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 19 years or older
• People who have been diagnosed with osteoarthritis in one or both knees, based on specific medical criteria that include at least 3 of these 6 features: being aged 50 or older, morning stiffness lasting less than 30 minutes, a crackling or grating sensation in the knee during movement, tenderness in the bony areas of the knee, bony enlargement around the knee, or no noticeable warmth around the joint
• People who have had an X-ray within the last 6 months (or at the screening visit) showing a mild to moderate level of knee osteoarthritis (rated as grade I, II, or III on a standard medical scale)
• People who rate their knee pain during weight-bearing activities (such as standing or walking) at 40 mm or more on a 100 mm pain scale, in at least one knee
• People who can walk without a walking aid, or who have been regularly using the same walking aid for at least the past 6 months and are able to continue using it throughout the study
• People who are able to understand and fill in questionnaires about their symptoms and how they are feeling
• People who are willing and able to sign a written consent form agreeing to take part

Who may not be able to join:

• People with a Body Mass Index (BMI) of 32 or above (confirm with trial site)
• People with a long-term inflammatory joint condition such as rheumatoid arthritis
• People with an active joint infection such as septic arthritis
• People whose knee osteoarthritis is caused by certain underlying conditions such as ochronosis, hemochromatosis, or other systemic diseases
• People with other painful musculoskeletal conditions such as Sudeck's atrophy, Paget's disease, or a herniated spinal disc
• People who have severe osteoarthritis in several other joints (such as the hip) that could make it difficult to assess knee pain accurately
• People whose X-ray shows a clear loss of space in the kneecap joint (patellofemoral joint)
• People with moderate to severe fluid build-up in the knee joint, confirmed by a specific physical test
• People with a history of heart attack, heart failure, other serious heart conditions, or high blood pressure that remains uncontrolled despite being treated with three or more blood pressure medications
• People with a history of an autoimmune disease
• People with an active infection currently being treated with antibiotics given by injection or drip
• People with a history of a psychiatric disorder or epilepsy
• People who have been diagnosed with cancer within the past 5 years
• People with poorly controlled diabetes (type 1 or type 2), based on a specific blood test result (HbA1c above 7%)
• People who have had surgery (including keyhole surgery) on the knee being studied within the past year, or surgery on the other knee or hip that could affect the assessment of the study knee
• People who have had a steroid injection directly into the study knee within the past 12 weeks
• People who have taken steroid tablets or injections throughout the body within the past 4 weeks (steroid creams or inhalers are generally permitted)
• People who have had surgery or radiation treatment on the knee within the past 12 weeks, or who have not fully recovered from the side effects of such treatment
• People who have taken immune-suppressing medications (such as Cyclosporine A or Azathioprine) within the past 6 weeks
• People who have had any injection into the knee joint (such as hyaluronic acid) within the past 6 months
• People taking certain medications that have not been cleared from the body for long enough before the trial begins (confirm with trial site)
• People taking blood-thinning medications such as warfarin, newer anticoagulants, or clot-dissolving drugs, or antiplatelet agents such as aspirin above 100 mg per day or clopidogrel, or high-dose Vitamin E (above 1000 IU per day), within the past 2 weeks — note that low-dose aspirin at or below 100 mg per day is generally permitted
• People who have regularly used (for 3 months or more) medications that affect mood, thinking, or pain perception, such as psychoactive drugs or strong narcotic pain relievers
• People who have previously received cell therapy or gene therapy in the knee being studied, or who are planning to receive such treatments during the study
• People with certain abnormal blood test results at screening, specifically liver enzyme levels (ALT or AST), kidney function markers (BUN or serum creatinine) that are more than twice the normal upper limit
• People who regularly participate in high-intensity aerobic exercise or heavy strength training that places significant strain on the knee
• People with a skin condition at the injection site, or whose injection site is considered unsuitable by the medical team
• People with significant knee ligament instability rated at Grade II or higher (meaning the joint moves 5 mm or more beyond normal range)
• People with a known allergy or sensitivity to the study treatment or any of its ingredients
• Women who are pregnant or breastfeeding
• Women or men who are able to have children but are unwilling to use an accepted form of contraception throughout the study — accepted methods include an intrauterine device (IUD), tubal ligation, sterilisation surgery, a condom or diaphragm used with spermicide, or natural family planning
• People who have taken part in another clinical trial within the past 4 weeks
• People with cognitive impairment or dementia that would prevent them from giving informed consent
• People who the trial medical team consider unsuitable for any other reason

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