Phase 3 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 knee osteoarthritis according to specific Chinese Medical Association guidelines.
• People who have had ongoing knee pain for more than six months, or whose knee osteoarthritis has come back or gotten worse after stopping common treatments such as steroid injections, opioid painkillers, anti-inflammatory drugs, or joint fluid replacement therapy.
• People whose study knee shows a moderate level of joint damage (Kellgren-Lawrence grade II or III on imaging), and whose other knee shows mild or less damage (grade II or below).
• People whose total WOMAC score (a standard measure of osteoarthritis symptoms) falls between 50 and 150 at the screening visit (confirm with trial site).
• People whose pain level in the study knee is rated at least 50 out of 100 on a pain scale at the screening visit.
• People aged between 40 and 80 years, of any gender, with a Body Mass Index (BMI — a measure based on height and weight) of 30 or below.
• People who are able to understand the trial, sign a consent form voluntarily, and are willing to attend all trial visits and follow-up appointments.

Who may not be able to join:

• People whose knee osteoarthritis is caused by another underlying condition (called secondary osteoarthritis).
• People who have other conditions affecting their knee joint, such as recent injury, rheumatoid arthritis, gout, psoriatic arthritis, bone disease, joint infections, or reduced blood flow in the legs, among others.
• People whose knee has a significant inward or outward bowing deformity (greater than 15 degrees) or a significant inability to fully straighten the knee.
• People who have previously received stem cell therapy.
• People who have taken opioid painkillers, anti-inflammatory pain medicines, or any other pain relief medication for knee osteoarthritis within 2 weeks (or longer, depending on the specific medicine) before starting treatment.
• People who have received physiotherapy or traditional Chinese medicine treatment for knee arthritis within 6 weeks before starting treatment.
• People who have had steroid injections into or around the knee, or have taken steroid medicines throughout the body, within 12 weeks before starting treatment, or who will need to take systemic steroids during the trial.
• People who started taking glucosamine, chondroitin sulfate, or diacerein (joint supplements or related medicines) within 4 weeks before treatment — unless they have been taking glucosamine or chondroitin sulfate consistently for longer and are willing to keep the same dose throughout the trial.
• People who have had any injection treatment into either knee joint within 6 months before starting treatment.
• People who have had major surgery, joint replacement, or keyhole surgery on the study knee within 24 weeks before signing the consent form, or who plan to have surgery on that knee during the trial.
• People who have had any surgery on the hip or knee within 12 weeks before signing the consent form.
• People whose study knee cannot safely undergo an MRI scan, such as those with certain metal implants in their body.
• People who plan to have any lower limb surgery within 48 weeks of signing the consent form.
• People who have a skin condition or skin infection near the planned injection site.
• People who have osteoarthritis in the opposite knee and plan to receive injection treatment into that knee during the trial.
• People who have a hip joint problem on the same side as the study knee that requires medical treatment.
• People who have had an allergic reaction to any ingredient in the trial medication.
• People who currently have cancer, or who have had cancer within the past 5 years before signing the consent form.
• People who have a known history of mental health disorders, or a history of misusing psychiatric drugs or other substances.
• People with serious heart disease, significantly abnormal liver function, significantly abnormal kidney function, blood clotting problems, or serious blood disorders — based on specific laboratory test results (confirm with trial site for exact thresholds).
• People with certain active or chronic viral infections, including a specific form of hepatitis B, hepatitis C, HIV, or syphilis.
• People who are pregnant or breastfeeding, or people (of any gender) who are unwilling to use contraception from the time of enrolment until 6 months after their last trial visit.
• People who have taken part in another clinical trial within 3 months before signing the consent form.
• People considered unsuitable for the trial by the trial investigator for any other reason.

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