Phase 1 Osteoarthritis Trial, Recruiting

Written by an AI model from the 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 have been diagnosed with moderate knee osteoarthritis.
• People whose knee has been graded as Kellgren-Lawrence grade 2 or 3 (a standard scale used to measure the severity of knee osteoarthritis — confirm with trial site if unsure what grade applies).
• People whose Body Mass Index (BMI) is between 18.0 and 35.0 kg/m².
• People who have low levels of certain antibodies in their blood related to the treatment being studied (the trial site will check this).
• People who have already tried standard medications for knee arthritis, whose symptoms returned or worsened after stopping those medications, and who still have moderate pain — with a pain score of 8 or higher on a standard knee pain questionnaire during the screening period.
• People who agree not to try to have children, and agree not to donate sperm or eggs, from the time of screening until 52 weeks after receiving the study treatment, and who will use effective contraception during this time.
• People who are willing to sign a consent form and are able to follow all the steps required by the trial.

Who may not be able to join:

• People whose knee problems may be caused by something other than osteoarthritis, or who have other conditions that researchers think could be contributing to knee joint inflammation.
• People who have a history of a slipped disc in the lower back that causes nerve symptoms in the legs, which could interfere with study assessments.
• People who are unable or unwilling to have an MRI scan, or who have a medical reason that prevents them from having one.
• People who are unable or unwilling to have fluid removed from their knee joint as part of the study.
• People whose blood test results during the screening period show values that researchers consider could pose a health risk during the trial.
• People who test positive for Hepatitis B, Hepatitis C, HIV, or syphilis.
• People who are currently receiving treatment for Hepatitis B or Hepatitis C.
• People who have had an ongoing or active infection in the four weeks before joining the study.
• People who have a blood clotting disorder (such as haemophilia) or who need to take blood-thinning medication in a way that would make a knee injection unsafe.
• People who have, or have previously had, cancer or a malignant tumour.
• People who have previously received gene therapy or stem cell therapy, or who plan to receive either during the study period.
• People who have received any vaccine in the 30 days before the study treatment, or who have a vaccine scheduled within 30 days after the study treatment.
• People who are pregnant, breastfeeding, have a positive pregnancy test during screening, or plan to become pregnant within 52 weeks.
• People with a history of alcohol addiction or drug dependence, or who are unable to limit alcohol use during the study.
• People who have a mental health condition that could affect study assessments.
• People whom the trial investigators consider unsuitable for the study for any other reason.

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