Optic IconOptic Logo
|
SearchCollectionsBenchmarks
Clinical trial

Treatment of Patellofemoral Osteoarthritis With Nasal Chondrocyte-based Engineered Cartilage Implantation in a Randomized, Controlled, Multi-center Phase II Clinical Trial

ID
Name
2023-508640-21-00
Description
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.
Trial arms
Trial start
2024-04-01
Estimated PCD
2028-09-01
Trial end
2029-09-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
N-TEC
Implantation of an autologous tissue engineered cartilage graft in the patellofemoral joint for treatment of osteoarthritis.
Arms:
N-TEC
Other names:
Engineered cartilage graft
Platelet rich plasma
Injection of an autologous Conditioned Plasma ACP® on the basis of one injection per week for three consecutive weeks. Conditioned Plasma ACP®, Arthrex, one injection per week for three consecutive weeks.
Arms:
Platelet Rich Plasma
Other names:
PRP
Size
75
Primary endpoint
Knee Injury and Osteoarthritis Outcome Score (KOOS) for pain
24 months
Eligibility criteria
Inclusion Criteria: * 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. Exclusion Criteria: Intra operative exclusion criteria: * Advanced OA of tibiofemoral compartment of the knee * 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 joint as determined by X-ray (Kellgren and Lawrence grade \>1) or MRI or pain in the tibiofemoral joint (clinical examination) * Excessive varus or valgus deformity (\>5°) * Symptomatic meniscus lesion, as indicated by clinical examination (joint line tenderness and McMurray test positive) and MRI. * Patient has a body mass index (BMI) \>35 kg/m2. * Patient has chronic rheumatoid arthritis, and/or infectious arthritis * Patellar dislocation in the last 2 years
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Experimental group: biological: Autologous nasal chondrocytes and ECM proteins Control group: Platelet rich plasma injections', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 75, 'type': 'ESTIMATED'}}
Updated at
2023-12-11

1 organization

2 products

1 indication

Organization
University Hospital Basel
Product
N-TEC
Indication
Patellofemoral Osteoarthritis
Product
Platelet rich plasma