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Micro Fragmented Adipose Tissue (MFat) for 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

ARISE2 Trial Summary

This trial wants to see if injecting a person's own fat cells into their knee can help with pain and movement in people with moderate to severe knee osteoarthritis. Some participants will get the fat

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.Check my eligibility
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.See study design
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.

ARISE2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

ARISE2 Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in WOMAC-C (function) Subscale Score
Change in Western Ontario and McMaster Universities Osteoarthritis Index Pain (WOMAC-A) VA3.1 Score
Secondary outcome measures
Change in Total WOMAC scores
Change in WOMAC-A Pain Sub Score
Change in WOMAC-C Pain Sub Score

ARISE2 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.

Find a Location

Who is running the clinical trial?

Alira HealthUNKNOWN
3 Previous Clinical Trials
237 Total Patients Enrolled
1 Trials studying Osteoarthritis
173 Patients Enrolled for Osteoarthritis
Lipogems International spaLead Sponsor
3 Previous Clinical Trials
371 Total Patients Enrolled
2 Trials studying Osteoarthritis
291 Patients Enrolled for Osteoarthritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for the total number of individuals involved in this medical study?

"Indeed, according to the details provided on clinicaltrials.gov, this research study is actively seeking eligible participants. The trial was initially posted on January 31st, 2024 and had its most recent update on January 16th, 2024. A total of three sites are involved in enrolling a target number of 173 individuals for participation in the study."

Answered by AI

Are new patients currently being accepted for enrollment in this medical study?

"Indeed, the current status of this study on clinicaltrials.gov indicates that patient recruitment is ongoing. The trial was initially posted on January 31st, 2024 and recently updated on January 16th, 2024."

Answered by AI

Has the Food and Drug Administration (FDA) granted approval for the use of Micro Fragmented Adipose Tissue (MFat)?

"Based on the team's assessment at Power, the safety of Micro Fragmented Adipose Tissue (MFat) is rated as 3. This rating is attributed to it being a Phase 3 trial, which indicates that there exists data supporting both its efficacy and multiple rounds of safety information."

Answered by AI

Who else is applying?

What site did they apply to?
Restore Orthopedics and Sports Medicine
Regenerative Orthopedics & Sports Medicine
Arizona Bone, Joint and Sports Medicine Center LLC
Other
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Microfragmented Adipose Tissue Compared to Saline Injection for the Treatment of Knee Osteoarthritis
2024. "Microfragmented Adipose Tissue Compared to Saline Injection for the Treatment of Knee Osteoarthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06121882.
All > Phoenix > Knee Osteoarthritis
~115 spots leftby Apr 2025
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