Treatment of Osteoarthritis With the Stromal Vascular Fraction of Abdominal Adipose Tissue - a Pilot Study
1 other identifier
interventional
20
1 country
1
Brief Summary
To investigate the feasibility and short term safety issues of treatment of knee osteoarthritis with intra-articular injection with the stromal vascular fraction of abdominal adipose tissue (SVF) harvested and prepared using the Lipogems System. Hereby we wish to pave the road for a high quality randomized controlled trial investigating effectiveness of treatment of knee osteoarthritis with SVF looking at patient reported outcome, function, homeostasis of the joint and cartilage regeneration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2016
1 active site
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
First Submitted
Initial submission to the registry
February 28, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedFirst Posted
Study publicly available on registry
March 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedAugust 9, 2017
August 1, 2017
1.3 years
February 28, 2016
August 8, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse events
An adverse event is defined as any event caused by the treatment leading to a less preferable situation for the patient. Patients will be screened for: Donor site morbidity: (Infection, swelling, pain). Implant site morbidity: (Infection, swelling, pain (increased VAS score))
3 months
Secondary Outcomes (2)
The Knee injury and Osteoarthritis Outcome Score
3+12 months
Numeric Rating Scale for Assessment of Pain Intensity
3+12 months
Study Arms (1)
Intervention
EXPERIMENTALAll patients are recieving the treatment.
Interventions
Description of the active treatment The active treatment is an intra-articular injection with the stromal vascular fraction (SVF) harvested from the patient's own abdominal subcutaneous fatty tissue. SVF is harvested using the Lipogems system.
Eligibility Criteria
You may qualify if:
- Age 18-70 years. Kellgren-Lawrence grade 1 - 4 evaluated on x-ray or ICRS grade 2-4 evaluated on MRI.
- The patient must be expected to be able to attend rehabilitation and post-examinations.
- The patient must be able to speak and understand Danish. The patient must be able to give informed consent.
You may not qualify if:
- Varus or valgus malalignment of the knee \> 5 degrees. BMI \> 35 Terminal illness or severe medical illness: ASA score higher than or equal to 3.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Copenhagen University Hospital Koege
Koege, 4600, Denmark
Related Publications (1)
Barfod KW, Blond L. Treatment of osteoarthritis with autologous and microfragmented adipose tissue. Dan Med J. 2019 Oct;66(10):A5565.
PMID: 31571571DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kristoffer Barfod
Copenhagen University Hospital, Hvidovre
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant, MD, PHD
Study Record Dates
First Submitted
February 28, 2016
First Posted
March 3, 2016
Study Start
March 1, 2016
Primary Completion
June 1, 2017
Study Completion
June 1, 2017
Last Updated
August 9, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will not share