Study on Knee Osteoarthritis

The study is a pilot, prospective, multicenter, clinical trial that aims to evaluate the safety and efficacy of ABIO3419 for the treatment of knee osteoarthrosis.

Inclusion criteria

• Voluntarily given informed consent to investigation participation in writing encompassing consent to data recording and verification procedures.
• Male and female subjects, aged 35 to 85 years (inclusive).
• Subjects affected by knee osteoarthritis, as defined by American College of Rheumatology (ACR) clinical and radiographic criteria for osteoarthritis of the knee, and meeting the following conditions:

• Kellgren-Lawrence Grade 2 to 3 severity osteoarthritis of the knee confirmed by an extension face X-rays shot, supported by flexion face X-rays shot (optional) obtained within 6 months from the screening visit.
• Subjects suffering from osteoarthritis symptoms of the target knee for at least 6 months prior to the screening visit.
• Pain during walking on flat ground in the target knee of at least 40 mm and maximum 80 mm on a 0-100 mm Visual Analogic Scale at the baseline visit (Visit 2).
• Women of childbearing potential must have a negative urine pregnancy test prior to each injection.
• Subject who is able to comply with the study requirements, at the Investigator's appreciation.
• Subject being affiliated to a health social security system

Exclusion criteria

• Pregnant and breastfeeding women
• Subject with bilateral osteoarthritis of the knees is excluded if one of the following point is present on the non-targeted knee has:

• a visual analog scale score greater than 30mm (> 30mm),
• a Kellgren-Lawrence score is greater than 2 (>2)
• a dedicated antalgic consumption.
• Subject suffering from a severe or progressive disease or any other pathology which, according to the investigator, may interfere with evaluation of the results of the study: diabetes, autoimmune pathology, cardiac pathologies, hepatic deficiency, epilepsy, porphyria, rheumatoid arthritis or other systemic inflammatory process.
• Subject who has a known history of severe multiple allergies, angioedema or anaphylactic shock according to the investigator opinion.
• Subject with a known allergy or hypersensitivity to Hyaluronic Acid or bovine collagen.
• Subject with a past history of severe streptococcal disease or an active streptococcus infection according to the investigator opinion.
• Subject with a disorder that may impact wound healing such as connective tissue or immunosuppressive disorder.
• Subject having received chemotherapy agents, immunosuppressive medications within the past 3 months.
• Subject with bleeding disorders or subject received medication (anti-platelet agents and anticoagulant) that will likely increase the risk of bleeding within the past 24 hours before injections.
• Subjects having received:

• Intra-articular knee corticosteroids within 60 days prior to the baseline visit.
• Chondroitinsulphate, glucosamine sulphate, diacereine, bisphosphonates or matrix metalloproteinase inhibitors within 30 days prior to the baseline visit.
• Viscosupplementation of the target knee within 6 months prior to the baseline visit.
• Any kind of antalgic and Non-steroidal anti-inflammatory drugs in the 24 hours prior to the baseline visit (V2) and before each visit.
• Subjects with a Kellgren-Lawrence grade 4 femora-patellar osteoarthritis or subjects with a femora-patellar osteoarthritis Kellgren-Lawrence grade higher than the femora-tibial one.
• Subjects with coxarthrosis.
• Subjects having had any previous surgery in the target knee within 6 months prior to the screening visit, or any planned surgery in the target knee throughout the duration of the investigation.
• Subjects who have had arthroplasty at the target knee at any time.
• Subjects having had diagnostic or surgical knee arthroscopy, or knee lavage in the target knee in the 6 months prior to the screening visit.
• Subjects that are candidate for knee replacement within next 6 months.
• Subjects with body mass index > 35 kg/m2.
• Subjects with large intra-articular effusion of the target knee, venous or lymphatic stasis, inflammatory flare-up with various symptoms, local inflammation.
• Subjects with history of septic osteoarthritis of any joint
• Subjects with significant pain outside the target knee, including significant hip or back pain and with fibromyalgia.
• Subjects with clinically significant valgus/varus deformities, ligamentous laxity, or meniscal instability as assessed by the Investigator.
• Subjects with other musculoskeletal condition affecting the target knee that would impair assessment of the effectiveness in the target knee (e.g. Paget's disease of bone).
• Subjects with a current malignancy or having treatment for a malignancy, except non-melanoma skin cancer.
• Subjects with drug or alcohol abuse
• Subject who is deprived of their freedom by administrative or legal decision.
• Subject living in a social or sanitary establishment.
• Subject being in an exclusion period for a previous study or with a current or recent (<3 months) participation in another investigational study involving a drug or combined device with drug.
• Other condition preventing the subject to participate the study in the Investigator's opinion: subject deemed unreliable or incapable of understanding and complying with the study assessment or unrealistic expectations of treatment results.