Status:
UNKNOWN
The Evaluation of Safety and Effectiveness of Intraarticular Administration of Autologous Stromal-Vascular Fraction of Adipose Tissue Cells for Treatment of Knee Joint Arthrosis
Lead Sponsor:
Swiss Medica XXI Century S.A.
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
20-85 years
Phase:
PHASE2
Brief Summary
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....
Detailed Description
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 enzymat...
Eligibility Criteria
Inclusion
- Pain in the knee joint during more than a half day assessed by Visual Analog Pain Scale (score more than 40 mm)
- At least three of the following 6 criteria: 20-85 years of age, stiffness lasting less than 30 minutes, crepitus, bony tenderness, bony enlargement, no warmth to the touch
- Patient is able to walk without assistance
- Patient is familiar with Participant information sheet
- Patient signed informed consent form
- Non-inclusion Criteria:
- Medical history of endoprosthetic knee replacement
- Medical history of lower extremity osteotomy
- Medical history of knee surgery (including arthroscopy) during preceding 1 year prior to enrollment
- Medical history of intraarticular injections during preceding 6 months prior to enrollment
- Secondary osteoarthritis of the knee joint: posttraumatic osteoarthritis (developed after clinically significant injury), intra-articular fractures, clinically significant varus or valgus deformities of lower limbs, septic arthritis, joint's inflammatory disorders, gout, advanced chondrocalcinosis, Paget's disease, ochronosis, acromegaly, hemochromatosis, Wilson's disease, primary synovial osteochondromatosis, osteonecrosis, hemophilia
- Patients prescribed for immunosuppressive treatment
- Medical history of systemic autoimmune and inflammatory diseases
- Significant weight loss (\> 10% of body weight in the previous year) of unknown etiology
- Medical history of venous thromboembolism or estimated high risk of venous thromboembolism
- Patients prescribed for systemic corticosteroids or other medications treatment with proven impact on bone or cartilage tissue metabolism
- Clinically significant abnormalities in results of laboratory tests
- Any conditions limiting compliance (dementia, neuropsychiatric disease, drug and alcohol abuse etc.)
- Participation in other clinical trials (or administration of investigational drugs) during 3 months prior inclusion
- Patients with malignant tumors including postoperative period, patients receiving chemotherapy and/or radiotherapy.
- Patient's activated partial thromboplastin time exceeds normal levels more than 1,8 times
- Patients prescribed for anticoagulants treatment or patient received anticoagulants at least one hour prior liposuction
- Medical history of heterotopic ossifications
- Patients prescribed for glycoprotein inhibitors treatment
Exclusion
- Patient's refusal from the further participation in trial
- Patient's refusal from compliance with the requirements of contraception during the participation in research
- Chronic kidney disease IV- V stages (creatinine clearance \< 30 mL/min estimated by Cockcroft-Gault formula)
- Confirmed syphilis, HIV, hepatitis B or C infections
- Dropout Criteria:
- \- Pregnancy
Key Trial Info
Start Date :
August 21 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 22 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04050111
Start Date
August 21 2019
End Date
August 22 2021
Last Update
August 8 2019
Active Locations (2)
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1
Swiss Medica XXI Century S.A.
Moscow, Russia, 127521
2
IM Clinic
Belgrade, Serbia