Int J Surg. 2024 Aug 5. doi: 10.1097/JS9.0000000000001843. Online ahead of print.
ABSTRACT
OBJECTIVE: This phase I clinical trial assessed the use of autologous nasal chondrocyte tissue-engineered cartilage (N-TEC) for functional repair of nasal septal perforations (NSP).
BACKGROUND: The most widely used technique to treat NSP, namely interposition grafting with a polydioxanone (PDS) plate combined with a deep temporal fascia (DTF) graft, is still suboptimal towards patient satisfaction and revision rates.
METHODS: Patients (n=5, all female, age range: 23-54 years) had a 0.5-2.0 cm diameter NSP. N-TEC was manufactured by expansion and 3D culture of autologous nasal septum chondrocytes into Chondro-GideĀ® collagen membranes. N-TEC was then shaped intraoperatively and enveloped in the harvested DTF before suturing it into the NSP. Safety (primary outcome) was assessed by the number of serious adverse reactions (SAR) until 12 months. Secondary outcomes included feasibility, assessed by surgical graft manipulation, and efficacy, assessed using subjective scoring (Nasal Obstruction Symptom Evaluation, NOSE, and Visual Analogue Scale, VAS, scores) and objective breathing function tests. Structural closure of NSP after 12 months was defined using endoscopy and computed tomography (CT) scans.
RESULTS: NSP treatment by N-TEC implantation was safe and feasible, as no SAR and no challenge in graft manipulation was recorded for any of the patients. One year postoperative, subjective scoring improved in all patients, unless already optimal (average improvement of 23 and 28.6 points out of 100 respectively for NOSE and VAS scores). Objective respiratory function overall confirmed – with the exception of one case – the observations above (average improvement of 172 ml/s). NSP were closed and the mucosae completely healed in three patients.
CONCLUSION: Autologous N-TEC is a valid treatment for NSP and warrants further clinical tests.
PMID:39197067 | DOI:10.1097/JS9.0000000000001843
