← Back to Search

Regenerative Medicine

Ultrasound-Guided Lipogems Injections for Torn Meniscus

Phase 2
Recruiting
Research Sponsored by Kessler Foundation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Physical examination findings consistent with a meniscal tear: joint line tenderness; localized pain with flexion; and other provocative tests such as McMurray's and Thessaly test
18-45 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will evaluate a new treatment for meniscal tears, which are a common knee injury for active-duty military personnel. The new treatment, called micro-fragmented adipose tissue, will be compared to the current standard of care. The goal is to show that micro-fragmented adipose tissue is a more effective treatment for reducing pain and restoring activity levels.

Who is the study for?
This trial is for active-duty military and civilians aged 18-45 with a meniscal tear, experiencing symptoms like joint pain or clicking, who have not improved after at least 4 weeks of conservative treatment. Candidates should be considered suitable for knee surgery by an orthopedic surgeon but haven't had recent treatments like PRP or cortisone injections.Check my eligibility
What is being tested?
The study tests the effectiveness of micro-fragmented adipose tissue (Lipogems) against saline injections in treating meniscal tears. Participants will receive one of these treatments and their pain and knee function will be monitored over a year to see if Lipogems can help avoid surgery.See study design
What are the potential side effects?
Potential side effects may include discomfort at the injection site, infection risk, allergic reactions to anesthetic agents used during the procedure, and possible swelling or bruising around the treated area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have knee pain that suggests I might have a torn meniscus.
Select...
I am between 18 and 45 years old.
Select...
My MRI or arthroscopy shows a meniscal tear with no major joint issues.
Select...
I've tried treatments like rest, medications, and physical therapy for over 4 weeks without improvement.
Select...
I experience pain, clicking, or popping in my knee, especially when twisting.
Select...
An orthopedic surgeon said I could have a type of knee surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Secondary outcome measures
Change in Numerical Rating Scale
Knee Injury and Osteoarthritis Outcome Score
PROMIS-Physical Functioning Short Form
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Micro-Fragmented Adipose TissueExperimental Treatment1 Intervention
Participants will receive a single injection of normal saline (0.9%) solution into the lesion (e.g. tear) and knee joint under ultrasound guidance using an 18 gauge x 3.5 inch needle.
Group II: SalineActive Control1 Intervention
Participants will receive a single injection of micro-fragmented adipose tissue into the lesion (e.g. tear) and knee joint under ultrasound guidance using an 18 gauge x 3.5 inch needle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lipogems
2017
Completed Phase 2
~150

Find a Location

Who is running the clinical trial?

Kessler FoundationLead Sponsor
172 Previous Clinical Trials
10,583 Total Patients Enrolled
Walter Reed National Military Medical CenterFED
136 Previous Clinical Trials
37,255 Total Patients Enrolled
Uniformed Services University of the Health SciencesFED
116 Previous Clinical Trials
91,336 Total Patients Enrolled

Media Library

Lipogems (Regenerative Medicine) Clinical Trial Eligibility Overview. Trial Name: NCT04274543 — Phase 2
Torn Meniscus Research Study Groups: Micro-Fragmented Adipose Tissue, Saline
Torn Meniscus Clinical Trial 2023: Lipogems Highlights & Side Effects. Trial Name: NCT04274543 — Phase 2
Lipogems (Regenerative Medicine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04274543 — Phase 2
Torn Meniscus Patient Testimony for trial: Trial Name: NCT04274543 — Phase 2

Frequently Asked Questions

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

Are people still eligible to enroll in this research study?

"From what is stated on clinicaltrials.gov, it appears that this trial is still recruiting patients. The study was originally posted on July 1st, 2019 and the most recent update was on October 12th, 2022."

Answered by AI

How many people have been chosen to participate in this trial?

"That is correct, the listing on clinicaltrials.gov says that this study is still looking for participants. Eighty people are needed in total, and recruitment will take place at a single site. The trial was first posted on July 1st, 2019 but was most recently updated on October 12th, 2022."

Answered by AI

Is there a danger in using Micro-Fragmented Adipose Tissue?

"Micro-Fragmented Adipose Tissue received a score of 2, as there is data affirming its safety but no evidence yet of efficacy in clinical trials."

Answered by AI

How can I join this experiment?

"This particular trial is designed for patients with flap tears who are between 18 and 45 years old. Usually, around 80 people are enrolled in studies like this."

Answered by AI

Does this research project restrict participation to those over 25 years old?

"In order to participate in this particular clinical trial, applicants must fall between the ages of 18-45. There are 132 similar studies for individuals under 18 and 630 for those over 65."

Answered by AI

Who else is applying?

What state do they live in?
New Jersey
What site did they apply to?
Kessler Foundation
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
2

Why did patients apply to this trial?

I've tried pain management also therapy of all kinds. Nothing working. I'd like to avoid another surgery.
PatientReceived 1 prior treatment
~14 spots leftby Mar 2025