Treatment of Osteoarthritis With the Stromal Vascular Fraction of Abdominal Adipose Tissue - a Pilot Study
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|ClinicalTrials.gov Identifier: NCT02697682|
Recruitment Status : Completed
First Posted : March 3, 2016
Last Update Posted : August 9, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Stem Cells||Biological: injection with the stromal vascular fraction (SVF) of adipose tissue||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Osteoarthritis With the Stromal Vascular Fraction of Abdominal Adipose Tissue - a Pilot Study|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||June 2017|
|Actual Study Completion Date :||June 2017|
All patients are recieving the treatment.
Biological: injection with the stromal vascular fraction (SVF) of adipose tissue
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.
- Adverse events [ Time Frame: 3 months ]
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))
- The Knee injury and Osteoarthritis Outcome Score [ Time Frame: 3+12 months ]The KOOS holds 42 items in five separately scored subscales: KOOS Pain, KOOS Symptoms, Function in daily living (KOOS ADL), Function in Sport and Recreation (KOOS Sport/Rec), and knee-related Quality of Life (KOOS QOL)
- Numeric Rating Scale for Assessment of Pain Intensity [ Time Frame: 3+12 months ]For assessment of pain intensity, the 11-step numeric rating scale (NRS-11) is chosen. The scale goes from 0 to10, with 0 equalling no pain and 10 being the worst possible pain
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02697682
|Copenhagen University Hospital Koege|
|Koege, Denmark, 4600|
|Principal Investigator:||Kristoffer Barfod||Copenhagen University Hospital, Hvidovre|