Cartilage Recovery in Adults With Knee Osteorthritis by Mesenchymal Cell Therapy: Randomized Trial of Radiologic and Clinical Outcomes (INMUNOCEM-OA)
Knee Osteoarthritis
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria: Pain most days for the last month. Presence of osteophytes. Synovial fluid with mechanical characteristics. Morning stiffness for less than 30 minutes in the affected joint. Patellar crepitus. Patients aged 40 years or older and less than 60 years. Radiological criteria for osteoarthritis of the knee Kellgren-Lawrence 2 to 4 in comparative radiographs with knee support taken in the last 12 months prior to consultation. Pain in one or both knees according to a visual analogue scale of 5 or more, out of 10 points in the last 3 months. Exclusion Criteria: Consumption of non-steroidal anti-inflammatory drugs or anticoagulants in the last 14 days. Patient with a history of joint infiltration or arthroscopic surgery of the affected knee in the last 6 months. Participants in another treatment or research study within the past year. Pregnant or lactating patients. Patient with active tumor pathology or a history of oncological disease. Patient with metabolic disease and/or uncontrolled coagulopathy at the assessment time. Patients who have received previous treatments such as microfractures, and osteochondral allografts. Patients with present meniscal lesions. Patients with a history of thyroiditis or thyroid nodules with increased antithyroglobulin antibodies. Patients with a history of osteoarticular infection in the last 5 years or active at the time of assessment.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
IMUNOCEM
PLASMALYTE
Administration of umbilical cord-derived mesenchymal stromal cells suspension
Administration of plasmalyte as vehicle for MSC