Microfragmented Adipose Tissue Compared to Saline Injection for the Treatment of Knee Osteoarthritis
NCT06121882 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 173
Last updated 2025-06-12
Summary
The goal of this clinical trial is to examine the effect of a single autologous, intra-articular injection of MFat versus saline injection for the treatment of pain and function associated with K/L grade 2/3 knee Osteoarthritis.
Participants will receive an injection of MFat or saline.
Conditions
- Knee Osteoarthritis
- Osteo Arthritis Knee
Interventions
- DEVICE
-
Microfragmented Adipose Tissue derived using the Lipogems® System
Intra-articular knee injection of Microfragmented Adipose Tissue (MFat) derived using the Lipogems® System.
- DRUG
-
Saline Injection
Intra-articular knee injection of saline
Sponsors & Collaborators
-
Alira Health
collaborator OTHER -
Lipogems International spa
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-03-15
- Primary Completion
- 2025-06-23
- Completion
- 2025-06-23
- FDA Device
- Yes
Countries
- United States
Study Locations
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