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:

• A person must give written consent before any assessments take place
• The person must be able to communicate clearly with researchers and follow the study requirements throughout
• The person must be between 50 and 70 years old (inclusive), of any gender
• Men must weigh at least 50 kg and women at least 45 kg, and the person's body mass index (BMI) must be between 18 and 26 kg/m²
• The person must have been diagnosed with knee osteoarthritis (a condition where the knee joint wears down over time) according to specific 2018 Chinese clinical guidelines, and must have had this condition for more than 4 weeks
• An X-ray of the affected knee must show a moderate level of joint damage, rated Grade II or III on a standard medical scale (called Kellgren-Lawrence grading); if both knees are affected, the second knee must be no worse than the main knee being studied
• An MRI scan must show damage to the cartilage in the knee joint, either partial or complete
• The person's knee pain, measured on a standard 0–10 scale, must score between 5 and 7 at least 48 hours after stopping all pain-relieving medications during the screening period
• If the person currently uses paracetamol/acetaminophen for knee pain, they must agree to stop taking it at least 2 weeks before the study treatment starts (only certain anti-inflammatory medications would be allowed as a backup during the trial)
• If the person currently uses glucosamine, chondroitin, opioid-based painkillers, or similar supplements, they must agree to stop these at least 2 weeks before treatment begins

Who may not be able to join:

• People who have had a knee joint infection, surgery, or radiation treatment within the past 6 months
• People whose knee joint is unstable due to ligament damage, rupture, looseness, or a structural deformity of the knee
• People who have other conditions affecting the lower body — such as significant back pain, a slipped disc, or hip joint pain — that researchers believe could interfere with assessing how the knee is working
• People who have other local joint conditions that could be confused with knee osteoarthritis, including joint infection, reactive arthritis, recurring pseudogout, calcium deposits in the cartilage, or a joint fracture
• People who have had any injection treatment (such as growth factors, steroids, or hyaluronic acid) or a joint washout procedure in the affected knee within the past 3 months
• People who have tumours inside or around the knee joint
• People with serious ongoing health conditions, including significant neurological, breathing, or heart problems; liver, kidney, or blood clotting problems; or severe blood disorders — based on specific laboratory test results (confirm with trial site)
• People diagnosed with inflammatory or autoimmune joint diseases such as rheumatoid arthritis, psoriatic arthritis, gout, lupus, or similar conditions
• People who have taken oral corticosteroid (steroid) tablets at a dose above 5 mg per day for more than 14 days within the past 3 months, or who would need long-term steroid treatment during the trial
• People who have previously received stem cell therapy
• People with uncontrolled high blood pressure, defined as a reading above 160/100 mmHg at screening
• People with a history of cancer, serious mental illness, severe autoimmune disease, blood disorders, or long-term use of immune-suppressing medications
• People with a history of alcohol or drug abuse
• People with a known allergic reaction to protein-based medications
• People who are unable to have an MRI scan, or who are unwilling to undergo one
• People who test positive for hepatitis B, hepatitis C, HIV/AIDS, or syphilis
• Women who are pregnant or breastfeeding; people who tested positive on a pregnancy blood test during screening; or people of any gender planning to have a child within 3 months after treatment
• People who have received a live or weakened live vaccine within one month before the study treatment
• People who have taken part in another clinical drug or device trial within the past 3 months
• People who are unlikely to attend follow-up appointments or complete the full study
• People whom the researchers determine are not suitable for the trial for any other reason

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