Status:
COMPLETED
Effectiveness and Safety of Autologous ADRC for Treatment of Degenerative Damage of Knee Articular Cartilage
Lead Sponsor:
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
Collaborating Sponsors:
I.M. Sechenov First Moscow State Medical University
Conditions:
Knee Joint Osteoarthritis
Eligibility:
All Genders
20-85 years
Phase:
PHASE1
PHASE2
Brief Summary
Autologous adipose-derived regenerative cells (ADRC) extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front abdominal wall. ADRC...
Detailed Description
Patients with verified diagnosis knee joint osteoarthritis (degenerative damage of knee articular cartilage) will undergo knee arthroscopic debridement. 28 days later patients will will undergo liposu...
Eligibility Criteria
Inclusion
- Pain in the knee joint during more than a half day assessed by VAS (score more than 40 mm)
- At least three of the following 6 criteria: 50 years of age or older, 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 lipoaspiration
- 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 Cockroft-Gault formula)
- Confirmed syphilis, HIV, hepatitis B or C infections
- Dropout Criteria:
- Pregnancy
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2017
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02219113
Start Date
July 1 2014
End Date
April 1 2017
Last Update
July 21 2017
Active Locations (1)
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1
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, Russia, 121359