Our project titled “Personalized ATMP for the regeneration of arteries”, funded by CAMP (Centre for Advanced Medicinal Products) and in collaboration with RISE (Research Institute of Sweden), Sahlgrenska University Hospital, Gothenburg University and YSDS (Your Special Delivery Service), has been extended.
The completed project will make our P-TEA (Personalized Tissue Engineered Artery) product ready for going into final development and clinical proof-of-concept.
Vascular grafting is an important treatment of cardiovascular diseases to bypass or replace diseased blood vessels. Due to the many problems with the grafts available today, there is a need for fully biological personalized arterial grafts targeting several indications with extensive medical needs. P-TEA grafts will provide vascular surgeons with a ground-breaking therapeutic tool to replace defective tissues and to restore physiological function, without the need for immunosuppressive drugs.
The grafts in this project are produced with a novel and unique technology that can transform an allogeneic (foreign) blood vessel into an individualized graft and are supposed to not evoke an immunoreaction in the recipient. The initial project has been focusing on intermediate length arterial grafts, to be used for clinical indications such as bypass after myocardial infarction, and arteriovenous fistula used for dialysis patients. Based on the very successful results from the original project with regards to graft function and patency the extra funding will be used to complete the in vivo safety and functionality evaluation of long P-TEA grafts.
These long grafts would open additional clinical opportunities with a large need of improved vascular grafts, for example peripheral artery disease (PAD).
The extended support will be used for additional long-term large animal studies and the main results of the project will comprise
- a complete large-animal safety data-package
- a scaled-up protocol
- adaption of the production process of P-TEA to Good Manufacturing Practice (GMP) as preparation for a clinical study
- initiation of a dossier of regulatory documentation to be used for the future clinical trial submission to the European competent authorities.
VERIGRAFT is dedicated to reshaping the future healthcare by developing revolutionizing methods for producing tissue grafts that do not require immunosuppressive drugs.