What side effects are associated with this type of intervention?

Common treatments for osteoarthritis, such as NSAIDs, intraarticular glucocorticoid injections, and investigational treatments like PRP and MFat, have various side effects. NSAIDs can cause gastrointestinal issues, cardiovascular risks, and renal complications. Intraarticular injections may lead to local pain, swelling, and infection risk. PRP and MFat treatments generally show minor and transient adverse effects, including pain, tenderness, and bruising at the injection site.

What prior FDA approvals exist?

The FDA has approved several treatments for osteoarthritis, primarily focusing on pain relief and inflammation reduction. Notably, platelet-rich plasma (PRP) has been used for its anti-inflammatory properties and ability to promote tissue repair, although it is not specifically approved by the FDA for osteoarthritis. Tanezumab, an anti-NGF monoclonal antibody, showed promise in reducing pain but faced safety concerns, leading to halted development. While MFat is being studied for its cushioning and anti-inflammatory effects, there are no direct FDA-approved treatments that match its specific mechanism of action.

What other types of research exist?

Promising alternatives to MFat for osteoarthritis treatment include: 1) Platelet-Rich Plasma (PRP) injections, which have shown potential in reducing pain and improving function in osteoarthritis patients. 2) Adipose-Derived Stem Cells (ADSCs), which are being explored for their regenerative properties and ability to reduce inflammation. 3) Intra-articular injections of mesenchymal stem cells (MSCs), which have demonstrated potential in cartilage repair and reducing osteoarthritis symptoms.

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Fat Cell Injections for Knee Osteoarthritis (ARISE2 Trial)

Phase 3

Recruiting

Research Sponsored by Lipogems International spa

Eligibility Criteria Checklist

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

Must have

Age ≥ 18 years old at the date of screening

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12-month visit

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing an injection of a patient's own processed fat tissue to treat knee pain and improve function in people with moderate knee osteoarthritis. The fat tissue is thought to help by cushioning the joint and possibly aiding in healing. This treatment has been studied for its potential to improve pain and function in patients with knee osteoarthritis.

Who is the study for?

This trial is for adults over 18 with knee osteoarthritis (K/L grade 2/3), who've tried physical therapy and pain meds like NSAIDs or Acetaminophen for at least 3 months without relief. They must be able to attend follow-ups, understand English, and women must not be pregnant or should be postmenopausal or sterilized.

What is being tested?

The study compares the effects of a single injection of Microfragmented Adipose Tissue (MFat) using Lipogems® against a saline solution in reducing pain and improving function in patients with moderate knee osteoarthritis.

What are the potential side effects?

Possible side effects may include discomfort at the injection site, swelling, infection risk, allergic reactions to materials used during treatment, and potential unknown risks associated with MFat.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am 18 years old or older.

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 WOMAC-C (function) Subscale Score

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

Secondary study objectives

Change in Total WOMAC scores

Change in WOMAC-A Pain Sub Score

Change in WOMAC-C Pain 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: Micro Fragmented 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: Saline InjectionActive Control1 Intervention

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

0 / 1Eligibility 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

Common treatments for osteoarthritis (OA) include NSAIDs, corticosteroids, and newer investigational therapies like platelet-rich plasma (PRP) and microfragmented adipose tissue (MFat). NSAIDs work by reducing inflammation and pain through inhibition of cyclooxygenase enzymes. Corticosteroids provide potent anti-inflammatory effects by suppressing various inflammatory pathways. PRP is thought to reduce inflammation and promote tissue repair by delivering high concentrations of growth factors. MFat, similar to PRP, provides cushioning and anti-inflammatory effects by delivering adipose-derived stem cells and other bioactive molecules that can modulate the local inflammatory environment and promote tissue regeneration. These mechanisms are crucial for OA patients as they help manage pain, reduce inflammation, and potentially improve joint function and quality of life.

Patient-Centered Outcomes of Microfragmented Adipose Tissue Treatments of Knee Osteoarthritis: An Observational, Intention-to-Treat Study at Twelve Months.Knee osteoarthritis: pathophysiology and current treatment modalities.