Treatment of Patellofemoral Osteoarthritis With Engineered Cartilage.

ConditionPatellofemoral Osteoarthritis

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-65

SponsorUniversity Hospital, Basel, Switzerland

About this trial

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

Qualifiers

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 <60 on the KOOS Pain subjective knee evaluation.

Disqualifiers

Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol or in a dependency or employment with the sponsor.

Patient is unable to understand the patient information

Patient is unable to undergo magnetic resonance imaging (MRI)

Prior surgical treatment of the target knee within 12 months (Note: prior diagnostic arthroscopy with debridement and lavage are acceptable within 12 months).