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Autologous, Micro-fragmented Adipose Tissue for Meniscal Tears

NCT03714659 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-09-25

Study results available
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Summary

The menisci of the knee are essential fibro-cartilaginous structures that contribute in static weight bearing, distributing compressive forces during joint movement, joint lubrication, joint stabilization, and proprioception. The menisci are commonly torn, interfering with these vital functions, with an estimated mean annual incidence as high as 60-70 per 100,000 knee injuries. When torn, the odds of developing future osteoarthritis within 2 years of follow-up can be as high as 5.92. The management of meniscal tears remains a challenge given the poor intrinsic healing capacity of tears occurring in the inner, avascular, portion of the meniscus where direct surgical repair techniques are commonly unsuccessful. Autologous adipose tissue injection has recently emerged as a promising new treatment for joint pain and soft tissue injury. Adipose can be used to provide cushioning and filling of structural defects and has been shown to have an abundance of bioactive elements and regenerative perivascular cells (pericytes).The aim of this study is to explore the potential of Lipogems® micro-fragmented adipose tissue as a meaningful treatment option for meniscus tears. Patients treated with MFAT with intra-meniscal injections under continuous ultrasound guidance are expected to report clinically meaningful improvements in knee pain and knee function after one year. Knee pain and function will be measured using a numerical pain scale (NPS) and the Knee Injury and Osteoarthritis Outcome Scale (KOOS).

Conditions

  • Tibial Meniscus Injuries
  • Osteoarthritis, Knee

Interventions

DEVICE

Lipogems

Lipogems is a closed-loop system designed to break up adipose tissue into micro-fragmented adipose tissue without additives; therefore, meeting FDA requirements for minimal manipulation. A small volume of adipose tissue is harvested from the abdomen, thigh, or other location. The lipoaspirate is fed into the device through a reduction filter, and is then cleansed of blood and oil residues using a sterile saline solution. This fat-saline solution is then shaken for 30 seconds in a device containing stainless steel ball bearings, which further fragments and washes the lipoaspirate. Once the tissue is purified and fragmented, it is collected in 10cc sterile syringes and subsequently injected into the meniscus and knee joint.

Sponsors & Collaborators

  • New Jersey Regenerative Institute, LLC

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2018-03-01
Completion
2018-03-01
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03714659 on ClinicalTrials.gov