damaged cartilage Knee arthrosis
Conditions
Interventions
None listed
Sponsors
CHRU Montpellier
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1) Male or female between the ages of 45 and 70, during screening. 2) BMI between 20 and 35 kg/m2 3) Symptomatic mild to moderate osteoarthritis (OA) of the index knee as defined at baseline by the American college of Rheumatology (ACR): -History of pain in the index knee * 6 months, AND -Kellgren and Lawrence (K-L) Grade 2 or 3 only, on plain radiographs of the index knee (including fixed flexion), AND -Swelling of the index knee evaluated by the investigator 4) Must meet the following pain criteria at the time of baseline visit since at least half of the days in the previous month: -Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscores * 40 mm on the 0-100 normalised scale -Visual analogis scale (VAS) pain rating of at least 40 on a 100-mm scale -Subject*s global assessment of arthritis status must be fair, poor, or very poor -Subject*s global assessment of the contralateral knee
Exclusion criteria
Exclusion criteria: 1) Previous treatments acting on cartilage or bone metabolism (eg, oral or intravenous bisphosphonates
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Efficacy Analysis: * Improvement from baseline to month 6 in WOMAC pain score of the index knee. * Improvement from baseline to month 6 in WOMAC physical function score of the index knee. The main objective is to evaluate the efficacy of a single intra-articular injection of ASC (either 2.106 or 10.106 ASC) in mild to moderate knee OA (KL 2-3) based on improvement of WOMAC pain and function subscore at 6 month, compared to placebo (vehicle: 0.5% glucose in saline with 4,5% human albumin).. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary efficacy analysis: * Changes from baseline to months 1, 3, 6, 12 and 24 in OARSI scores of the index knee. * Changes from baseline to months 1, 3, 6, 12 and 24 in VAS pain scores of the index knee. * Changes from baseline to months 1, 3, 6, 12 and 24 in WOMAC stiffness scores of the index knee * Changes from baseline to months 1, 3, 6, 12 and 24 in WOMAC global scores of the index knee * Changes from baseline to months 1, 3, 12 and 24 in WOMAC pain and function scores of the index knee * Changes from baseline to months 1, 3, 6, 12 and 24 in KOOS scores of the index knee * Changes from baseline to months 1, 3, 6, 12 and 24 in SAS scores of the index knee * Changes from baseline to months 1, 3, 6, 12 and 24 in SF-36 * Changes from baseline to months 12 and 24 in cartilage volume/thickness of the index knee MRI (MOAKS score). * Changes from baseline to months 12 and 24 in femorotibial joint space of the index knee on X-ray Potential structural benefit - Kellgren-Lawrence scores will be assessed on the basis of X-rays (conventional standing antero-posterior radiograph with fixed location JSW). Joint space width will be measured at baseline, one-year and 2-years post-injection as previously described (Kothari M, Guermazi A, von Ingersleben G, et al. Fixed-flexion radiography of the knee provides reproducible joint space width measurements in osteoarthritis. Eur Radiol 2004;14:1568*73). Concerning the X ray, a standardize procedure will be approved. We propose semiflexion and lateral view of knee joint, with similar distance and position at one year. For this, a device will be used. Joint space narrowing less than 0.5 mm will be considered as significant. - Progression of affected knee joints by quantitative MRI will include volumetric measurement (cartilage volume, thickness, surface area, 3D shape) on T1 PDw FSE fat sat at baseline, months 12 and 24. Progression of affected knee joints by quantitative MRI will include volumetr | — |
Countries
Netherlands
Outcome results
None listed