NCT06121882

Microfragmented Adipose Tissue Compared to Saline Injection for the Treatment of Knee Osteoarthritis

A Randomized, Multi-center, Double Blind, Parallel Study to Examine the Effect of Lipogems Processed Microfragmented Adipose Tissue in Comparison to Saline for the Treatment of Knee Osteoarthritis

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Lipogems International spa · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study will investigate The Lipogems System in a clinical study to examine the effect of adipose tissue processed using The Lipogems System in comparison to saline for the treatment of knee osteoarthritis. This study will be randomized and double-blinded. The subjects will be randomized at a 2:1 ratio (investigational to control) and will enroll 173 patients at up to 20 sites in the United States.

Conditions

• Knee Osteoarthritis
• Osteo Arthritis Knee

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-03-15
• Primary completion: 2025-06-23
• Completion: 2025-06-23
• First posted: 2023-11-08
• Last updated: 2025-06-12

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated device study