ASCs will be administered via intra-articular use into the knee joint affected by OA where they are expected to exert their therapeutic effects. The objective of this clinical trial is to generate efficacy and tolerability profiles of single injections of 2 dosages of autologous ASCs versus standard of care (placebo), when administered locally into a knee joint affected by OA after in vitro cell expansion. The potential of ASC to lead to a disease-modifying therapeutic option for the treatment of this chronic and debilitating disease will be assessed by MRI after 1 and 2 years. This will be a phase IIb, multi-centre, prospective, randomized, double-blind study, comparing culture-expanded autologous ASC with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Injection of Autologous adipose derived stem cells (2x106 ASC/5ml). The patient of this group will receive one single administration of the cells and will be followed for 12 months. A final follow up visit will occur at Month 24.
Injection of Autologous adipose derived stem cells (10x106 ASC/5ml). The patient of this group will receive one single administration of the cells and will be followed for 12 months. A final follow up visit will occur at Month 24.
Injection of placebo 0.5% glucose in saline with 4.5% alb/5ml The patient of this group will receive one single administration and will be followed for 12 months. A final follow up visit will occur at Month 24.
UH Montpellier
Montpellier, France
Improvement of pain or physical function
evaluate the efficacy of ASC in mild to moderate knee OA (KL 2-3) based on increase in the number of "strict" responders defined by improvements from baseline in WOMAC pain or physical function subscores 50% with absolute changes 20 mm at 6 month, compared to placebo
Time frame: Month 6
Disability (WOMAC)
assessed by WOMAC questionnaire
Time frame: Months 1, 3, 6, 12 and 24
Disability (KOOS)
assessed by KOOS (Knee injury and Osteoarthritis Outcome Score questionnaire)
Time frame: Months 1, 3, 6, 12 and 24
Disability (SAS)
assessed by SAS questionnaire (The Short Arthritis Assessment Scale)
Time frame: Months 1, 3, 6, 12 and 24
Change in Quality of life
assessed by SF-36 questionnaire
Time frame: Months 1, 3, 6, 12 and 24
painkillers consumption
Changes from baseline (Day 0) to months 1, 3, 6, 12 and 24 in use of painkillers
Time frame: Months 1, 3, 6, 12 and 24
Structural changes (X-Ray)
Changes from baseline (Day 0) to months 12 and 24 in femorotibial joint space of the index knee on X-ray
Time frame: Months 12 and 24
Structural changes (MRI)
Changes from baseline (Day 0) to months 12 and 24 by MOAKS (MRI Osteoarthritis Knee score)
Time frame: Months 12 and 24
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