Autologous, Micro-fragmented Adipose Tissue for Meniscal Tears

NCT03714659 | Completed Phase 2 Results FDA Device

• 1 other identifier: LG-MN-201
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Numerical Pain Scale

  Average knee pain between 0 (no pain) and 10 (maximum pain).

  Baseline and 12 months.

Secondary Outcomes (1)

• Change in Knee Injury and Osteoarthritis Outcome Score

  12 months.

Study Arms (1)

Intervention

EXPERIMENTAL

Group will receive a single injection of autologous, micro-fragmented adipose tissue into the torn meniscus and knee joint. The group will then be followed for one year, filling out pain and function questionnaires.

Device: Lipogems

Interventions

Lipogems DEVICE

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.

Intervention

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• New Jersey Regenerative Institute, LLC: lead

Related Publications (1)

• Malanga GA, Chirichella PS, Hogaboom NS, Capella T. Clinical evaluation of micro-fragmented adipose tissue as a treatment option for patients with meniscus tears with osteoarthritis: a prospective pilot study. Int Orthop. 2021 Feb;45(2):473-480. doi: 10.1007/s00264-020-04835-z. Epub 2020 Oct 7.

  PMID: 33026537 DERIVED

MeSH Terms

Conditions

Tibial Meniscus Injuries; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Results Point of Contact

• Title: Dr. Gerard Malanga
• Organization: New Jersey Regenerative Institute

gmalangamd@hotmail.com

9739988301

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 17, 2018
• First Posted: October 22, 2018
• Study Start: January 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: September 25, 2019
• Results First Posted: September 11, 2019

Record last verified: 2019-09