NCT06171204

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
8mo left

Started Sep 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress85%
Sep 2022Dec 2026

Study Start

First participant enrolled

September 19, 2022

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

November 8, 2024

Status Verified

November 1, 2024

Enrollment Period

3.3 years

First QC Date

December 6, 2023

Last Update Submit

November 6, 2024

Conditions

Knee Arthrosis

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Injection of SVF in fat pad of the kneePROCEDURE

Knee fat pad injection with SVF at orthopaedics/physical medicine outpatient clinic

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ GENT

Ghent, Oost-Vlaanderen, 9000, Belgium

RECRUITING

Central Study Contacts

Bernard Depypere, MD

CONTACT

093325730bernard.depypere@ugent.be

Jessie De Kinder

CONTACT

093321373jessie.dekinder@uzgent.be

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 6, 2023

First Posted

December 14, 2023

Study Start

September 19, 2022

Primary Completion

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Last Updated

November 8, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)