Official Title

The Evaluation of Safety and Effectiveness of Intraarticular Administration of Autologous Stromal-Vascular Fraction of Adipose Tissue Cells for Treatment of Knee Joint Arthrosis
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Status

    Unknown status
  • Study Participants

    30
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.
Study Started
Aug 21
2019
Anticipated
Primary Completion
Feb 22
2021
Anticipated
Study Completion
Aug 22
2021
Anticipated
Last Update
Aug 08
2019

Biological Stromal-vascular fraction

Concentrate of stromal-vascular fraction of cells derived from autologous adipose tissue

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

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 Results Posted