| NEWSRoom | Source: Harvard Bioscience | |
Era of Synthetic Voicebox Gets Nearer Following Two Surgeries in Russia |
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No human has ever been given a complete synthetic larynx, the organ that gives us our voice. But that day may now be a little closer, following a pair of surgeries in Russia in which two patients received a chunk of larynx along with part of a trachea. On June 19 and June 21, patients Julia T. (age 34) and Aleksander Z. (age 28) successfully underwent the world’s first successful laryngotracheal implants in Russia. Each patient was implanted with a synthetic part about five centimeters long, consisting of a section of the trachea, at the top of which was a version of the cricoid arch and plate—a hollow, collar-like segment that forms the base of the larynx. The surgeries involved nanocomposite scaffolds seeded with autologous mononuclear cells taken from the patients’ bone marrow. The implants were created from a synthetic scaffolds seeded with the patients’ own stem cells. The laryngotracheal transplants were the most complex synthetic part yet transplanted, and is the first step to creation of a complete larynx, including the parts that produce sound. And, because each patient’s own stem cells were used, their bodies have accepted the transplants without the use of immunosuppressive drugs. The transplant procedures, which required more than a half-year of preparation, were the first two in a clinical trial initiated at the Krasnodar Regional Hospital in Krasnodar, Russia. 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. Ms. T., a former ballet dancer and mother of one child from St. Petersburg, was in a car crash and subsequently in a coma for an extended period, during which she sustained cicatricial stenosis of the trachea. This involved a huge tracheal defect 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. Mr. Z., a 28-year-old agricultural worker from Rostov-on-Don in the south of Russia, was also in a car accident. As a result, he sustained multiple fractures and was in coma for two weeks, leading to tracheal stenosis. He could not speak and could hardly breathe. Via the Internet, he learned about the technology and the transplant program at Krasnodar Regional Hospital. In February 2012, he applied to the hospital to be considered as a patient. Following his recovery, he hopes to further his higher education. The principal transplant surgeon and main coordinator for both procedures was Dr. Paolo Macchiarini, Professor of Regenerative Surgery at Karolinska Institute in Stockholm. He 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 Sergey Sitnick, anesthesiologist and head of the intensive care unit. Ms. T. and Mr. Z. 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. The surgeries were approved by the Russian health ministry and performed at the Krasnodar Regional Hospital, the leading transplant hospital in Russia. Ms. T. and Mr. Z. were chosen for the surgery following a conference involving Dr. Macchiarini and five other surgeons, each of whom presented potential candidates for the procedure. The key technology behind the surgeries was a shoebox-sized apparatus known as a bioreactor, created by Holliston, Massachusetts-based Harvard Bioscience, in which the new custom-designed organs were grown. Bioreactors were especially designed for each patient. Each bioreactor was loaded with a “scaffold” in the shape of each patient’s original organ; over the course of about two days at Krasnodar Regional Hospital, the scaffold was rotated inside the bioreactor while its surface was soaked with stem cells taken from a bone marrow biopsy from each patient. The scaffolds were created by Columbus, Ohio-based Nanofiber Solutions. The scaffold seeding process was overseen by a team comprising Philipp Jungebluth of the Karolinska Institute; hematologists Irinia Gilevich and Pashkova of Krasnodar Regional Hospital; and Thomas Grosse of Hugo Sachs Elektronik. The scaffolds for Ms. T. and Mr. Z. were sterilized in Germany at Hugo Sachs Electronik, a wholly owned subsidiary of Harvard Bioscience, prior to being brought to Russia, while the bioreactors were sterilized by technicians on site in Krasnodar. The fact that the scaffold and the bioreactor can be sterilized by individuals other than the surgeons themselves, is a key improvement that will make it much easier to scale up and offer the surgery to hundreds or even thousands of patients. News of these surgeries in Russia comes at an interesting juncture: Andemariam Beyene, a 37-year-old man from Eritrea, celebrated the one-year anniversary of a related procedure, a tracheobronchial transplant, on June 9. Dr. Macchiarini also led Beyene’s procedure. “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,” said David Green, President of Harvard Bioscience. “We see these surgeries as a key step toward the exciting goal of one day replacing a complete larynx.” For more information, log on to www.harvardbioscience.com |
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