Active knee Osteoarthritis (mild to moderate)
Conditions
Interventions
Product Name: Autologous adipose derived stromal
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Suspension for injection
Route of administration of the placebo: Intr
Sponsors
CHU Montpellier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Symptomatic mild to moderate osteoarthritis (OA) of the index knee as defined by the American college of Rheumatology (ACR): - History of pain in the index knee = 6 months, AND - Kellgren-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 2. Must meet the following pain criteria at the time of screening/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 Analogic 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 =65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1. Previous treatments acting on cartilage or bone metabolism (eg, oral or intravenous bisphosphonates <1 year previously, strontium ranelate or teriparatide or raloxifene <7 days prior to selection, and oral glucosamine =1500 mg/day and chondroitin sulphate <3 months previously) 2. Prior to the screening visit, has received intra-articular injection of corticosteroids, platelet rich plasma or hyaluronic acid within the previous 6 months, 3. Significant trauma or surgery to the index knee within the last year or arthroscopy of the index knee within 12 months of screening. 4. Kellgren-Lawrence Grade 1 or 4 in the index knee. 5. Osteoarthritis causing significant pain in any joint other than the identified knee, i.e., pain in hip, back, or contralateral knee (= 20 mm pain) as confirmed by a separate VAS at baseline for any other painful joint concerned 6. History of joint replacement of the knee or hip within the ?previous 12 month 7. Diagnosis of one or more of the following: - Inflammatory arthritis such as rheumatoid arthritis, autoimmune disorder, seronegative spondyloarthritis, gout or pseudogout (defined as acute episodic attacks of swollen, painful joint in a patient with X-Ray chondrocalcinosis or CPPD crystals); - Severe misalignment of the knee (excessive varus or valgus = 8°) at physical examination, as confirmed by standard radiograph - Severe osteoporosis with previous fractures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of a single intra-articular injection of 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 (vehic: 0.5% glucose in saline with 4% alb);Secondary Objective: - Kellgren-Lawrence scores assessment on the basis of X-rays - Progression of affected knee joints by quantitative MRI - Disability and life quality assessment - OARSI response assessment - Paracetamol (Acetaminophen) medication assessment;Primary end point(s): 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.;Timepoint(s) of evaluation of this end point: Month 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 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;Timepoint(s) of evaluation of this end point: Months 1, 3, 6, 12 and 24 | — |
Countries
Germany, Netherlands
Contacts
Public ContactChristian JORGENSEN
CHU Montpellier
Outcome results
None listed