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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \<60 on the KOOS Pain subjective knee evaluation.
* Free range of motion of the affected knee joint or ≤ 5° of extension loss and minimum 125° flexion.
* Patient is willing and able to give written informed consent to participate in the study and to comply with all study requirements, including attending all follow-up visits and assessments and to complete postoperative rehabilitation regimen.
* Minimum values for women: Haemoglobin 120g/l, Platelets 150G/l, INR\<1.3
* Minimum values for men: Haemoglobin 140g/l, Platelets 150G/l, INR\<1.3
* Non-surgical standard of care options except for PRP have been exhausted.
Exclusion Criteria:
* 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).
* Radiologically apparent degenerative joint disease of the tibiofemoral jo…
What they're measuring
1
Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain