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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
Sponsor:
Information provided by (Responsible Party):
Kristoffer Barfod, Hvidovre University Hospital

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.


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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Intervention
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.




Primary Outcome Measures :
  1. 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))



Secondary Outcome Measures :
  1. 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)

  2. 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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.


Information from the National Library of Medicine

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


Locations
Denmark
Copenhagen University Hospital Koege
Koege, Denmark, 4600
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
Principal Investigator: Kristoffer Barfod Copenhagen University Hospital, Hvidovre

Responsible Party: Kristoffer Barfod, Consultant, MD, PHD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT02697682     History of Changes
Other Study ID Numbers: OA-SVF-pilot
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases