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| Name | Class |
|---|---|
| Orenburg Regional Clinical Blood Donor Center | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SVF injection | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposuction | Procedure |
| ||
| SVF isolation |
| Measure | Description | Time Frame |
|---|---|---|
| SAEs monitoring | Types, probability and severity of treatment emergent serious adverse events (SAEs) | 4 weeks after treatment |
| SARs monitoring | Types, probability and severity of treatment emergent serious adverse reactions (SARs) | 4 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life monitoring-1 | Quality of life estimated by validated questionnaire - the Short Form (36) Health Survey (SF-36) | Follow up to completion (up to 24 weeks after treatment) |
| Quality of life monitoring-2 |
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Inclusion Criteria:
Non-inclusion Criteria:
Exclusion Criteria:
Dropout Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ilya I Eremin, MD, PhD | 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 | Principal Investigator |
| Rinat G Gilmutdinov, MD, PhD | Orenburg Regional Clinical Donor Blood Center | Principal Investigator |
| Sergey I Gilfanov, MD, PhD, Prof | Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation | Principal Investigator |
| Andrey A Averyanov, MD, PhD | Orenburg Regional Clinical Hospital | Principal Investigator |
| Vadim A Kopylov, MD, PhD | Orenburg City Clinical Hospital #4 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federal State Budgetary Institution "Central Clinical Hospital with Outpatient Health Center" of the Business Administration for the President of the Russian Federation | Moscow | 121359 | Russia |
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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. |
|
| Intraarticular administration of autologous SVF | Other |
|
Quality of life estimated by validated questionnaire - Knee Injury and Osteoarthritis Outcome Score (KOOS)
| 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) | 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) | 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) | 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) | 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) | Follow up to completion (up to 24 weeks after treatment) |
| Orenburg City Clinical Hospital #4 | Orenburg | 460000 | Russia |
| Orenburg Regional Clinical Donor Blood Center | Orenburg | 460018 | Russia |
| Orenburg Regional Clinical Hospital | Orenburg | 460018 | Russia |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D015187 | Lipectomy |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
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