Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy
Allogenic Mesenchymal Stem Cell Intraarticular Injection for Knee Osteoarthritis Therapy, an RCT Explorative Mode-of-action Study
Aarhus University Hospital
80 participants
Mar 7, 2024
INTERVENTIONAL
Conditions
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 Criteria7
- 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 Criteria14
- 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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Interventions
Laboratory isolated, cultivated and cryopreserved allogenic adipose derived mesenchymal stem cells (AD-MSC) from health donors undergoing cometic plastic surgery will be thawed on the injection day and formulated in 10 mL saline. The AD-MSCs will then be intraarticular injected using ultrasonic guidance.
10 mL saline will be intraarticular injected using ultrasonic guidance.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05933434