Clinical trial: The Evaluation of Safety and Effectiveness of Intraarticular Administration of Autologous Stromal-Vascular Fraction of Adipose Tissue Cells for Treatment of Knee Joint Arthrosis (NCT04050111)

Eligibility criteria:
Inclusion Criteria:

          -  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 Criteria:

          -  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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 20 Years old.
Subject must be at most 85 Years

Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? Entailment