Phase 3 Osteoarthritis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People aged 20 to 79 years old at the time of signing consent forms
• People who have been diagnosed with knee osteoarthritis rated at a specific severity level (Kellgren-Lawrence Grade 2 to 4) based on a knee X-ray
• People whose knee condition is suitable for a type of bone surgery called proximal tibial osteotomy, meaning the knee can bend to at least 120 degrees and straighten to within 5 degrees of fully straight
• People who have cartilage damage on certain parts of the knee joint, where each damaged area is at least 4 cm² in size
• People with multiple areas of cartilage damage where the total damaged area is no larger than 21 cm²
• People with a Body Mass Index (a measure of body weight relative to height) below 30
• People who do not have ligament injuries or significant meniscus (cartilage cushion) injuries in the target knee that require surgical repair beyond minor removal
• People with no history of certain previous knee procedures in the target knee, including ligament reconstruction, meniscus stitching, full meniscus removal, bone marrow stimulation, or treatment with regenerative medicine, cell, or gene therapy products
• People who have not received hyaluronic acid injections or strong (opioid) pain medications in the target knee within the past month
• People who have not received steroid injections or immune-suppressing medications in the target knee within the past 3 months
• People who have not had platelet-rich plasma (PRP) therapy within the past 6 months
• People who are non-smokers, or smokers who agree to stop smoking from 3 months before surgery until the bone has healed after the operation
• People who give written voluntary agreement to take part in the study

Who may not be able to join:

• People who need surgery on the other (non-study) knee during the trial period
• People with other health conditions that could interfere with having surgery under general anaesthetic or that could affect knee surgery
• People with a whole-body inflammatory condition such as rheumatoid arthritis
• People with an active infection anywhere in the body, such as a bacterial, fungal, or viral infection
• People with serious conditions affecting the liver, kidneys, heart, lungs, blood, or metabolism, if the trial doctor considers these to make the person unsuitable
• People who have been diagnosed with or are suspected of having cancer, or who have had cancer within the past 5 years
• People with an uncontrolled mental health condition
• People with poorly controlled diabetes (indicated by a blood sugar marker called HbA1c above 7.0%)
• People with a current joint infection (septic arthritis) in the target knee
• Women who are pregnant, breastfeeding, or who could become pregnant — unless strict contraception requirements set by the trial (using methods approved in Japan) are met (confirm with trial site for full details)
• People who have taken part in another clinical trial within the past 6 months, are currently in another trial, or plan to join another trial at the same time
• People with a known allergy to certain antibiotics (benzylpenicillin potassium, streptomycin sulfate, or amphotericin B)
• People with a known allergy to products derived from cattle
• People the trial doctor considers unsuitable for any other reason

Important: Always verify eligibility with the trial site directly before applying.