A tracheal cancer patient traveled to Sweden for a surgery so new that only one surgeon in the world can perform it. In November, the cancerous trachea was replaced with a fully synthetic one- seeded with the patient’s own stem cells.
Christopher Lyles, a 30-year-old engineer from Baltimore was diagnosed with cancer of the trachea; a cancer so rare that very little research had been done on this condition. Given the size of the tumor Lyles was told surgery was not an option and that the less successful and only option would be chemotherapy and radiation.
The need to survive empowered Lyles to search for an answer, and he found one. Dr. Paolo Macchiarini a surgeon in Sweden was the first to ever do a replacement trachea transplant using a regenerative approach. He has successfully performed two trachea transplants; once using a donor scaffold and for the other he used a synthetic scaffold, this same type of scaffold was used in Lyles surgery, “but this one worked much better than the first one,” said David Green, President of Harvard Bioscience and developer of the “InBreath” bioreactor that seeded the implant with the patients stem cells.
This trachea was created in a joint effort between Nanofiber Solutions LLC and Harvard Bioscience. The scaffold must be custom made for the patient, the nanofibers used to create the scaffold mimic the structure of the native trachea and create a more porous scaffold in which to seed the stem cells.[i] To create the fully synthetic scaffold, bone marrow is used for the cells and they are taken out and seeded to the scaffold and then are incubated in the bioreactor which allows the stem cells to become seeded into the scaffold for a few days then the construct of the scaffold plus the stem cells is implanted in the patient.
Lyles traveled to Karolinska University Hospital in Huddinge, Stockholm to have his surgery, “Dr. Macchiarini invented the technique and at the moment he is the only one with the knowledge, and can do all the steps,” said Green. He put together a team of experts to make this happen.
“You have to have the best expertise in the world in each one of these areas, you need the best bioreactor on the planet, you have to have the best scaffold on the planet and you need the best surgical team on the planet, that’s how cutting edge this technology is today,” said Green.
Two patients have been publicly disclosed that Macchiarini plans to treat in the U.S., pending FDA approval. One is a 13-month-old baby who was born without a trachea and the other is a woman in her 30’s who has a degenerative condition with her collagens which causes her trachea ( made of collagen) to collapse every time she breaths out. The FDA must approve these on a case by case basis.
Green is expecting that in the next year the development of the bioreactor and the scaffold will be well enough developed that it will become like a product and a top surgeon at a major transplant center will be able to perform this in the U.S. He also has hope in the future to extend this technology to the esophagus which is more common type of cancer.
Lyles and his family started a donation platform online to raise money to cover his surgery expenses; this experimental procedure is not covered by health insurance. He has captured the interest and concern from many people and Facebook is the medium he uses to keep people updated about his status in the hospital. Lyles last posted on December 17, 2011 he said “I am doing a lot better. I had a few setbacks that are going to have me here in Sweden a lot longer than expected. I will not be back until after the holidays but I am up and about walking again so that’s a great sign.”