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NCT06121882 · ClinicalTrials.gov registry record · Phase 3
Microfragmented Adipose Tissue Compared to Saline Injection for the Treatment of Knee Osteoarthritis
A Phase 3 study of Osteoarthritis, Knee and Knee Osteoarthritis, sponsored by Lipogems International spa.
- Active
- Registry status
- Phase 3
- Development phase
- 173
- Enrollment target
- 16
- Study locations
NCT06121882: Active Phase 3 study of Osteoarthritis, Knee and Knee Osteoarthritis, sponsored by Lipogems International spa.
NCT06121882 is a Phase 3 study of Osteoarthritis, Knee and Knee Osteoarthritis that is active but no longer recruiting, run by Lipogems International spa. The registered enrollment target is 173 participants, below the 496-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (65% lower). The trial reports 16 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06121882, a Phase 3 study of Osteoarthritis, Knee and Knee Osteoarthritis, is active but no longer recruiting, sponsored by Lipogems International spa.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 173 participants
- Enrollment target
- 16
- Study locations
Study 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.
Primary Outcome
The change from baseline to Month 12 for the Western Ontario and McMaster Universities Osteoarthritis Index pain (WOMAC-A) subscale score (superiority); Scale = 0-100, where 100 is extreme pain
Conditions Studied
Interventions
- DRUG Saline Injection
- DEVICE Microfragmented Adipose Tissue derived using the Lipogems® System
Study Locations (16)
California
- CORE Orthopaedic Medical Center - Encinitas
- Horizon Clinical Research - La Mesa
Florida
- Andrews Research & Ed Foundation - Gulf Breeze
- Hospital for Special Surgery Florida - West Palm Beach
Louisiana
- Fascia Institute and Treatment (FIT) Center - Metairie
- Ochsner Sports Medicine Institute - New Orleans
Texas
- All American Ortho - NextStage Clinical Research - Houston
- Texas Center for Cell Therapy and Research, LLC - San Antonio
Arizona
- Arizona Bone, Joint and Sports Medicine Center LLC - Phoenix
Georgia
- Pinnacle Trials, Inc - Atlanta
Maryland
- Regenerative Orthopedics & Sports Medicine - Rockville
Minnesota
- Mayo Clinic - Rochester - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 173 participants |
| Start Date | 2024-03-15 |
| Est. Completion | 2025-06-23 |
| Phase | Phase 3 |
What the registry record for NCT06121882 still lists
NCT06121882 is an interventional study that assigns participants to a tested intervention. The registered 173 participants enrollment target is mid-sized for trials with a published cap, below the 496-participant average among 112 other Osteoarthritis, Knee trials with a reported enrollment target (65% lower).
The record links to 2 conditions, with Osteoarthritis, Knee appearing as the primary indexed condition, and to 2 interventions - of which Saline Injection is the first listed.
NCT06121882 lists 16 locations in 12 states (California, Florida, Louisiana).
Frequently Asked Questions
What is clinical trial NCT06121882 about?
NCT06121882 is a clinical study titled "Microfragmented Adipose Tissue Compared to Saline Injection for the Treatment of Knee Osteoarthritis". 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.
What is the current status of trial NCT06121882?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 173 participants. The study started on 2024-03-15. Estimated completion is 2025-06-23.
What conditions does trial NCT06121882 study?
This clinical trial studies the following conditions: Osteoarthritis, Knee, Knee Osteoarthritis.
What interventions are being tested in trial NCT06121882?
The interventions under investigation include: Saline Injection (DRUG), Microfragmented Adipose Tissue derived using the Lipogems® System (DEVICE).
Who is sponsoring clinical trial NCT06121882?
This trial is sponsored by Lipogems International spa, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06121882 being conducted?
This trial has 16 study locations across Arizona, California, Florida, Georgia, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06121882's enrollment target sits among peer trials
173 39th of 112 higher than 73 of 112 other Osteoarthritis, Knee trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Osteoarthritis, Knee trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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