Autologous Micro-fragmented Adipose Tissue Injection for Knee Osteoarthritis

NCT ID: NCT03788265

Last Updated: 2019-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-01

Study Completion Date

2021-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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injection

Group Type EXPERIMENTAL

Lipogems

Intervention Type DEVICE

harvest and inject micro-fragment adipose tissue

Interventions

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Lipogems

harvest and inject micro-fragment adipose tissue

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Second affiliated hospital, school of medicine, Zhejiang Uni.

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xuesong Dai, MD., PhD

Role: CONTACT

+8687783777

Facility Contacts

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Xuesong Dai

Role: primary

+8687783777

Other Identifiers

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lipo-knee OA-dxs

Identifier Type: -

Identifier Source: org_study_id

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