NCT04274543

Ultrasound-Guided Injections for Meniscal Injuries in Active-Duty Military

Completed Phase 2 Last updated 18 December 2024

What this trial tests

Phase 2 trial testing Lipogems in Tibial Meniscus Injuries in 3 participants. Completed in 1 December 2024.

Timeline

1 July 2019

Primary endpoint
1 December 2024

1 December 2024

Quick facts

Lead sponsor	Kessler Foundation
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	3
Start date	1 July 2019
Primary completion	1 December 2024
Estimated completion	1 December 2024
Sites	1 location across United States

Drugs / interventions tested

• Lipogems
• Normal Saline

Conditions studied

• Tibial Meniscus Injuries — all drugs for Tibial Meniscus Injuries →
• Knee Injuries — all drugs for Knee Injuries →
• Knee Injuries and Disorders — all drugs for Knee Injuries and Disorders →

Sponsor

Kessler Foundation

Who can join

Adults 18 to 45, any sex, with Tibial Meniscus Injuries or Knee Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Knee injuries are common among active-duty military personnel. One of the most common knee injuries is a meniscus tear, which can have several consequences. Immediately, the soldier may be separated from the military for over one year or assigned a permanent activity limiting duty profile. Over time, meniscal tears may also increase the risk of other knee injuries, such as osteoarthritis, which is one of the most common medical reasons for discharge from active duty service. The current standard of care includes conservative treatments, such as physical therapy and rest. Once conservative treatments fail, surgery is generally the next option. However, there is limited evidence that surgery is effective and some studies suggest it can accelerate the development of osteoarthritis. The goal of this study is to evaluate the efficacy of a regenerative treatment for meniscal tears termed micro-fragmented adipose tissue in reducing pain and restoring activity levels. We will recruit active-duty military personnel and civilians with meniscal tears and provide them with either the adipose tissue treatment or a control treatment consisting of saline. We will then follow these individuals for up to one year and evaluate differences in pain and function between the two groups. The ultimate goal is to show that micro-fragmented adipose tissue is a viable alternative for the treatment of meniscal tears in active-duty military personnel.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Clinical Trials of Mesenchymal Stromal Cells Therapy.
   Kouchakian MR, Baghban N, Moniri SF, Baghban M, et al · · 2021 · cited 30× · PMID 34745268 · DOI 10.1155/2021/1634782
2. Clinical evaluation of micro-fragmented adipose tissue as a treatment option for patients with meniscus tears with osteoarthritis: a prospective pilot study.
   Malanga GA, Chirichella PS, Hogaboom NS, Capella T. · · 2021 · cited 22× · PMID 33026537 · DOI 10.1007/s00264-020-04835-z
3. Wharton's jelly mesenchymal stem cells: Future regenerative medicine for clinical applications in mitigation of radiation injury.
   Sharma P, Maurya DK. · · 2024 · cited 12× · PMID 39086560 · DOI 10.4252/wjsc.v16.i7.742
4. Pericytes and Diabetic Microangiopathies: Tissue Resident Mesenchymal Stem Cells with High Plasticity and Regenerative Capacity.
   Shirbaghaee Z, Sorenson CM, Sheibani N. · · 2025 · cited 1× · PMID 40508141 · DOI 10.3390/ijms26115333