Xconomy: Ex-Harvard Bio Prez Leads Spin-Off’s Plan to Make Engineered Organs
Summary
Ex-Harvard Bio Prez Leads Spin-Off’s Plan to Make Engineered Organs (Page 2 of 3) stripped the donor trachea of all of its cells first, leaving just a collagen tube.They then used the tube as a scaffold upon which to build the new organ, placing it in the bioreactor and seeding it with cells derived from the patient’s own bone marrow and airway.And in early conversations with the FDA it became clear that in order to win regulatory approval the company would also have to control the process of seeding patient’s cells into the scaffolds to create the engineered organs, Green says.If the company simply supplied the scaffolds and bioreactors to doctors and left the seeding process up to them the risk of contamination would be too high and quality control would be lacking, he says.Harvard Bio would take care of the seeding and incubation steps and, within a few days, ship a completed organ back to the surgeon, who would perform the implantation.