NCT03714659

Autologous, Micro-fragmented Adipose Tissue for Meniscal Tears

Completed Phase 2 Results posted Last updated 25 September 2019

What this trial tests

Phase 2 trial testing Lipogems in Tibial Meniscus Injuries in 20 participants. Completed in 1 March 2018.

Timeline

1 January 2017

Primary endpoint
1 March 2018

1 March 2018

Quick facts

Lead sponsor	New Jersey Regenerative Institute, LLC
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 January 2017
Primary completion	1 March 2018
Estimated completion	1 March 2018

Drugs / interventions tested

• Lipogems

Conditions studied

• Tibial Meniscus Injuries — all drugs for Tibial Meniscus Injuries →
• Osteoarthritis, Knee — all drugs for Osteoarthritis, Knee →

Sponsor

New Jersey Regenerative Institute, LLC — full company profile →

Who can join

35 and older, any sex, with Tibial Meniscus Injuries or Osteoarthritis, Knee. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Numerical Pain Scale Primary · Baseline and 12 months.

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

Group	Value	95% CI
Intervention	-3.2	± 3.6

Change in Knee Injury and Osteoarthritis Outcome Score Secondary · 12 months.

A scale with five subdomains that aim to capture pain, symptoms, functional limitations, and effects on quality of life caused by (in this study) meniscal injury. Each subdomain is measured from 0 (complete impairment) to 100 (no impairment). A higher score indicates less pain or better function.

Pain

Group	Value	95% CI
Intervention	17.5	± 20.2

Activities of Daily Living

Group	Value	95% CI
Intervention	17.3	± 20.7

Symptoms

Group	Value	95% CI
Intervention	20.5	± 18.1

Quality of Life

Group	Value	95% CI
Intervention	26.3	± 28.9

Sports/Recreation

Group	Value	95% CI
Intervention	28.4	± 31.5

Sponsor's own description

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).

Publications & conference data

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

1. 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
2. Non-homologous use of adipose-derived cell and tissue therapies: Osteoarthritis as a case study.
   Frazier T, March K, Garza JR, Bunnell BA, et al · · 2022 · cited 8× · PMID 35874168 · DOI 10.1016/j.bonr.2022.101601