Recent Progress in Translation from Bench to a Pilot Clinical Study on Total Pulp Regeneration
Based on a preclinical bench study in dogs, a pilot clinical study was completed. Dental pulp stem cell (DPSC) subsets were isolated by mobilization by granulocyte colony-stimulating factor and expanded in good manufacturing practice conditions. The safety and efficacy of their autologous transplantation for total pulp regeneration was assessed in 5 patients with irreversible pulpitis. The quality control of the DPSC subsets was ensured by the absence of contamination and karyotype aberrations, and positive expression of stem cell markers. The clinical safety assessment was based on laboratory and radiographic evaluations, demonstrating no evidence of toxicity and adverse events. The efficacy was determined by the recovery of a sound positive response to the electric pulp test within 4 weeks and by the robust signal intensity of magnetic resonance imaging in the root canal at 24 weeks. The functional recovery of pulp tissue was determined by lateral mineralized tissue formation detected by cone beam computed tomography. This review presents a summary of the accumulating data in translation from bench to a pilot clinical study, demonstrating potential clinical utility of DPSC subsets for total pulp regeneration in endodontics.