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-therapies (N-CAM)
The clinical trial “Nose to Knee II” is a phase II multicenter clinical trial based on the phase I study described above, which focuses on efficacy and the comparison of grafts in different maturation stages and therefore requires higher patient numbers to be statistically significant. Patients, between 18 and 65 years old, suffering from articular cartilage lesions not related to an inflammatory state, are treated in four different countries: Croatia, Germany, Italy and Switzerland and will be followed for up to 2 years.
We are currently recruiting.
Tissue engineered nasal cartilage for the regeneration of articular cartilage in the knee after traumatic injury
Although articular cartilage lesions are more common in older people due to degeneration, they also occur regularly in younger people e.g. due to accidents. Particularly in the case of larger defects, spontaneous healing is almost never observed and, if no adequate treatment is carried out, development of an arthrosis can finally occur, which may ultimately lead to full joint replacement. We proposed here the use of the same type of engineered cartilage grafts as described in the study above.
The aim of this phase I study is to treat patients with cartilage defects of 2-8cm2 in the knee (but not arthrosis) in order to demonstrate the safety and feasibility of this method of treatment and to collect initial results for efficacy.
ROBUST – Regeneration of osteoporotic bone using stem-cell transplantation
Secondary dislocation and screw perforation after surgical treatment of proximal humeral fractures is a major complication after auto- or allo-graft-based augmentation and leads to pain, functional restrictions and ultimately to re-operation. The aim of this study was to test as a first-in-human trial the feasibility and safety of an augmentation by SVF cells-seeded composite osteogenic grafts in combination with an angle-stable fixation (Philos plate®) for the therapy of osteoporotic proximal humeral fractures.
Tissue Engineered Nasal Cartilage for Reconstruction of the Alar Lobule
Autologous native cartilage from the nasal septum, ear, or rib is currently the standard material for surgical reconstruction of the nasal alar lobule after two-layer excision of non-melanoma skin cancer. We assessed in a phase I clinical study whether engineered autologous cartilage grafts allow safe and functional alar lobule restoration. These grafts are based on the use of chondrocytes from the nasal septum of the patient and the implantation of a tissue rather than cells.