The transplant was performed November 17, 2011 at the Karolinska University Hospital in Huddinge, Stockholm, by Professor Paolo Macchiarini of Karolinska University Hospital and Karolinska Institutet, and colleagues. Professor Macchiarini led an international team that included Nanofiber Solutions Chief Technology Officer, Dr. Jed Johnson, and members of Harvard Bioscience.
Dr. Johnson designed and built the nanofiber tracheal scaffold to match the dimensions of the patients trachea, while Harvard Bioscience produced a specifically designed bioreactor used to seed the scaffold with Mr. Lyles own stem cells. Although this procedure represents the worlds second successful transplant of an artificial trachea, it is the first time electrospun nanofibers have been used to create the scaffold.
The nanofibers mimic the physical structure of the native trachea and allow for a more porous and better scaffold in which to successfully seed stem cells. The cells were grown on the nanofiber scaffold inside the bioreactor for two days before the transplant procedure. Because the cells used to regenerate the trachea were the patients own, doctors report there has been no rejection of the transplant, Mr. Lyles is not taking immunosuppressive drugs and there has been extensive vascularization of the implant which indicates it is well on its way to becoming a natural part of Mr. Lyles' own tissues.
"We wish to congratulate Dr. Macchiarini and his surgical team. It is an honor to have contributed to this historic life-saving procedure," said Ross Kayuha, Nanofiber Solutions CEO.
"This was truly a team effort," continued Kayuha. "From our perspective, the team synergy worked exceptionally well. From the early stages of implant design involving the surgeons and Dr. Johnson, to the development of the Harvard Bioscience bioreactor that seeded the implant with the patients stem cells, through the surgery itself, performed by a world-class surgical team headed by Dr. Macchiarini, there was a real sense of urgency to produce a result that would benefit Mr. Lyles in the best possible way. We wish Mr. Lyles a speedy recovery and the enjoyment of a long, happy life with his family."
Nanofiber Solutions was founded based on a technology licensed through The Ohio State University. The company is a global developer, manufacturer and marketer of products to advance life science research, tissue engineering and regenerative medicine. Nanofiber Solutions is a 2009 recipient of a TechGenesis grant from TechColumbus and is located in the TechColumbus center in Columbus, OH.
This historic accomplishment heralds a major breakthrough in medicine, namely the ability to produce synthetic nanofiber organs. It is also at the forefront of two major trends in medicine today. The first is tissue engineering, or the use of artificial scaffolds in the body, and the second is regenerative medicine, including the use of a patients own stem cells to increase the likelihood of a scaffolds acceptance and success.