Autologous Micro-fragmented Adipose Tissue Injection for Knee Osteoarthritis

Knee Osteoarthritis Clinical Trial

Official title:

Efficacy of Autologous Micro-fragmented Adipose Tissue Intra-articular Injection for Knee Osteoarthritis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03788265
• Other study ID #: lipo-knee OA-dxs
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2016
• Est. completion date: January 1, 2021

Study information

• Verified date: April 2019
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xuesong Dai, MD., PhD
• Phone: +8687783777
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Knee osteoarthritis (OA) is characterized by loss of cartilage leading to instability, reduced range of motion, and functional limitations. Current treatment has various limitations so that alternative options to restore function and alleviate joint pain, with the ultimate goal of healing damaged articular cartilage are needed. Mesenchymal stem cells (MSCs) therapy has shown promising results. However, MSCs are limited by complex regulatory issues. Lipogems is a technique to harvest, process, and inject minimally manipulated adipose tissue through mild mechanical force. This procedure is enzyme free and requires no clonal expansion or manipulation. The goal of this study is to evaluate the possible benefits of reduced joint pain and increased joint functionality in patients with knee osteoarthritis after the injection of Lipogems.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 1, 2021
• Est. primary completion date: January 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age of eighteen or older

• Diagnosis of symptomatic knee osteoarthritis

• Radiographic evidence of knee osteoarthritis

• Failure of conservative treatment

Exclusion Criteria:

• Treatment with any intra-articular knee injection within 8 weeks before surgery

• Any disease or condition potential to interfere study outcome

• Under 18 years of age

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Lipogems
harvest and inject micro-fragment adipose tissue

Locations

Country	Name	City	State
China	Second affiliated hospital, school of medicine, Zhejiang Uni.	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Visual Analog Pain Scale (VAS) Over Time	Scaled pain score to assess change in a patient's knee pain over time. Pain level is marked on a 100 mm line with the 0 mm corresponding to "no pain" and the 100 mm corresponding to 10/10 pain. Using a ruler, the score is determined by measuring the distance (mm) on the 100 mm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).	Pre-op, then post-op: 1 month, 3 months, 6 months, 1 year, 2 years
Secondary	Change in the knee injury and osteoarthritis score (KOOS) Over Time	Patient self-reported outcome measure to assess the patient's opinion about their knee and associated issues. KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated by adding the subscales together.	Pre-op, then post-op: 1 month, 3 months, 6 months, 1 year, 2 years