Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front abdominal wall. ADRC will be administered one-time intraarticularly. This is a single arm study with no control. All patients receive cell therapy.
Patients with verified diagnosis knee joint osteoarthritis (degenerative damage of knee articular cartilage) will undergo knee arthroscopic debridement. 28 days later patients will will undergo liposuction from front abdominal wall under local anesthesia. After that autologous ADRC will be extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from harvested adipose tissue. Extracted ADRC will be administered one-time intraarticularly.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
ADRC isolation performed using Celution 800/CRS System (Cytori Therapeutics Inc) according to manufacturer's protocol
Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation; Center for Biomedical Technologies
Moscow, Russia
Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
Types, probability and severity of treatment emergent serious adverse events (SAEs) and serious adverse reactions (SARs)
Time frame: 4 weeks after treatment
Quality of life monitoring
Quality of life estimated by validated questionnaires: the Short Form (36) Health Survey (SF-36), Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Follow up to completion (up to 24 weeks after treatment)
Knee pain intensity monitoring
Knee pain intensity assessed by Visual Analogue Scale (no pain=0; maximum pain=100 mm)
Time frame: Follow up to completion (up to 24 weeks after treatment)
Changes in knee joint structures
Changes in knee joint structure assessed by: 1. X-ray (joint space width, bone contour, presence of osteophytes and sclerosis); 2. MRI (articular cartilage, osteophytes, bone marrow abnormality, meniscal integrity, synovial effusion/tissue, anterior and posterior cruciate ligaments, and medial and lateral collateral ligaments); 3. 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 function
Changes in knee function assessed by validated questionnaire: Knee Society Score (KSS)
Time frame: Follow up to completion (up to 24 weeks after treatment)
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