Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy

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

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

Conditions2

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