Primary: To study the safety of a single injection of autologous adipose derived mesenchymal stromal cells (ASCs) on patients with moderate or severe osteoarthritis of the knee (OA). Secondary: To study the efficacy of a single injection of autologous adipose derived mesenchymal stromal cells on patients with moderate or severe osteoarthritis of the knee (OA).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues.
Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues. The first patient will be followed during 12 weeks before inclusion of the second patient.
UH Montpellier
Montpellier, France
Orthopädische Klinik
Würzburg, Germany
Recording of Serious Adverse Events
Adverse events will be described with respect to seriousness, intensity, relationship to treatment, action taken and outcome of the adverse event.
Time frame: during 365 days following injection
Functional status of the knee
Efficacy will be assessed by measuring: * WOMAC (Western Ontario and McMaster Universities osteoarthritis index), * Short Arthritis assessment Scale (SAS), * range of motion of the target knee joint, * imaging through MRI evaluation, dGEMRIC and T1rho MRI.
Time frame: during 365 days following injection
Evaluation of Quality of life
Quality of life will be assessed by measuring: * pain-specific assessment * global patient assessment (visual analog scale, Short-Form 8) * decrease in rescue paracetamol medication.
Time frame: during 365 days following injection
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