Trial Outcomes & Findings for Autologous, Micro-fragmented Adipose Tissue for Meniscal Tears (NCT NCT03714659)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

20 participants

Primary outcome timeframe

Baseline and 12 months.

Results posted on

2019-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention 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 Study STARTED	20
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=19 Participants 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.
Age, Continuous	60.5 years STANDARD_DEVIATION 6.6 • n=19 Participants
Sex: Female, Male Female	9 Participants n=19 Participants
Sex: Female, Male Male	10 Participants n=19 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months.

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

Outcome measures

Outcome measures
Measure	Intervention n=19 Participants 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.
Change in Numerical Pain Scale	-3.2 units on a scale Standard Deviation 3.6

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=19 Participants 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.
Change in Knee Injury and Osteoarthritis Outcome Score Pain	17.5 units on a scale Standard Deviation 20.2
Change in Knee Injury and Osteoarthritis Outcome Score Activities of Daily Living	17.3 units on a scale Standard Deviation 20.7
Change in Knee Injury and Osteoarthritis Outcome Score Symptoms	20.5 units on a scale Standard Deviation 18.1
Change in Knee Injury and Osteoarthritis Outcome Score Quality of Life	26.3 units on a scale Standard Deviation 28.9
Change in Knee Injury and Osteoarthritis Outcome Score Sports/Recreation	28.4 units on a scale Standard Deviation 31.5

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gerard Malanga

New Jersey Regenerative Institute

Phone: 9739988301

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place