Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Stromal vascular fraction of cells (SVF) will be extracted from lipoaspirate by enzymatic digestion. SVF will be administered in a single dose intraarticularly. All patients will receive cell therapy.This is a single arm study with no control.
Patients with 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.
Not provided
Not provided
Not provided
Not provided
| 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. Interventions: Procedure: Liposuction Other: SVF isolation Other: Intraarticular administration of autologous SVF |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stromal-vascular fraction | Biological | Concentrate of stromal-vascular fraction of cells derived from autologous adipose tissue |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serious adverse events (SAEs) | Types, probability and severity of treatment emergent SAEs | 4 weeks after treatment |
| Serious adverse reactions (SARs) | Types, probability and severity of treatment emergent 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). SF-36 is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. The eight sections are:
|
Not provided
Inclusion Criteria:
Non-inclusion Criteria:
Exclusion Criteria:
Dropout Criteria:
- Pregnancy
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sergey L Mikheev, MD, PhD | Contact | +7-495-6180116 | mikheev@swissmedica21.com | |
| Ilya I Eremin | Contact | +7-495-6180116 | ieremin@swissmedica21.com |
| Name | Affiliation | Role |
|---|---|---|
| Sergey L Mikheev, MD, PhD | Head of Swiss Medica XXI Century S.A. | Principal Investigator |
| Ilya I Eremin, MD, PhD | Chief scientific officer of Swiss Medica XXI Century S.A. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swiss Medica XXI Century S.A. | Moscow | 127521 | Russia |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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). The KOOS is a patient reported joint-specific score, which assesses:
Scores range from 0 to 100 with a score of 0 indicating the worst possible knee symptoms and 100 indicating no knee symptoms. | 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). KSS consists of 4 separate sub-scales:
Lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions. | Follow up to completion (up to 24 weeks after treatment) |
| IM Clinic | Belgrade | Serbia |
|
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided