The Use of Stromal Vascular Fraction for Knee Arthrosis

Gebruik Van Stromale Vasculaire Fractie Uit Vetweefsel Na Invriezing Voor Knie Arthrose

A trial to investigate the safety and efficacy of SVF for the treatment of knee arthrosis.

Patients will undergo a single liposuction to obtain the SVF. The SVF will then be isolated and frozen in our laboratory. The SVF will then be injected up to 2 times into the fat pad of the patient's knee.

Study Overview

• Status: Recruiting
• Conditions: Knee Arthrosis
• Intervention / Treatment: Procedure: Injection of SVF in fat pad of the knee

Detailed Description

Stromal Vascular Fraction (SVF) from adipose tissue is increasingly being used in the clinic for a variety of conditions (skin disorders, joint pain, etc.). SVF is a collective term for cells that can be obtained from liposuction fat. These cells can be separated from the fat by mechanical processing of the liposuction fat combined with an additional centrifugation.

Despite the fact that enough SVF can be isolated after such a liposuction for multiple treatments (>3), our research group has found a way to safely freeze SVF without significant loss of SVF cells. In this way, a patient would only have to undergo one liposuction and associated anesthesia to be able to obtain multiple SVF treatments.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bernard Depypere, MD; Phone Number: 093325730; Email: bernard.depypere@ugent.be
• Study Contact Backup: Name: Jessie De Kinder; Phone Number: 093321373; Email: jessie.dekinder@uzgent.be

Study Locations

• Belgium
  • Oost-Vlaanderen
    • Gent, Oost-Vlaanderen, Belgium, 9000
      • Recruiting
      • UZ Gent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Legal capacity
• Osteochondral lesions
• Inflammatory complaints
• (Peri)tendinitis or tendinopathies and ligamentous injuries
• Impingement complaints
• Arthrofibrosis
• Anterior knee pain

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the safety of SVF injections after cryo preservation	The patient will complete the KOOS questionnaire (Knee Injury and Osteoarthritis Outcome Score) on several timepoints.	1 year

Collaborators and Investigators

• Sponsor: University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 6, 2023
• First Submitted That Met QC Criteria: December 6, 2023
• First Posted (Actual): December 14, 2023

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Rheumatic Diseases; Joint Diseases; Osteoarthritis
• Other Study ID Numbers: BC-07772

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No