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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 Knee Osteoarthritis and Osteo Arthritis Knee, sponsored by Lipogems International spa.

Active
Registry status
Phase 3
Development phase
173
Enrollment target
16
Study locations

NCT06121882 is a Phase 3 study of Knee Osteoarthritis and Osteo Arthritis Knee that is active but no longer recruiting, run by Lipogems International spa. The registered enrollment target is 173 participants, below the 303-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (43% lower). The trial reports 16 study locations across 12 states.

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The verdict

NCT06121882, a Phase 3 study of Knee Osteoarthritis and Osteo Arthritis Knee, 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.

Conditions Studied

Knee Osteoarthritis Osteo Arthritis Knee

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

FieldValue
Enrollment Target 173 participants
Start Date 2024-03-15
Est. Completion 2025-06-23
Phase Phase 3

Sponsor

Lipogems International spa

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06121882

The ClinicalTrials.gov registry entry for NCT06121882 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 173 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 303-participant average among 101 other Knee Osteoarthritis trials with a reported enrollment target (43% lower). The listed sponsor is Lipogems International spa, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Knee Osteoarthritis appearing as the primary indexed condition, and to 2 interventions - of which Saline Injection is the first listed.

NCT06121882 reports 16 study locations spanning 12 distinct geographic areas - top geographies include 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: Knee Osteoarthritis, Osteo Arthritis Knee.

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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.