Stromal vascular fraction of cells (SVF) will be extracted from lipoaspirate by enzymatic digestion. SVF will be administered in a single dose intraarticularly 4 weeks after arthroscopic debridement. All patients will receive cell therapy.This is a single arm study with no control.
Patients undergone arthroscopic debridement for 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 28 days after arthroscopy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
SVF will be isolated according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in 5 ml of Hartmann's solution.
Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation
Moscow, Russia
Orenburg City Clinical Hospital #4
Orenburg, Russia
Orenburg Regional Clinical Donor Blood Center
Orenburg, Russia
Orenburg Regional Clinical Hospital
Orenburg, Russia
SAEs monitoring
Types, probability and severity of treatment emergent serious adverse events (SAEs)
Time frame: 4 weeks after treatment
SARs monitoring
Types, probability and severity of treatment emergent serious adverse reactions (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)
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)
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)
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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)
Time frame: Follow up to completion (up to 24 weeks after treatment)