Phase 1 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 who are willing and able to give their informed consent to take part
• Men or women aged 40 years or older
• People who have osteoarthritis (a type of joint wear and tear) in the inner part of the knee joint, confirmed by both knee pain and X-ray findings showing a specific level of joint damage (rated Grade 2 or 3 on a standard medical scale, with a minimum amount of joint space still remaining)
• People who rate their knee pain at 3 or more out of 10 on a pain scale at the screening appointment

Who may not be able to join:

• People whose knee X-ray shows either very early or very severe joint damage (rated Grade 0, 1, or 4 on the standard medical scale — including those with no damage at all, or those with "bone-on-bone" contact)
• People whose knee is significantly out of alignment (more than 10 degrees inward or outward)
• People whose knee osteoarthritis was caused by another specific medical condition, such as rheumatoid arthritis, gout, haemophilia, a previous infection, injury, or a number of other underlying diseases
• People who have taken part in another clinical trial or received an experimental treatment within the 3 months before screening (or within a longer period depending on the treatment used)
• People who are currently taking corticosteroids (steroid tablets or similar medicines) or immune-suppressing medications such as cyclosporine
• People who have had a steroid or hyaluronic acid injection into the affected knee joint within the 3 months before the start of the trial
• People who have planned major surgery, such as a joint replacement, within 2 months after the trial injection
• People who have previously had any surgery on the knee being studied, including keyhole (arthroscopic) surgery
• People who have skin problems at the planned injection site, such as open wounds, psoriasis lesions, or skin infections
• People who have any known active infection
• People with significantly abnormal blood test results related to blood cell counts, liver function, kidney function, or blood clotting at the screening appointment
• People who test positive for HTLV, HIV, Hepatitis B, or Hepatitis C
• People who are known to be allergic to any ingredient in the trial treatment
• People with a history of sarcoma (a type of cancer affecting bones or soft tissue)
• People who have had any cancer diagnosis within the past five years (with the exception of certain treated skin cancers)
• Women who are still able to become pregnant (i.e., not yet post-menopausal) — (confirm with trial site for exact definition used)
• Women who are pregnant or breastfeeding
• People who are currently misusing drugs or alcohol
• People who are unable to have a contrast MRI scan of the knee, for reasons such as metal implants in the body, claustrophobia, a previous severe reaction to the contrast dye used, significantly reduced kidney function, or rapidly worsening kidney health — or people who are unwilling to have an MRI
• People whose X-ray or MRI shows other specific bone or joint problems, such as fractures, bone tumours, osteonecrosis (bone tissue death), certain types of meniscal tears, rheumatoid arthritis, or gout
• People who, in the opinion of the trial doctors, are unlikely to be able to follow the trial procedures or would be unsuitable for another reason

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