Regenerative medicine pioneer continues changing lives with first successful laryngotracheal implants

Dr. Paolo Macchiarini is no stranger to world firsts, and less than a year after performing a synthetic windpipe transplant, the Karolinska Institute Professor has coordinated no less than two successful transplants of synthetic sections of larynx. Amazingly, both patients were able to breathe and talk normally straight after surgery, the basic functions we take for granted that they either struggled with or were simply unable to do before. The implants consisted of personally designed synthetic scaffolds coated with the candidates' own stem cells, so there's neither the chance of rejection nor the burden of life-long immunosuppressant therapy. Despite the amazing feat, Dr. Macchiarini ain't done yet, claiming this is the first of many steps towards building a synthetic, complete larynx -- voice box and all. Jump past the break for the official PR issued by Harvard Bioscience, the company responsible for growing what's in that tub.

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Harvard Bioscience's "InBreath" Bioreactors Used in World's First Successful Regenerated Laryngotracheal Transplants


First Two Transplants Performed in Government-Approved Clinical Trial in Russia


HOLLISTON, Mass., June 26, 2012 (GLOBE NEWSWIRE) -- Harvard Bioscience, Inc. (HBIO), a global developer, manufacturer, and marketer of a broad range of tools to advance life science research and regenerative medicine, announces that its "InBreath" bioreactors were used for the world's first and second successful laryngotracheal implants, using synthetic
laryngotracheal scaffolds seeded with cells taken from the patients' bone marrow. The surgeries took place at Krasnodar Regional Hospital in Krasnodar, Russia on June 19th and June 21st. The recipients of the implants, Julia T. and Aleksander Z., are recovering well. The implants in the procedures were grown in bioreactors developed by the regenerative medicine device business of Harvard Bioscience.


The transplants, which required more than a half-year of preparation, were performed on
the first two patients enrolled in an ongoing clinical trial at Krasnodar Regional Hospital. The Russian Ministry of Health has approved a clinical protocol for an unlimited number of
patients in this trial, all of which will involve trachea procedures.


Each bioreactor was specifically adapted by Harvard Bioscience to the clinical requirements
for each patient. Each bioreactor was loaded with a synthetic scaffold in the shape of the
patient's original organ. The scaffolds were then seeded with the patient's own stem cells.
Over the course of about two days, the bioreactor promoted proper cell seeding and
development. Because the patients' own stem cells were used, their bodies have accepted
the transplants without the use of immunosuppressive drugs.


A photo accompanying this release is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=13437


The procedures are the result of a global collaboration involving organizations in the US,
Sweden, Russia, Germany, and Italy:


-- The bioreactors were developed, manufactured and prepared by teams at Hugo Sachs Elektronik, a German subsidiary of Harvard Bioscience and at Harvard Bioscience, based in Massachusetts, U.S.A.


-- The scaffolds were created by US-based Nanofiber Solutions.


-- The principal transplant surgeon and main coordinator for both procedures was Dr. Paolo Macchiarini, Professor of Regenerative Surgery at Karolinska Institute in Stockholm.


-- Dr. Macchiarini was assisted by a team of surgeons including Dr. Vladimir Porhanov, Chief Doctor of Krasnodar Regional Hospital and head of the Oncological and Thoracic Department of Kuban State Medical University; thoracic surgeons Dr. Igor Polyakov and Dr. Nikolay Naryzhnyi, of Krasnodar Regional Hospital; Dr. Anatoly Zavrazhnov, deputy chief of Krasnodar Regional Hospital; and Dr. Sergey Sitnick, anesthesiologist and head of Krasnodar Regional Hospital's intensive care unit.


-- Dr. Alessandra Bianco at University of Rome, Tor Vergata, performed mechanical testing during scaffold development.


-- The scaffold seeding process, which occurred at Krasnodar Regional Hospital, was overseen by a team comprising Dr. Philipp Jungebluth of Karolinska Institute; hematologists Dr. Irina Gilevich and Dr. Irina Pashkova of Krasnodar Regional Hospital; and Thomas Grosse of Hugo Sachs Elektronik.


-- The patients were treated under a $4.8 million, 2.5-year Russian government Mega-Grant program intended to fund collaborations between Russian scientists and doctors and international leaders in their fields. The principal aim of the grant is to evaluate the molecular mechanisms and underlying pathways of tissue engineering and cell therapy for regenerating airways and lung tissue, and to carry out translational studies for the prevention and effective treatment of a wide range of diseases.


A photo accompanying this release is available at http://www.globenewswire.com/newsroom/prs/?pkgid=13438


Dr. Macchiarini commented, "I am very satisfied with the results of these transplantations, they are even better than those in my previous practice. Both patients are doing very, very well. Initial tests have already demonstrated the beginning of the epithelialization process on the transplanted tracheas."


Dr. Porhanov commented, "These surgeries are our first steps. We have identified at least four more candidates for these transplants and we hope to help them in the near future. We plan to establish an International Center of Excellence in regenerative medicine here in Krasnodar."


Ms. T., a 34-year-old mother of one child from St. Petersburg, was in an automobile accident and subsequently lapsed into a coma for an extended period, during which she sustained cicatricial stenosis of the trachea. This resulted in a significant tracheal occlusion and chronic infection of the trachea and lungs, along with a wide fissure in the neck. In order to speak, Ms. T. had to cover her neck fissure with her hand. Immediately after the surgery she was able to speak and breathe normally.


Mr. Z., a 28-year-old agricultural worker from Rostov-on-Don in the south of Russia, was in a car accident in June 2011. As a result, he sustained multiple fractures and was in a coma for two weeks, leading to tracheal stenosis. He could not speak and could hardly breathe. Mr. Z. was also able to speak and breathe normally following his surgery.


David Green, President of Harvard Bioscience, commented: "We are very pleased to have participated in additional medical procedures involving a regenerated trachea and to begin the first government-approved clinical trial for regenerated tracheal transplants. We congratulate Professor Macchiarini for achieving another world's first in regenerative medicine--the world's first laryngotracheal transplants. We are also very pleased to collaborate with Professor Porhanov and the Krasnodar Regional Hospital in Russia. Professor Porhanov is a very well-known thoracic surgeon who has led his hospital in performing over 80 heart transplants in the last two years. As a specialized cardio-thoracic transplant hospital, they are very well qualified to begin this clinical trial."