A Phase 2 interventional study of Liposuction and SVF isolation in Knee Osteoarthritis, sponsored by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation. Status unknown at 4 sites in Russia. Open to participants aged 20 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-07-21.
Sponsored by Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation · Phase 2, Interventional, and Treatment
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.
3,391 studies on the registry are indexed under Osteoarthritis, Knee; 628 are open to participants now.
This study's planned enrollment of 200 is above the median of 69 across 2,808 interventional studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation is the lead sponsor of 9 studies on the registry; none are open to participants now.
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Non-inclusion Criteria:
Exclusion Criteria:
Dropout Criteria:
Subjects will undergo liposuction under local anesthesia. Lipoaspirate will be processed to isolate and concentrate stromal vascular fraction of cells (SVF). After SVF isolation autologous cells suspension will be injected intraarticularly into knee joint.
Procedure: Liposuction · Other: SVF isolation · Other: Intraarticular administration of autologous SVF
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.
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)
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)
Plan to share: Undecided
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This study is status unknown, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation