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Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy

RecruitingPhase 1, Phase 2Ages 40 Years - 75 YearsAllAarhus University Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 operations (more than one resection) * Diabetes mellitus type 1 and 2 * Knee instability on physical examination * History of allergy to antibiotics * Concomitant severe infection, malignant tumor, coagulation diseases or uncontrolled or unmanaged systemic disease * Presence of other types of inflammatory arthritis
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What it tests

  • Allogenic adipose derived mesenchymal stem cells (AD-MSC)
  • Saline
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Where

1 site
Aarhus University
Aarhus N, Denmark
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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