Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy
Trial Parameters
Brief Summary
This phase I and II double blinded randomized clinical controlled trial investigates the safety and efficacy of intraarticular knee injection with allogenic adipose derived mesenchymal stem cells (AD-MSC), in patients suffering from mild-moderate knee osteoarthritis compared to placebo injection with saline.
Eligibility Criteria
Inclusion Criteria: * Chronic knee pain (defined for at least 6 months with NRS 4 or above when pain worst) * Patients with Grade II-III osteoarthritis according to the Kellgren Lawrence Classification and a joint width space of 1-3 mm. * Axial hip, knee, ankle x-ray with no more than 5 degrees valgus/varus deformity * Medial, lateral or dual compartment OA as determined above * BMI \<35 * Danish speaker * Patients must be legally competent and must be able to sign the written consent Exclusion Criteria: * Severe Osteoarthritis (Grade IV according to Kellgren Lavrence Classification) * Intraarticular tumor, infection or fracture * Pregnancy and breast feeding * Cognitive impairment * Treatment with cytostatic drugs * Previous intraarticular knee injection in the past 3 mo. * Unable to perform MRI scan (non-compatible implants, claustrophobia and severe obesity(\>BMI 35) * Previous ligament reconstruction * Meniscal operation with resection with more than 50% or multiple meniscal operat