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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) will be extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front abdominal wall. Patients will undergo knee arthroscopic surgery followed by one-time intraarticular ADRC administration (directly into anterior cruciate ligament). This is a single arm study with no control. All patients receive cell therapy.
Patients with verified diagnosis partial rupture of anterior cruciate ligament 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. Same day patients will undergo knee arthroscopic surgery followed by one-time intraarticular freshly isolated ADRC administration (directly into anterior cruciate ligament close to the rupture).
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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 anterior cruciated ligament. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposuction | Procedure |
| ||
| ADRC isolation |
| Measure | Description | Time Frame |
|---|---|---|
| Number of serious adverse events (SAEs) and serious adverse reactions (SARs) | 2 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 performed using Celution 800/CRS System (Cytori Therapeutics Inc) according to manufacturer's protocol |
|
| Arthroscopic surgery | Procedure |
|
| 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 questionnaire: Knee Society Score (KSS) | Follow up to completion (up to 24 weeks after treatment) |
| ID | Term |
|---|---|
| D015187 | Lipectomy |
| D001182 | Arthroscopy |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
| D019637 | Orthopedic Procedures |
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