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Autologous, Micro-fragmented Adipose Tissue for Meniscal Tears

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ClinicalTrials.gov Identifier: NCT03714659
Recruitment Status : Completed
First Posted : October 22, 2018
Results First Posted : September 11, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Gerard Malanga, New Jersey Regenerative Institute, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Tibial Meniscus Injuries
Osteoarthritis, Knee
Intervention Device: Lipogems
Enrollment 20
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 20
Completed 19
Not Completed 1
Arm/Group Title Intervention
Hide Arm/Group Description

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.

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.

Overall Number of Baseline Participants 19
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants
60.5  (6.6)
[1]
Measure Description: Participants were asked their age in years at the time of the intervention.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants
Female
9
  47.4%
Male
10
  52.6%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Change in Numerical Pain Scale
Hide Description Average knee pain between 0 (no pain) and 10 (maximum pain).
Time Frame Baseline and 12 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.2  (3.6)
2.Secondary Outcome
Title Change in Knee Injury and Osteoarthritis Outcome Score
Hide Description 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.
Time Frame 12 months.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Intervention
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 19
Mean (Standard Deviation)
Unit of Measure: units on a scale
Pain 17.5  (20.2)
Activities of Daily Living 17.3  (20.7)
Symptoms 20.5  (18.1)
Quality of Life 26.3  (28.9)
Sports/Recreation 28.4  (31.5)
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Intervention
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention
Affected / at Risk (%)
Total   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Gerard Malanga
Organization: New Jersey Regenerative Institute
Phone: 9739988301
EMail: gmalangamd@hotmail.com
Layout table for additonal information
Responsible Party: Gerard Malanga, New Jersey Regenerative Institute, LLC
ClinicalTrials.gov Identifier: NCT03714659     History of Changes
Other Study ID Numbers: LG-MN-201
First Submitted: October 17, 2018
First Posted: October 22, 2018
Results First Submitted: August 19, 2019
Results First Posted: September 11, 2019
Last Update Posted: September 25, 2019