officer since 2023

Stanford University, MD

Dr. Robert Schott

Stanford University

Chief Medical Officer since 2021

University of Michigan, MD

Findings from Research

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Clinical use of autologous micro-fragmented fat progressively restores pain and function in shoulder osteoarthritis. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Is intra-articular injection of autologous micro-fragmented adipose tissue effective in hip osteoarthritis? A three year follow-up. [2023]

3. England pubmed.ncbi.nlm.nih.gov

An observational study evaluating the efficacy of microfragmented adipose tissue in the treatment of osteoarthritis. [2023]

4. Germany 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. [2021]

5. United States 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. [2022]

6. England 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. [2022]