Anterior Cruciate Ligament Partial Rupture
Conditions
Keywords
Anterior cruciate ligament, Ligament rupture, Intraarticular injection, ADRC, Adipose-derived regenerative cells, Adipose tissue, Stem cells
Brief summary
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.
Detailed description
Patients with verified diagnosis partial rupture of anterior cruciate ligament will undergo liposuction from front abdominal wall under local anesthesia. After that autologous ADRC will be extracted using Celution 800/CRS System (Cytori Therapeutics Inc) from harvested adipose tissue. Same day patients will undergo knee arthroscopic surgery followed by one-time intraarticular freshly isolated ADRC administration (directly into anterior cruciate ligament close to the rupture).
Interventions
PROCEDURELiposuction
DEVICEADRC isolation
ADRC isolation performed using Celution 800/CRS System (Cytori Therapeutics Inc) according to manufacturer's protocol
PROCEDUREArthroscopic surgery
Sponsors
I.M. Sechenov First Moscow State Medical University
Central Clinical Hospital w/Outpatient Health Center of Business Administration for the President of Russian Federation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of serious adverse events (SAEs) and serious adverse reactions (SARs) | 2 weeks after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life monitoring | Follow up to completion (up to 24 weeks after treatment) | Quality of life estimated by validated questionnaires: the Short Form (36) Health Survey (SF-36), Knee Injury and Osteoarthritis Outcome Score (KOOS) |
| Knee pain intensity monitoring | Follow up to completion (up to 24 weeks after treatment) | Knee pain intensity assessed by Visual Analogue Scale (no pain=0; maximum pain=100 mm) |
| Changes in knee joint structures | Follow up to completion (up to 24 weeks after treatment) | Changes in knee joint structure assessed by: 1. X-ray (joint space width, bone contour, presence of osteophytes and sclerosis); 2. MRI (articular cartilage, osteophytes, bone marrow abnormality, meniscal integrity, synovial effusion/tissue, anterior and posterior cruciate ligaments, and medial and lateral collateral ligaments); 3. Ultrasonography (effusion, synovial thickening or hypertrophy, cartilage parameters, vascularity, Baker's cysts, osteophytes, tendon and ligament abnormalities, meniscal changes, bursitis, erosions and panniculitis) |
| Changes in knee function | Follow up to completion (up to 24 weeks after treatment) | Changes in knee function assessed by questionnaire: Knee Society Score (KSS) |
Countries
Russia
Outcome results
None listed