At a glance
ClinicalIndex Comparison Record- ✓Age 18-65 years
- ✓Symptomatic PFOA grade 1-3 by Iwano Classification
- ✓Chondropathy Grade 3-4 by ICRS classification of patella, trochlea femoris or both
- ✓KOOS Pain score <60
- ✕Unable to understand patient information
- ✕Unable to undergo MRI
- ✕Prior knee surgery within 12 months (except diagnostic arthroscopy with debridement/lavage)
- ✕Tibiofemoral degenerative joint disease Kellgren-Lawrence grade >2
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of Patellofemoral Osteoarthritis With Nasal Chondrocyte-based Engineered Cartilage Implantation in a Randomized, Controlled, Multi-center Phase II Clinical Trial
In Brief
A Phase 2 clinical trial evaluating N-TEC and Platelet rich plasma for Patellofemoral Osteoarthritis. Currently recruiting, targeting 75 participants across 9 sites in 3 countries.
Detailed 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.
Study Details
Timeline
Interventions
Implantation of an autologous tissue engineered cartilage graft in the patellofemoral joint for treatment of osteoarthritis.
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.