MFat vs Corticosteroid Injection for Knee Osteoarthritis

(ARISE Trial)

Recruiting at 20 trial locations

Overseen By Kenneth Bunch, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Lipogems International spa

Must not be taking: Oral corticosteroids, Anti-coagulants

Disqualifiers: Rheumatoid arthritis, Infection, Obesity, 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

Compensation: Varies

Number of Visits: 4

Duration: 1 day

173 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment where a patient's own fat is processed and injected into their knee to help with pain and function in people with moderate knee osteoarthritis. The goal is to see if this method works better by reducing inflammation and promoting healing. This approach has shown promising results in reducing pain and improving function.

Will I have to stop taking my current medications?

Participants must stop using over-the-counter pain medications like Acetaminophen or NSAIDs for 7 days before any follow-up visit and abstain from NSAIDs for 7 days before and 2 weeks after the injection. Prescription pain or anti-inflammatory medications must be stopped for the study duration, except for Tramadol immediately after the procedure.

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

Research shows that using microfragmented adipose tissue (MFAT) injections for knee osteoarthritis can reduce pain and improve quality of life for patients, with some studies indicating benefits lasting up to two years. However, the response rate varies, with about 45% of patients experiencing significant improvement after one year. ^{1 2 3 4 5}

Is the treatment of knee osteoarthritis with corticosteroid injections safe?

Corticosteroid injections for knee osteoarthritis are generally considered safe for repeated use every 3 months for up to 2 years, with common side effects including temporary pain flare, facial flushing, and skin or fat thinning. Systemic complications are rare, but caution is advised with concurrent injections in both knees due to potential increased systemic exposure. ^{6 7 8 9 10}

How does the MFat treatment differ from corticosteroid injections for knee osteoarthritis?

The MFat treatment involves using microfragmented adipose tissue (fat tissue) from the patient's own body, which may offer a regenerative approach to knee osteoarthritis, unlike corticosteroid injections that primarily provide temporary pain relief and reduce inflammation. ^{6 11 12 13 14}

Eligibility Criteria

Adults over 18 with knee osteoarthritis (Grade 2-3) who've had pain despite trying physical therapy and NSAIDs for at least 3 months can join. They must be able to attend follow-ups, read English, and not be pregnant or breastfeeding unless postmenopausal or sterilized. Excluded are those with severe obesity, certain knee deformities, autoimmune diseases needing immunosuppressants, allergies to specific drugs used in the trial, uncontrolled diabetes or blood pressure issues, recent injections or surgeries on the knee.

Inclusion Criteria

You are willing to provide written consent and sign the HIPAA Authorization before taking part in this study.

My knee pain and X-rays show I have osteoarthritis.

I have had knee pain for over 3 months that hasn't improved with basic treatments.

Exclusion Criteria

Respiratory Rate <9 or >20

I have had knee surgery within the last 6 months.

I have knee pain due to a specific bone condition, ligament damage, or a severe meniscus tear.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intra-articular injection of either MFat or corticosteroid at the baseline visit

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain and function using the WOMAC index at 6, 9, and 12-month follow-up visits

12 months

3 visits (in-person)

Treatment Details

Interventions

• Corticosteroid
• Microfragmented Adipose Tissue

Trial Overview The study is testing a single injection treatment for knee osteoarthritis pain and function: one group receives microfragmented adipose tissue (MFat), while another gets a corticosteroid injection. The effectiveness of these treatments will be compared.

Participant Groups

Group I: Microfragmented Adipose Tissue (Mfat) Experimental Treatment 1 Intervention

Injection of Microfragmented Adipose Tissue derived using Lipogems® Kit The cases assigned to this group will be injected intra-articularly with Lipogems®. The patients will undergo lipoaspiration of their own adipose tissue for Mfat then this Mfat will be injected intra-articularly in the knee. It will be administered once at the baseline visit of the study.

Group II: Corticosteroid Injection Active Control 1 Intervention

The cases assigned to this group will be injected intra-articularly in the knee with a corticosteroid. It will be administered once at the baseline visit of the study.

Corticosteroid is already approved in United States, European Union for the following indications:

Approved in United States as Singulair for:

• Asthma
• Exercise-induced bronchoconstriction
• Seasonal allergic rhinitis
• Perennial allergic rhinitis

Approved in European Union as Singulair for:

• Asthma
• Exercise-induced bronchoconstriction
• Seasonal allergic rhinitis
• Perennial allergic rhinitis

Who Is Running the Clinical Trial?

Lipogems International spa

Lead Sponsor

Trials

4

Recruited

540+

Alira Health

Collaborator

Trials

6

Recruited

4,200+

Alira Health

Collaborator

Trials

6

Recruited

4,200+

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 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]

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 intra-articular injection of autologous microfragmented adipose tissue (MFAT) showed a short-term therapeutic response rate of 64% at 3 months and 45% at 12 months in 64 patients with symptomatic knee osteoarthritis, indicating early clinical improvement but a decline in effectiveness over time.

The study found that the presence of bone marrow lesions negatively impacted the therapeutic response rate, suggesting that assessing these lesions could help identify patients who may benefit more from MFAT treatment, potentially increasing the response rate to 70% at 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous Micro-Fragmented Adipose Tissue (MFAT) to Treat Symptomatic Knee Osteoarthritis: Early Outcomes of a Consecutive Case Series. Van Genechten, W., Vuylsteke, K., Martinez, PR., et al.[2021]

In a phase IIa study involving 24 patients with bilateral knee osteoarthritis, the intra-articular injection of triamcinolone acetonide extended release (TA-ER) was well tolerated and showed a lower peak plasma concentration of the drug compared to traditional triamcinolone acetonide crystalline suspension (TAcs).

The study demonstrated that TA-ER resulted in lower systemic exposure to triamcinolone acetonide after bilateral injections, suggesting it may be a safer option for patients needing simultaneous treatment in both knees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized, phase IIa study to assess the systemic exposure of triamcinolone acetonide following injection of extended-release triamcinolone acetonide or traditional triamcinolone acetonide into both knees of patients with bilateral knee osteoarthritis. Kivitz, A., Kwong, L., Shlotzhauer, T., et al.[2022]

In a study involving 60 patients undergoing bilateral total knee arthroplasty, the use of a multimodal cocktail injection with corticosteroids did not show significant differences in pain relief, motion range, or swelling compared to injections without corticosteroids.

The findings suggest that multimodal periarticular injections without corticosteroids can effectively manage postoperative pain and swelling, indicating that corticosteroids like betamethasone may not be necessary for optimal outcomes in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Local Efficacy of Corticosteroids as an Adjuvant for Periarticular Cocktail Injection in Simultaneous Bilateral Total Knee Arthroplasty: A Prospective Randomized Double-Blind Controlled Trial. Peng, H., Wang, W., Lin, J., et al.[2021]

Injectable corticosteroids can cause side effects like lipoatrophy, especially when misused by non-dermatologists, highlighting the need for careful administration.

Serial saline injections have been found to be a safe, quick, and cost-effective treatment for steroid-induced lipoatrophy in children, providing a practical alternative to manage this side effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reversal of steroid-induced lipoatrophy with serial injections of isotonic saline in a child. Daruwalla, SB., Dhurat, RS., Sharma, A., et al.[2021]

A 40 mg intra-articular injection of methylprednisolone acetate (MPA) can provide clinical benefits for knee osteoarthritis symptoms, but careful consideration of factors like pain severity and individual patient circumstances is crucial for effectiveness.

There are significant safety concerns and contraindications associated with MPA injections, especially regarding patients on anticoagulants, highlighting the need for individualized treatment plans and thorough risk-benefit evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic Review of Methylprednisolone Acetate Intra-Articular Injection in the Management of Osteoarthritis of the Knee - Part 2: Clinical and Procedural Considerations. McCrum, C.[2018]

In a study involving 84 patients with symptomatic knee osteoarthritis, a 10-mg dose of triamcinolone acetonide was found to be non-inferior to a 40-mg dose in reducing pain after 12 weeks, indicating that lower doses can be just as effective.

Both the 10-mg and 40-mg doses significantly improved pain and quality of life for patients, suggesting that lower doses may provide a safer option without compromising efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of intra-articular triamcinolone acetonide 10 mg vs. 40 mg in patients with knee osteoarthritis: a non-inferiority, randomized, controlled, double-blind, multicenter study. Utamawatin, K., Phruetthiphat, OA., Apinyankul, R., et al.[2023]

In a study involving 100 patients with knee osteoarthritis, both triamcinolone hexacetonide (TH) and methylprednisolone acetate (MA) injections significantly reduced pain at 4 weeks, with sustained improvements observed up to 24 weeks.

There was no significant difference in efficacy between TH and MA, as both treatments showed similar outcomes in pain relief and functional improvement, indicating that either corticosteroid can be effectively used for managing knee OA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Triamcinolone Hexacetonide versus Methylprednisolone Acetate Intraarticular Injections in Knee Osteoarthritis: A Randomized, Double-blinded, 24-week Study. Lomonte, AB., de Morais, MG., de Carvalho, LO., et al.[2022]

Local corticosteroid injections are generally safe and can effectively manage symptoms in conditions like rheumatoid arthritis and knee osteoarthritis, providing relief for up to three months in some cases.

While these injections can help with acute flare-ups and certain symptoms, they do not significantly prevent joint damage or erosive changes, and their use should complement other treatments like physical therapy and disease-modifying drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-articular corticosteroids. An updated assessment. Gray, RG., Gottlieb, NL.[2006]

References

1. 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]

2. 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]

3. United States 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. [2023]

4. 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]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Autologous Micro-Fragmented Adipose Tissue (MFAT) to Treat Symptomatic Knee Osteoarthritis: Early Outcomes of a Consecutive Case Series. [2021]

6. England pubmed.ncbi.nlm.nih.gov

A randomized, phase IIa study to assess the systemic exposure of triamcinolone acetonide following injection of extended-release triamcinolone acetonide or traditional triamcinolone acetonide into both knees of patients with bilateral knee osteoarthritis. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Local Efficacy of Corticosteroids as an Adjuvant for Periarticular Cocktail Injection in Simultaneous Bilateral Total Knee Arthroplasty: A Prospective Randomized Double-Blind Controlled Trial. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Injectable corticosteroids in modern practice. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Autologous blood injection for treatment of steroid atrophy: A case report. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Reversal of steroid-induced lipoatrophy with serial injections of isotonic saline in a child. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Therapeutic Review of Methylprednisolone Acetate Intra-Articular Injection in the Management of Osteoarthritis of the Knee - Part 2: Clinical and Procedural Considerations. [2018]

12. England pubmed.ncbi.nlm.nih.gov

The efficacy of intra-articular triamcinolone acetonide 10 mg vs. 40 mg in patients with knee osteoarthritis: a non-inferiority, randomized, controlled, double-blind, multicenter study. [2023]

13. Canada pubmed.ncbi.nlm.nih.gov

Efficacy of Triamcinolone Hexacetonide versus Methylprednisolone Acetate Intraarticular Injections in Knee Osteoarthritis: A Randomized, Double-blinded, 24-week Study. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

Intra-articular corticosteroids. An updated assessment. [2006]