Phase 2 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 18 to 65 years old at the time of screening.
• People who have been diagnosed with patellofemoral osteoarthritis (a type of knee joint wear affecting the kneecap area) rated as grade 1 to 3 on the Iwano Classification scale.
• People who have cartilage damage rated as grade 3 or 4 on the ICRS scale, affecting the kneecap, the groove at the end of the thigh bone, or both.
• People whose knee pain score is below 60 on a standard knee evaluation questionnaire called the KOOS Pain scale.
• People whose affected knee can move fairly freely — either with full range of motion, or with no more than 5 degrees of straightening loss and at least 125 degrees of bending ability.
• People who are willing and able to sign a consent form, attend all follow-up appointments, and complete the required post-surgery rehabilitation programme.
• Women with blood test results meeting minimum levels: haemoglobin at least 120 g/l, platelets at least 150 G/l, and an INR below 1.3.
• Men with blood test results meeting minimum levels: haemoglobin at least 140 g/l, platelets at least 150 G/l, and an INR below 1.3.
• People who have already tried all standard non-surgical treatments for their knee condition, except for PRP (platelet-rich plasma) injections.

Who may not be able to join:

• People who are directly involved in running this trial, or who are close relatives of those involved, or who have an employment or dependency relationship with the trial sponsor.
• People who are unable to understand the patient information provided for this study.
• People who are unable to have an MRI scan.
• People who have had surgery on the affected knee within the past 12 months (note: a previous diagnostic keyhole procedure with cleaning and rinsing of the joint within 12 months may still be acceptable — confirm with trial site).
• People who have signs of joint disease in the larger part of the knee joint (the tibiofemoral joint, between the thigh bone and shin bone), as seen on X-ray or MRI, or who have pain in that area on physical examination.
• People whose knee has a significant inward or outward angle of more than 5 degrees.
• People who have had a kneecap dislocation in the affected knee within the past 2 years.
• People who have a symptomatic meniscus injury (or who have had more than half of the meniscus removed), as confirmed by physical examination and MRI.
• People with a body mass index (BMI) above 35 kg/m².
• People who have chronic rheumatoid arthritis or infectious arthritis.
• People who have another painful or disabling condition of the spine, hips, or lower limbs that could affect the assessment of the knee.
• People who have a condition that weakens the immune system, or who are taking medications that suppress the immune system.
• People who have had any injection into the affected knee joint within the 3 months before the baseline visit.
• People who have instability of the ligaments at the front or back of the knee.
• People who have an HIV/AIDS infection.
• People who have an active syphilis infection.
• People who have an active hepatitis B or C infection with confirmed active virus markers (people with a past, fully resolved hepatitis B or C infection and confirmed antibodies are not excluded).
• People who are pregnant, breastfeeding, or planning to become pregnant within 24 months after surgery.
• People who are currently in, or have participated in, another clinical trial within the 3 months before screening.
• People with a known current or recent history of alcohol or drug misuse or dependence.
• People whom the trial investigator considers unsuitable for the study for any other reason.
• People with known allergies to porcine (pig-derived) collagen, penicillin, or streptomycin.
• People considered to have increased risks related to anaesthesia or surgery — for example, those with a known or expected difficult airway, or those who have had a heart attack within the past 60 days.
• People with conditions that increase the risk of bleeding, such as clotting disorders.
• People taking blood-thinning medications whose treatment cannot be safely paused as needed for surgery.
• People who have any active infection.

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