This past summer's successful transplantation of a tissue-engineered trachea would not have been possible without a custom-designed bioreactor from Harvard Bioscience, Inc. The operation was performed on 9 June 2011 in Sweden by Professor Paolo Macchiarini of Karolinska University Hospital and Karolinska Institutet, with colleagues. He led an international team including Professor Alexander Seifalian from University College in London, UK, who designed and built the nanocomposite tracheal scaffold.

Stem cells were grown on a scaffold inside an “InBreathe” bioreactor for two days before transplantation. Because those cells were the patient's own, no immunosuppressive drugs were needed, and there has been no rejection of the transplant. The patient, a 36-year old man who had been suffering from late-stage tracheal cancer (inoperable before this surgery), was discharged from the hospital within a month.

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Harvard Bioscience president David Green called this a “landmark in the history of regenerative medicine. This new type of surgery is likely to greatly expand the patient population treatable with organs grown in Harvard Bioscience's bioreactor. Previously, our bioreactor had been used to seed a patient's stem cells onto a donor trachea, so treatment was limited by the supply of donor organs. Now patients will not need to wait for a suitable donor trachea to become available.”

Green's company creates devices for regenerative medicine, building on existing technologies and developing devices, and estimates that this nascent market could grow to hundreds of millions of dollars annually. However, these products are currently sold for research use only and cannot be used for human patients unless proper local investigational device regulations are followed.