Dr Alberto Sensini, Alma Mater Studiorum - Università di Bologna; Dr Luca Cristofolini, Alma Mater Studiorum - Università di Bologna; Dr Chiara Gualandi, Alma Mater Studiorum - Università di Bologna; Dr Maria Letizia Focarete, Alma Mater Studiorum - Università di Bologna; Dr Juri Belcari, Alma Mater Studiorum - Università di Bologna; Dr Andrea Zucchelli, Alma Mater Studiorum - Università di Bologna
Tendon and ligament regeneration is complex since the scaffold has to bear high loads and stress concentrations, while providing some compliance. No satisfactory clinical solutions are currently available for lesion such as those of the rotator cuff or achille’s tendon. A key role is played by a physiological orientation of the fibers, and good cell adhesion on the scaffold. The present invention is referred to a scaffold able to reconstruct/replace the tendon/ligament.
In the field of tissue engineering, the scaffold has a key role in order to confer an ideal environment for cells adhesion, migration and proliferation. The multiscale morphology of the scaffold is crucial for a fast and suitable regeneration of the tissues. The inventors conceived an electrospun nanofibrous multiscale scaffold that permits to regenerate and/or replace the tendon and/or ligament tissue. In particular the scaffold is able to reproduce the hierarchical structure and the biomechanical properties of tendons and ligaments. The inventors also designed a method for adding a nanofibrous sheath on the scaffold (similar to the epitenon/endotenon and/or epiligament/endoligament) able to keep the individual bundles together, thus conferring protection, mechanical properties, while promoting cell filtration.
Tendon and ligament injuries and associated diseases such as tendinopathy, are a common cause of occupational and sporting disability. In the U.S. alone, tendon, ligament, and joint capsular injuries account for 45% of the 32 million musculoskeletal injuries each year with rates rising due to increasing sports participation and an aging population. The already significant financial burden to the public health care system is expected to increase as the population ages. More effective treatments will become indispensable. If the multiscale scaffold is made of resorbable materials it will allow regenerating and repairing the tendon and ligament tissue as an implantable device. If the multiscale scaffold is manufactured with inert materials, it will be used as a prosthetic implantable device for tendon and ligament replacement. The device could also be used as a tendon/ligament mock-up for training and for in-vitro testing new surgical techniques or tendon/ligament devices. It can also be used in the soft robotics or sensing.
Several prototypes of multiscale scaffolds, made of either resorbable or inert materials (poly(lactic acid), poly(lactic acid)-collagen blends and nylon 6.6), were tested for their mechanical properties and cells proliferation. The multiscale morphology was assessed with scanning electron microscopy and high-resolution x-ray tomography investigations. Overall: TRL4.
Priority application has been filed on June, 2017.
 A. Sensini, C. Gualandi, L. Cristofolini, G. Tozzi, M. Dicarlo, G. Teti, M. Mattioli-Belmonte, M. L. Focarete, Biofabrication of bundle of poly(lactic acid)-collagen blends mimicking the fascicles of the human Achille tendon, Biofabrication, 9, pp. 1 - 16, 2017.
 A. Sensini, A. P. Kao, G. Tozzi, M. L. Focarete, J. Belcari, A. Zucchelli, L. Cristofolini, High-resolution x-ray tomographic morphological characterization of electrospun nanofibrous bundles for tendon and ligament regeneration and replacement, in press on Journal of Microscopy, 2018.
 A. Sensini, C. Gualandi, A. Zucchelli, L. Boyle, A. P. Kao, G. G. Reilly, G. Tozzi, L. Cristofolini, M. L. Focarete, Tendon Fascicle-Inspired Nanofibrous Scaffold of Polylactic acid/Collagen with Enhanced 3D-Structure and Biomechanical Properties, under revision Scientific Reports