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| Name | Class |
|---|---|
| I.M. Sechenov First Moscow State Medical University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADRC injection | Experimental | Subjects will undergo liposuction under local anesthesia. Lipoaspirate will be processed to isolate and concentrate adipose-derived regenerative cells (ADRC). After ADRC isolation autologous cells suspension will be injected intraarticularly into knee joint. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arthroscopic surgery | Procedure |
| ||
| Liposuction |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 4 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Follow up to completion (up to 24 weeks after treatment) |
| Knee pain intensity monitoring |
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Inclusion Criteria:
Non-inclusion Criteria:
Exclusion Criteria:
Dropout Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergey V Ivannikov, Professor | I.M. Sechenov First Moscow State Medical University | Principal Investigator |
| 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 |
| 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; Center for Biomedical Technologies | Moscow | 121359 | Russia |
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| ADRC isolation | Device | ADRC isolation performed using Celution 800/CRS System (Cytori Therapeutics Inc) according to manufacturer's protocol |
|
| Intraarticular administration of autologous ADRC | Other |
|
Knee pain intensity assessed by Visual Analogue Scale (no pain=0; maximum pain=100 mm) |
| Follow up to completion (up to 24 weeks after treatment) |
| Changes in knee joint structures | Changes in knee joint structure assessed by:
| 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) |
| ID | Term |
|---|---|
| D001182 | Arthroscopy |
| D015187 | Lipectomy |
| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019637 | Orthopedic Procedures |
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D019651 | Plastic Surgery Procedures |
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