We have treated over 100 patients so far for knee focal cartilage defect. The vast majority of patients report significant improvement in symptoms based on self-assessed clinical scores. Data from the latest international, multicenter phase II study in Europe are currently in peer review and will be published in 2023 after review by independent experts. For information on previous studies by the group, see under Science.
The patient comes a first time to the hospital for harvesting a nasal cartilage biopsy under local anesthesia, a procedure that takes about 1-2 hours. Afterwards, a N-TEC product is produced in a sterile clean room starting from his own cells and manufacturing takes about a month. When the engineered cartilage is ready, the patient comes back for implantation under general anesthesia.
The operation is followed by a hospitalization of three to five days and a physiotherapy program. In the first week after operation, the leg is immobilized, afterwards the patient has to use crutches for six weeks, while the leg is mobilized increasing the range of motion each week. Subsequently, the patient starts exercises to regain the strength of the leg. After three months light sport (swimming, biking) is possible, after one year the patient can return to normal sport activities.
Outcomes vary between individual patients. Preliminary data from the latest study show that while most patients (88 percent) experience a significant benefit and respond to the therapy returning back to normal life and sports, some do not feel any improvement (10 percent), and others experience further joint deterioration (two percent).
N-TEC has not been approved by the FDA and the procedure is currently not in clinical trials in another country other than Switzerland. Today, the main hospital performing N-TEC procedures is the University Hospital Basel, Switzerland, within a framework approved by regulatory authorities.
N-TEC is manufactured in specialized facilities by expertly trained personnel. Including manufacturing, clinical, and personnel costs, the treatment amounts to about 30’000 CHF – $35,000 U.S. However, with routine production and automation of the process, these costs can be significantly reduced. Since N-TEC is not yet an “approved” procedure, insurances will currently not cover the costs of this experimental procedure. The research group at the University of Basel and University Hospital Basel covers the costs for the procedure in the clinical trials for the patient, and so, the number of treatments is limited by current available funding.
The researchers are currently recruiting patients for the treatment of kneecap OA in the knee, cartilage lesions in the ankle and shoulder joint trials. Patients need to be between 18 and 65 years old and should not have other co-morbidities in the joints. Specific inclusion and exclusion criteria will be evaluated by the treating physician based on MRI and physical examinations.
All procedures and follow-up appointments take place at the University Hospital in Basel, Switzerland. Therefore, any participant in the trials will need to travel to Basel for many appointments throughout the first year of the trial. Regular appointments are also planned during the follow up period for at least 2 years. All travel costs need to be paid by the patients. Remote participation is not possible.
Currently we are not planning N-TEC treatment for the treatment of cartilage defects in hip joints. The reason is that the implantation of N-TEC would require an open surgery on the hip with associated complications. Today, the patient outcomes for hip prosthesis have a very high success rate (>98%).
We do not have any partners in the U.S. yet doing similar work. Therefore, N-TEC is not yet available in the US. Further successful experimentation in Switzerland, however, is expected to make the procedure also to be adopted in the US on the long term.
The harvesting of the cartilage graft is performed by experienced plastic surgeons under local anesthesia and does not damage the nose. The cartilage graft is very small (6mm diameter) and taken from one side of the nasal septum within the nose. Therefore, no scarring can be seen from the outside and the septum is not perforated. Due to the small amount of tissue taken, neither the stability of the nose nor the functionality of the breathing are compromised by this intervention. In over 100 patients so far, none have reported any serious adverse reactions to the procedure.
Research and especially clinical trials are very expensive and often not fully funded by conventional grants. Therefore, for our translational research we are relying on additional funding by private sponsors and foundations to carry out the necessary research and clinical studies to finally apply for an official approval authorization. Once authorized, other clinics will be able to offer the treatment.