Stromal vascular fraction of cells (SVF) will be extracted from lipoaspirate by enzymatic digestion. SVF will be administered in a single dose intraarticularly. All patients will receive cell therapy.This is a single arm study with no control.
Patients with knee osteoarthritis will be subjected to abdominal liposuction under local anaesthesia. Harvested adipose tissue will be processed according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in 5 ml of Hartmann's solution. Isolated SVF will be administered in a single dose into anterior part of knee joint cavity.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Concentrate of stromal-vascular fraction of cells derived from autologous adipose tissue
Swiss Medica XXI Century S.A.
Moscow, Russia
IM Clinic
Belgrade, Serbia
Serious adverse events (SAEs)
Types, probability and severity of treatment emergent SAEs
Time frame: 4 weeks after treatment
Serious adverse reactions (SARs)
Types, probability and severity of treatment emergent SARs
Time frame: 4 weeks after treatment
Quality of life monitoring-1
Quality of life estimated by validated questionnaire - the Short Form (36) Health Survey (SF-36). SF-36 is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are: * vitality * physical functioning * bodily pain * general health perceptions * physical role functioning * emotional role functioning * social role functioning * mental health
Time frame: Follow up to completion (up to 24 weeks after treatment)
Quality of life monitoring-2
Quality of life estimated by validated questionnaire - Knee Injury and Osteoarthritis Outcome Score (KOOS). The KOOS is a patient reported joint-specific score, which assesses: * patient pain (9 items), * other symptoms (7 items), * function in daily living (17 items), * function in sport and recreation (5 items), * knee related quality of life (4 items). Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms.
Time frame: Follow up to completion (up to 24 weeks after treatment)
Knee pain intensity monitoring
Knee pain intensity assessed by Visual Analog Pain Scale (no pain=0; maximum pain=100 mm)
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Time frame: Follow up to completion (up to 24 weeks after treatment)
Changes in knee joint structure-1
Changes in knee joint structure assessed by ultrasonography (effusion, synovial thickening or hypertrophy, cartilage parameters, vascularity, Baker's cysts, osteophytes, tendon and ligament abnormalities, meniscal changes, bursitis, erosions and panniculitis)
Time frame: Follow up to completion (up to 24 weeks after treatment)
Changes in knee joint structure-2
Changes in knee joint structure assessed by X-ray (joint space width, bone contour, presence of osteophytes and sclerosis)
Time frame: Follow up to completion (up to 24 weeks after treatment)
Changes in knee joint structure-3
Changes in knee joint structure assessed by MRI (articular cartilage, osteophytes, bone marrow abnormality, meniscal integrity, synovial effusion/tissue, anterior and posterior cruciate ligaments, and medial and lateral collateral ligaments)
Time frame: Follow up to completion (up to 24 weeks after treatment)
Changes in knee function
Changes in knee function assessed by validated questionnaire: Knee Society Score (KSS). KSS consists of 4 separate sub-scales: * "Objective" Knee Score (seven items: 100 points), * Patient Satisfaction Score (five items: 40 points), * Patient Expectation Score (three items: 15 points), * Functional Activity Score (19 items: 100 points). Lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Time frame: Follow up to completion (up to 24 weeks after treatment)