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NCT06163573
Treatment of Patellofemoral Osteoarthritis With Engineered Cartilage.
Conditions: Patellofemoral Osteoarthritis
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 75
Sponsor: University Hospital, Basel, Switzerland
Location: Poliklinika Ivković Zagreb
Summary
The purpose of this investigator-initiated study is to assess the efficacy of treating patellofemoral osteoarthritis with an Advanced Therapy Medicinal Product (ATMP), autologous nasal chondrocyte tissue engineered cartilage (N-TEC), in comparison with a standard therapy using platelet rich plasma injections.
The engineered cartilage graft is obtained by culturing expanded autologous nasal chondrocytes within a collagen type I/III membrane.
Eligibility Criteria
Inclusion Criteria:
* Patient age is ≥18 and ≤ 65 years at time of screening.
* Symptomatic PFOA grade 1-3 according to Iwano Classification
* Chondropathy Grade 3-4 according to ICRS classification of the patella, trochlea femoris or both
* Baseline score of \35 kg/m2.
* Patient has chronic rheumatoid arthritis, and/or infectious arthritis
* Any concomitant painful or disabling disease of the spine, hips, or lower limbs that would interfere with evaluation of the afflicted knee.
* Patient has a known immunological suppressive disorder or is taking immunosuppressives.
* Patient had any intra-articular injections into the affected knee within the last 3 months before baseline visit
* Instability of anterior, posterior collateral ligaments
* The patient has a HIV/AIDS infection. (regulatory requirement)
* The patient has an acute Treponema pallidum (syphilis) infection. (regulatory requirement)
* The patient has an active hepatitis B or C infection assessed according to local laboratory standards using an antibody test and if positive, confirmatory test for active infection. Patients with a cured hepatitis B or C infection are not excluded. (regulatory requirement)
* Patient is pregnant, breast feeding or anticipates becoming pregnant within 24 months after surgery.
* Patient is currently participating or has participated in any other clinical study within 3 months prior to the screening visit.
* Patient has known current or recent history of illicit drug or alcohol abuse or dependence defined as the continued use of alcohol or drugs despite the development of social, legal or health problems.
* Patient has any other condition, which, in the opinion of the investigator, would make the patient unsuitable for the study.
* Any known allergies, especially for porcine collagen, penicillin or streptomycin (manufacturing)
* patients with increased anesthesiological and surgical risks (e.g. known or predicted difficult airway, myocardial infarction \
Source: ClinicalTrials.gov (NCT06163573). StuddyBuddy aggregates publicly available trial information.