News Release

Artificial trachea recipient is fit and well five months after pioneering transplant

Peer-Reviewed Publication

The Lancet_DELETED

An article describing the world's first transplant of an artificial trachea seeded with stem cells is published Online First by the Lancet today. The 36-year-old Eritrean patient, Andemariam Teklesenbet Beyene, received the transplant in June at the Karolinska University Hospital, Stockholm, Sweden. The project was led by Professor Paolo Macchiarini at the Karolinska Institutet, Stockholm, Sweden.

Beyene had a tracheal tumour that extended to the lowest 5cm of the trachea along with both bronchi meaning that surgical removal of the tumour alone would not keep the patient alive: the removed section was essential for life and therefore had to be replaced. The tumour had grown to the size of a golf ball and had begun to restrict his breathing, meaning he was quickly running out of time. The operation lasted 12 hours and involved Prof Macchiarini and his team completely removed the affected area of the trachea and replacing it with tailor-made artificial structure.

The scaffold used in this case was prepared at the Karolinska Institutet with help from University College London, UK, who used 3D imaging to scan Beyene and then constructed a glass model of the affected section of his trachea to be replaced. The glass was then used to shape the artificial scaffold, before sending it on to the Karolinska Institutet to have the stem cells inserted. There, Beyene's own stem cells were used to populate the scaffold, turning it into a functioning airway.

Professor Macchiarini believes his technique offers advantages over other methods in transplantation and regenerative medicine. Firstly, by using the patient's own cells to populate the scaffold, there are no concerns over rejection and no immunosuppressive drugs are required. Secondly, since the implant is artificially constructed, it can be tailor-made to the patient's body size and shape. Not only does that mean no human donors are required (often involving long waiting periods), but it means that constructs can be made-to-fit for people (and tracheas) of all sizes, including children.

Beyene is a geology student currently living in Reykjavík, Iceland where he is studying for a PhD. His wife and two children are living in Eritrea. His youngest child is now seven months old, and the operation has meant he was able to meet his newborn son, who recently emigrated with Beyene's wife to Iceland. Beyene was referred for this pioneering transplant by Professor Tomas Gudbjartsson, Landspitali University Hospital and University of Iceland, Reykjavik, Iceland (a co-author of the study). Professor Gudbjartsson says*: The patient has been doing great for the last 4 months and has been able to live a normal life. After arriving in Iceland at the start of July, he was 1 month in hospital and another month in a rehabilitation center. Already at the rehabilitation center he could start to work on his Master of Science Thesis in Geophysics, a scientific project that he has been working on for the last years at the University of Iceland here in Reykjavik. For the last two months he has been able to focus on his studies and the plan is that he will defend his thesis at the end of this year."

Mr Beyene says*: "I am so grateful to everyone that has made this happen."

Professor Macchiarini has already carried out several other high-profile transplants in his career, with the most famous case being that of Claudia Castillo, the then 30-year old Colombian woman who was the first person to receive tissue-engineered tracheal transplant in 2008. However unlike Beyene's case, Castillo and others required a human donor was required.

Macchiarini has just transplanted a second patient**, a 30-year-old man from Maryland, USA, who also had a primary cancer of the airway and had a bioartificial scaffold inserted. This scaffold was made from nanofibres and thus, says Professor Macchiarini, represents a further advance from Beyene's transplant. His team is now hoping to treat a 13-month old South Korean infant with the same technique.

He concludes*: "We will continue to improve the regenerative medicine approaches for transplanting the windpipe and extend it to the lungs, heart, and oesophagus. And investigate whether cell therapy could be applied to irreversible diseases of the major airways and lungs."

In a linked Comment, Dr Harald C Ott and Dr Douglas J Mathisen, Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA, say the technique holds promise and the need for bioartificial grafts is substantial. They conclude: "To be adjudged successful, bioartificial organs must function over a long time—short-term clinical function is an important achievement, but is only one measure of success. Choice of ideal scaffold material, optimum cell source, well defined tissue culture conditions, and perioperative management pose several questions to be answered before the line to broader clinical application of any bioartificial graft can be crossed safely and confidently."

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Professor Paolo Macchiarini, Karolinska Institutet, Stockholm, Sweden. T) 46-760503213 E) paolo.macchiarini@ki.se

Alternative contact Katarina Sternudd, Media Relations, Karolinska Institutet. T) 46-524 83895 / 46-70-224 38 95 E) katarina.sternudd@ki.se

Dr Harald C Ott Massachusetts General Hospital and Harvard Medical School, Boston, MA, USA. T) 617-643-0494 E) hott@partners.org

*Notes to editors: quote direct from person indicated and not found in text of Article

**Extra info from Prof Macchiarini, not found within the Article


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