Randomized, Multi-center Phase II Clinical Trial for the Regeneration of Cartilage Lesions in the Knee Using Nasal Chondrocyte-based Tissue (N-TEC) or Nasal Chondrocyte-based Cell (N-CAM)-Therapies (NosetoKnee2)

NCT02673905 NA COMPLETED

The purpose of this study is to investigate the efficacy of an engineered cartilage transplant (N-TEC) in comparison to a cell-activated matrix (N-CAM) for the treatment of articular cartilage lesions in the knee. The main innovations in this trial are the use of nasal chondrocytes and the implantation of a tissue in contrast to cells seeded on a matrix. The goals of the trial are to: (i) evaluate whether implantation of a more mature graft (tissue therapy) is beneficial for the quality and durability of the repair tissue and the clinical outcome, (ii)determine the potential of the mature graft to integrate with the adjacent cartilage and form hyaline repair tissue and (iii) assess the efficacy of each treatment in correlation to the characteristics of the defect (e.g. "acute" versus "chronic" setting).

Details

Lead sponsor	University Hospital, Basel, Switzerland
Phase	NA
Status	COMPLETED
Enrolment	108
Start date	2016-11
Completion	2022-11-15

Conditions

• Tear; Knee, Cartilage, Articular

Interventions

• Tissue Engineered Product

Primary outcomes

• comparison of the efficacy of the two investigational medicinal products (IMPs) — 24 months
  Assessment whether a tissue therapy will improve the clinical efficacy for the patient, leading to an increase of at least 10 points in the main primary outcome (self-assessed score KOOS) after 24 months as compared to the cell therapy group

Countries

Croatia, Germany, Italy, Switzerland