Plain English Summary
Background and study aims
Osteoarthritis (OA) is the most common type of arthritis and is a main cause of disability and pain. It occurs when the protective cartilage on the end of bones wears away. The bones then rub against one another, causing stiffness, pain and a reduction in the range of movement. The treatment for OA mostly focuses on helping relieve the pain and control symptoms instead of solving the problem. Recently there have been new ideas and technology in orthopedic surgery (surgery that corrects bones and muscles) that has come up with alternative treatments. Using adipose tissues (fat cells) from a patient could help repair the bones and cartilage if it is injected into the area affected with OA. The new Lipogems® technology is a closed system that is designed to harvest, process and inject adipose tissues back into patients to help repair the area with OA. The aim of this study is to evaluate the outcomes of treating patients with knee osteoarthritis and cartilage lesions with adipose tissue to see if it helped improve the knee’s function and reduce pain.
Who can participate?
Patients aged 40-85 years old with knee osteoarthritis.
What does the study involve?
Participants undergo a physical examination and complete a health questionnaire. They then undergo a surgical procedure using the Lipogems system® which takes fat tissues from the patient's stomach area and then reinjects the fat tissues into the knees. Participants have a blood sample collected during the procedure and as well in the follow up at six and 12 months. They are followed up at three, six and 12 months after procedure to assess the pain level and the function the knee.
What are the possible benefits and risks of participating?
A potential benefit for patients is pain reduction and functional improvement of the affected knee. The main risks are haematoma (swelling) at area where the adipose tissue is taken from and short-term knee pain after the procedure. Participants may feel discomfort during the blood test.
Where is the study run from?
1. Specialty Hospital St. Catherine (Croatia)
2. Genos Ltd. laboratory (Croatia)
When is the study starting and how long is it expected to run for?
September 2015 to January 2018
Who is funding the study?
Specialty Hospital St. Catherine and Genos Ltd. Laboratory (Croatia)
Who is the main contact?
Dr. Andrea Skelin
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
EP 001/2016
Study information
Scientific title
Application of adipose derived mesenchymal stem cells (Ad-MSC) in treating OSTeoarticular and Cartilage lesions
Acronym
OSCT
Study hypothesis
The aim of this study is to explore trophic, mitogenic, anti-scarring, anti-apoptotic, immunomodulatory, and anti-microbial clinical effects of autologous adipose-derived stromal/stem cells (Ad-MSC) in treating patients with osteoarticular and cartilage lesions.
Ethics approval
St. Catherine Hospital Ethic Committee, 18/1/2016, ref: EP 001/2016
Study design
Non randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format
Condition
Knee osteoarthritis
Intervention
Participants undergo a complete physical examination including X-rays/MRI and biochemical laboratory tests. Participants also complete a specific questionnaire (International Knee Documentation Committee (IKDC)) to assess their health.
Participants then undergo a surgical procedure (lipoaspiration). The Lipogems® technology, patented in 2010 (PCT/IB2011/052204), is a completely closed tool to harvest, wash, process, and reinject human (or animal) lipoaspirates. This surgical procedure consists of two steps: the infiltration step, in which adrenaline, in a saline solution, and very diluted lidocaine are injected to induce vasoconstriction as well as local anesthesia is injected to facilitate the subsequent lipoaspiration and the aspiration step, in which a standard liposuction technique is performed. The tissue is taken from the abdominal subcutaneous adipose tissue.
They then receive intra-articular injection of final product containing derivate of micronized fatty tissue and intact vascular/stromal architecture with pericytes and mesenchymal stem cells (Ad-MSC) into affected knee (or knees)
Participants have plasma blood collection and synovial fluid aspirates of IgG glycom analyses taken during the procedure and 6 and 12 months.
Followed up is done at baseline, 3, 6 and 12 months to measure the pain level and the functioning of the knee (or knees). In addition MRI and dGEMRIC MRI imaging are performed at baseline and at 3, 6 and 12 months.
Intervention type
Device
Phase
Drug names
Primary outcome measure
1. Pain in the knee is measured using the visual analogue scale (VAS) at the baseline, 3, 6 and 12 months
2. Function of the knee is measured using Knee Injury and Osteoarthritis Outcome Score (KOOS) at baseline, 3, 6 and 12 months
Secondary outcome measures
1. Matrix synthesis in the cartilage layer (glycosaminoglycan content) delayed gadolinium enhanced MRI (dGEMRIC) imaging technique is applied at the baseline, 3, 6 and 12 months.
2. Changes in IgG glycosylation associated with inflammatory processes analyses of IgG glycom from the blood plasma and synovial fluid (when available) is performed at baseline, 6 and 12 months
3. Subchondral bone edema, morphology of cartilage and soft tissues is measured by MRI scans at baseline and at 3, 6 and 12 months
Overall trial start date
14/09/2015
Overall trial end date
18/01/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age 40-85
2. Knee osteoarthritis (radiological Kellgren and Lawrence grade II-IV)
3. Onset of symptoms for more than 6 months in the painful knee
4. Able to follow the instructions of the study
5. Signed an informed consent form
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Age less than 40 years or more than 85 years
2. Chondromatosis or villonodular synovitis of the knee
3. Recent trauma (<3 month) of the symptomatic knee
4. Infectious joint disease
5. Malignancy
6. Patients on anticoagulant therapy with PT ( < 0,70) or suffering from thrombocytopenia and/or coagulation disorder
7. Hypersensitivity to local anaesthetic
Recruitment start date
18/01/2016
Recruitment end date
16/06/2017
Locations
Countries of recruitment
Croatia
Trial participating centre
Specialty Hospital St. Catherine
Bračak 8
Zabok
49210
Croatia
Trial participating centre
Genos Ltd. Laboratory
Hondlova 2/11
Zagreb
10000
Croatia
Sponsor information
Organisation
Specialty Hospital St. Catherine
Sponsor details
Bračak 8
Zabok
49210
Croatia
Sponsor type
Hospital/treatment centre
Website
Organisation
Genos Ltd. Laboratory
Sponsor details
Hondlova 2/11
Zagreb
10000
Croatia
Sponsor type
Research organisation
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Specialty Hospital St. Catherine
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Genos Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The first preliminary data we are planning to present at the 10th International Society for Applied Biological Sciences (ISABS) Conference to be held in June 2017. Planned publication in a high-impact peer reviewed journal in 2019.
IPD sharing plan:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication,
Intention to publish date
31/01/2019
Participant level data
Not expected to be available
Basic results (scientific)
Publication list