What side effects are associated with this type of intervention?

Corticosteroid injections, used for their anti-inflammatory effects in osteoarthritis, can cause side effects like joint infection, increased pain, and potential cartilage damage with repeated use. Regenerative treatments like microfragmented adipose tissue (MFat) injections are generally safe, with minor and transient side effects such as pain, bleeding, tenderness, swelling, and bruising at the injection site.

What prior FDA approvals exist?

The FDA has approved various treatments for osteoarthritis, including corticosteroids like triamcinolone and methylprednisolone, which are commonly used for their anti-inflammatory properties to provide short-term pain relief. Regenerative therapies, such as platelet-rich plasma (PRP), have been explored but are not yet FDA-approved specifically for osteoarthritis. Other investigational regenerative treatments, like microfragmented adipose tissue (MFat), are still under clinical evaluation and have not received FDA approval for osteoarthritis treatment.

What other types of research exist?

Promising alternatives to MFat and corticosteroids for osteoarthritis treatment include: 1) Matrix-Applied Characterized Autologous Cultured Chondrocytes (MACI), which has shown efficacy in improving knee injury and osteoarthritis outcome scores (KOOS) in clinical trials. 2) Intra-articular injection of sprifermin (rhFGF-18), which has demonstrated an increase in femorotibial cartilage thickness, although its clinical relevance is still under investigation. 3) Type I collagen scaffold combined with infrapatellar fat pad cells for meniscal repair, which has shown potential for meniscal regeneration and inflammation suppression.

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Corticosteroid

MFat vs Corticosteroid Injection for Knee Osteoarthritis (ARISE Trial)

Phase 3

Waitlist Available

Research Sponsored by Lipogems International spa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have both clinical and radiographic findings consistent with osteoarthritis of the knee:

Females of child-bearing potential must have a negative urine pregnancy test performed within 7 days of study enrollment or be postmenopausal (for at least 2 years) or surgically sterilized (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy)

Must not have

Undergone surgical procedures of either knee within 6 months prior to the screening visit.

Knee pain associated with osteochondritis dissecans, ligament damage or displaced meniscus tear.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-month visit

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects from MFat could include pain at the injection site, swelling, and infection risk. Corticosteroids may cause joint infection, temporary flare of joint pain, skin discoloration around the injection site, allergic reactions or weakening of nearby bones.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am not pregnant, have been menopausal for 2+ years, or have had surgery to prevent pregnancy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had knee surgery within the last 6 months.

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

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I am on prescription pain medication for a condition not related to my knee.

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I have not had injections in my knee in the last 6 months.

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I haven't had a severe knee infection or needed antibiotics for any infection in the last 3 months.

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My knee arthritis is either very mild or very severe.

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I have not taken oral steroids in the last 90 days and won't during the study.

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I do not have any active infections, including in my knee or at any tissue harvest site.

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I have an autoimmune disease and take medication to suppress my immune system.

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I have been diagnosed with HIV or viral hepatitis.

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My blood pressure is high despite taking 3 or more medications.

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I cannot have fat tissue taken for medical procedures.

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I have had an organ or bone marrow transplant.

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I have a history of stroke or brain blood flow problems.

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My knee is significantly bent inward or outward.

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

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I have knee problems but only one knee qualifies for the study based on my pain score.

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I don't have conditions like back or hip pain that would affect my knee's evaluation.

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I am expecting to have surgery within the next year.

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I have not had chemotherapy or radiation on the leg or site planned for fat tissue removal.

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My knee injury is untreated and causes symptoms like locking or catching.

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I have a history of heart disease.

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I have asthma symptoms even though I am on medication.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12-month visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12-month visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12-month visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Western Ontario and McMaster Universities Osteoarthritis Index Pain (WOMAC-A) VA3.1 Score

WOMAC-C Subscale Score

Secondary study objectives

Change in Total WOMAC scores

Change in WOMAC-A Pain Sub Score

Change in WOMAC-C Function Sub Score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Microfragmented Adipose Tissue (Mfat)Experimental Treatment1 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 InjectionActive Control1 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.

0 / 25Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Microfragmented adipose tissue (MFat) leverages the regenerative properties of adipose-derived stem cells to promote tissue repair and reduce inflammation in osteoarthritis (OA) joints. These stem cells can differentiate into various cell types, aiding in the regeneration of damaged cartilage and the reduction of inflammatory cytokines. Corticosteroids, on the other hand, are potent anti-inflammatory agents that provide short-term pain relief by reducing inflammation and suppressing the immune response in the affected joint. Understanding these mechanisms is crucial for OA patients as it helps them make informed decisions about their treatment options, balancing the potential for long-term joint repair with MFat against the immediate pain relief offered by corticosteroids.

Pathophysiology and first-line treatment of osteoarthritis.