Anterior Cruciate Ligament Partial Rupture Clinical Trial
Official title:
Effectiveness and Safety of Intraarticular Administration of Autologous Adipose-Derived Regenerative Cells for Treatment of Anterior Cruciate Ligament Partial Rupture
Autologous adipose-derived regenerative cells (ADRC) will be extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from a portion of the fat harvested from the patient's front abdominal wall. Patients will undergo knee arthroscopic surgery followed by one-time intraarticular ADRC administration (directly into anterior cruciate ligament). This is a single arm study with no control. All patients receive cell therapy.
| Status | Enrolling by invitation |
| Enrollment | 12 |
| Est. completion date | December 2018 |
| Est. primary completion date | June 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Patient suffers from partial rupture of anterior cruciate ligament (confirmed by MRI or knee arthroscopic surgery) - Clinically significant knee instability (positive anterior drawer test, pivot shift test, and Lachman test) - Patient is familiar with Participant information sheet - Patient signed informed consent form Non-inclusion Criteria: - Knee osteoarthritis grade III and grade IV - Medical history of autoimmune diseases - Patients prescribed for immunosuppressive treatment - Contraindications to the general or local anesthesia or medical history of allergic reactions to anesthetics - Subcompensated or decompensated forms of chronic diseases of internal organs - 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 - 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: - Complete anterior cruciate ligament rupture confirmed by knee arthroscopic surgery - 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) | 2 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 questionnaire: Knee Society Score (KSS) | Follow up to completion (up to 24 weeks after treatment) |