Status:
COMPLETED
Study on Knee Osteoarthritis
Lead Sponsor:
Symatese
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
35-85 years
Phase:
NA
Brief Summary
Osteoarthritis (OA) is a chronic degenerative joint disease characterized macroscopically by progressive damage of articular cartilage, joint space narrowing, subchondral bone remodelling, joint margi...
Detailed Description
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 2 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 16 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06097988
Start Date
February 2 2024
End Date
September 16 2024
Last Update
November 19 2024
Active Locations (2)
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1
Knohenfelds
Riga, Rīga, Latvia, 1039
2
KRASTINS
Riga, Rīga, Latvia, 1050