Knee Joint Osteoarthritis Clinical Trial
Official title:
Effectiveness and Safety of Intraarticular Administration of Autologous Adipose-Derived Regenerative Cells for Treatment of Degenerative Damage of Knee Articular Cartilage
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 will be administered one-time intraarticularly. This is a single arm study with no control. All patients receive cell therapy.
| Status | Completed |
| Enrollment | 12 |
| Est. completion date | April 2017 |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years to 85 Years |
| Eligibility |
Inclusion Criteria: - 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 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 Cockroft-Gault formula) - Confirmed syphilis, HIV, hepatitis B or C infections Dropout Criteria: - Pregnancy |
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Central Clinical Hospital with Outpatient Health Center of Business Administration for the President of Russian Federati | I.M. Sechenov First Moscow State Medical University |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of serious adverse events (SAEs) and serious adverse reactions (SARs) | Types, probability and severity of treatment emergent serious adverse events (SAEs) and serious adverse reactions (SARs) | 4 weeks after treatment | |
| Secondary | Quality of life monitoring | Quality of life estimated by validated questionnaires: the Short Form (36) Health Survey (SF-36), Knee Injury and Osteoarthritis Outcome Score (KOOS) | Follow up to completion (up to 24 weeks after treatment) | |
| Secondary | Knee pain intensity monitoring | Knee pain intensity assessed by Visual Analogue Scale (no pain=0; maximum pain=100 mm) | Follow up to completion (up to 24 weeks after treatment) | |
| Secondary | Changes in knee joint structures | Changes in knee joint structure assessed by: X-ray (joint space width, bone contour, presence of osteophytes and sclerosis); MRI (articular cartilage, osteophytes, bone marrow abnormality, meniscal integrity, synovial effusion/tissue, anterior and posterior cruciate ligaments, and medial and lateral collateral ligaments); 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) | |
| Secondary | Changes in knee function | Changes in knee function assessed by validated questionnaire: Knee Society Score (KSS) | Follow up to completion (up to 24 weeks after treatment) |