MFat vs Corticosteroid Injection for Knee Osteoarthritis
(ARISE Trial)

Recruiting in Palo Alto (17 mi)

+20 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Lipogems International spa

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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.

+8 more

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.

+41 more

Participant Groups

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.

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.

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

🇺🇸 Approved in United States as Singulair for: