Autologous Micro-fragmented Adipose Tissue Injection for Knee Osteoarthritis

Zhejiang University

Status: Unknown

Conditions: Knee Osteoarthritis

Treatments: Device: Lipogems

Study type: Interventional

Funder types: Other

Identifiers

NCT03788265

lipo-knee OA-dxs

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

injection

Experimental group

Treatment:

Device: Lipogems