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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
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.
Aarhus University
Aarhus N, Denmark
RECRUITINGObservation (change) of adverse events
Pain Diary first 30 days after treatment, any reported adverse events after treatment
Time frame: Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years
Change in Knee symptoms (questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms)) from baseline
(questionnaire Knee injury and Osteoarthritis Outcome Score (KOOS) (symptoms))
Time frame: Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years
Change in pain from baseline
Numeric Rating Scale (NRS)
Time frame: Baseline, 3 months, 12 months, 24 months, 3 years, 4 years, 5 years
Observation (change) of cartilage regeneration compared to baseline
MRI Osteoarthritis Knee Score
Time frame: Baseline, 3 months, 12 months, 24 months
Observation (change) of quantitative cartilage regeneration compared to baseline
Quantitative MRI (unit: stress and strain and volumen cartilage)
Time frame: Baseline, 3 months, 12 months, 24 months
Improvement (change) during clinical examination with range of motion compared to baseline
Range of motion (unit: degrees)
Time frame: Baseline, 3 months, 12 months, 24 months
Improvement (change) during clinical examination with Effusion tests (swelling) compared to baseline
Effusion tests (swelling) (unit: effusion (YES/NO))
Time frame: Baseline, 3 months, 12 months, 24 months
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Improvement (change) during clinical examination with measurement of knee diameter (swelling) compared to baseline
Measure knee diameter (unit: cm)
Time frame: Baseline, 3 months, 12 months, 24 months
Improvement (change) during clinical examination with measurement of quadriceps muscle diameter (atrofi) compared to baseline
Measure quadriceps muscle (unit: cm)
Time frame: Baseline, 3 months, 12 months, 24 months