Personalized Tissue Engineered Arteries (P-TEA) as a Novel Cure for Cardiovascular Disease

Purpose and goal

We have successfully achieved the aims and goals of the project by developing a P-TEA manufacturing process, setting up a well-functioning animal model for in vivo P-TEA testing and demonstrating that the production process provides sterile blood vessels and that they are functional and safe to use. We will now go ahead and apply for Step 2 in the same call to take the next step towards testing these grafts clinically.

Expected results and effects

We have successfully developed a working process to wash away cells from donated arteries and recondition these cell free scaffolds with the recipient´s own blood, in a sterile way. These P-TEAs have been evaluated in an animal model with good results regarding safety and function. We have not seen any signs of infection or rejection, and after four months, all vessels had good blood flow without any signs of clot formation. A new patent application has been submitted. The next step will be to apply for an extended animal study in the same model to obtain more data for a future clinical study.

Planned approach and implementation

A protocol was developed to wash away all donor cells from arteries from slaughter waste, to produce cell free artery scaffolds. A sterilization method for the scaffold and a protocol for reconditioning with recipient blood to produce sterile P-TEA were developed. A sheep model for testing P-TEA transplants was set up and an initial pilot study and subsequent safety and function studies performed. A second pilot study has been performed to evaluate arteries from another species, and modification of the original medication. The results have been very successful and have led to new IP.