Autologous, Micro-fragmented Adipose Tissue for Meniscal Tears
Condition: Tibial Meniscus Injuries; Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee; Tibial Meniscus Injuries
Intervention: Lipogems
Intervention description: 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.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 35 Years
Healthy volunteers: No

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).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 35 and older

          -  Symptoms consistent with torn meniscus (at least one of clicking popping, giving way,
             pain with pivot or torque, pain that is episodic)

          -  Pain that can be provoked by palpitation or compression of the joint line.

          -  Pain located in the medial joint line that has persisted for at least 3 months.

          -  MRI or arthroscopic evidence of meniscal tear.

          -  Failed conservative treatment which has included: anti-inflammatory or other
             medications for pain; physical therapy; injections including corticosteroid injections
             and/or hyaluronic acid injections.

          -  This would include patients who have been told by an orthopedic surgeon that they
             would be a candidate for arthroscopic partial meniscectomy.

        Exclusion Criteria:

          -  Chronically locked knee.

          -  Prior surgery performed on effected knee

          -  Assessment showing anything other than degenerative tears of the medial meniscus
             requiring surgical intervention.

          -  Recent (within 6 weeks) treatment with PRP, cortisone oral or by injection, or
             Hyaluronic injection.

          -  Any disease or condition the investigator feels would hinder treatment.

          -  Any contra-indication to lipoaspirate which includes: bleeding disorder, infection,
             pregnancy; allergy to anesthetic agents.

          -  Malignancy within the last 5 years.