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:

• Adults aged 18 to 70 years old at the time of screening.
• People diagnosed with symptomatic patellofemoral osteoarthritis (a type of knee joint problem involving the kneecap area) graded 1–4 on the Iwano Classification scale (confirm with trial site).
• People with moderate to severe cartilage damage (Grade 3–4 on the ICRS scale) on the kneecap, the groove at the end of the thigh bone, or both (confirm with trial site).
• People whose knee function score is below 75 on a standard knee assessment questionnaire called the KOOS-5.
• People whose affected knee either moves freely or has very limited restriction — no more than 5° loss of straightening and at least 125° of bending ability.
• People who are willing and able to sign a consent form, attend all follow-up appointments, complete all study assessments, and follow the post-surgery rehabilitation programme.
• Women with blood test results meeting minimum levels: haemoglobin 120g/l, platelets 150G/l, and a clotting measure (INR) below 1.3.
• Men with blood test results meeting minimum levels: haemoglobin 140g/l, platelets 150G/l, and a clotting measure (INR) below 1.3.
• People whose knee problems have not improved enough with non-drug treatments (such as structured exercise programmes) and first-line pain medications (such as anti-inflammatory creams or gels).

Who may not be able to join:

• People who are directly involved in running this study, or who are a close relative of someone who is, or who have an employment or dependent relationship with the study sponsor.
• People who are unwilling, unable, or do not have the capacity to give informed consent.
• 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 washout of the joint within 12 months may still be acceptable — confirm with trial site).
• People who have signs of joint disease in the main part of the knee joint (between the thigh bone and shin bone), as seen on X-ray or MRI, or who have pain in that part of the knee during a physical examination.
• People with a significant inward or outward bowing of the knee (more than 5°), unless this can be corrected during the procedure.
• People with a painful meniscus injury (the cartilage cushions inside the knee) or where more than half of a meniscus has been removed, as confirmed by physical examination and MRI.
• People with a body mass index (BMI) above 35 kg/m².
• People with chronic rheumatoid arthritis or joint infection (infectious arthritis).
• People with another painful or disabling condition affecting the spine, hips, or legs that would make it difficult to properly assess the knee.
• People with a known condition that weakens the immune system, or who are taking medication that suppresses the immune system.
• People who have had any injection into the affected knee joint within the 3 months before their baseline visit.
• People with instability in the knee ligaments (front, back, or side ligaments).
• People with an HIV/AIDS infection.
• People with an active syphilis infection.
• People with an active hepatitis B or C infection confirmed by certain blood markers (people who have recovered from hepatitis B or C and have confirmed antibodies are not excluded).
• People who are pregnant, breastfeeding, or planning to become pregnant within 24 months after surgery.
• People who are currently taking part in, or have taken part in, another clinical study within the 3 months before screening.
• People with a known current or recent history of alcohol or drug misuse or dependence, defined as continued use despite social, legal, or health problems arising from it.
• People with any other condition that the study doctor considers would make participation unsuitable.
• People with a known allergy to pig (porcine) collagen, penicillin, or streptomycin.
• People with a condition called Nail-Patella syndrome.
• People who are likely to benefit from continuing conservative (non-surgical) treatments such as physiotherapy, exercise therapy, or pain medication.
• People with increased risks related to anaesthesia or surgery (for example, a known or anticipated difficult airway, or a heart attack within the 60 days before surgery).
• People with increased bleeding risk, such as a blood clotting disorder.
• People taking blood-thinning medication that cannot be safely paused as required before and during the procedure.
• People with any active infection at the time of joining the study.

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