By Juan Duran
In the article, Manufacturing Organs: Harvard Bioscience spin-off is stepping up its production of synthetic tracheas to supply clinical trials. The author talks about a Boston-area company, the Harvard Apparatus Regenerative Technology (HART’s) that is planning to begin scaling up the manufacturing of synthetic organs here in the United States for patients in a clinical trial. In addition, Hart already has a similar project underway in Russia and there are also plans to expand this technology in the European Union later this year. This highly experimental technology using synthetic organs will be put to the test in patients, a promising sign for the over 120,000 people currently on waiting lists for an organ in the United States according to the Department of Health and Human Services.
The technology that is being employed is quite elegant. The author describes how researchers begin by developing synthetic scaffolds of an organ and then proceed to grow cells upon this scaffold. The scaffold is rotated in an incubator for two days as the cells rain down on it and eventually cover its surface. Like the infrastructure that holds up a wall, the scaffold functions as a base upon which cells can grow and form their attachments. The major benefits of using such a technique is that it allows researchers to use a patient’s own cells, derived from their bone marrow, eliminating the need for anti-rejection drug therapy. It also eliminates the need to wait for a suitable donor trachea since the tracheas are synthetic; thus, providing the medical community with a solution to the seemingly inexorable problem of supplying the demand for suitable donors.
Once the cells are confluent upon the scaffold’s surface, the synthetic organ can then be implanted into a patient. The clinical trial will be a single arm, open-label study, meaning that there will be no control group of patients being used to compare the treatment to the standard of care. Outcomes of the trial are going to be measured principally on the basis of survival. Since the first transplant of a regenerated airway in 2008 and the world’s first transplant of a regenerated airway using a scaffold in 2011, this clinical trial stands to be another major milestone in the field of regenerative medicine. A milestone which Joseph Vacanti, a surgeon-scientist at Massachusetts General Hospital and a leader in the field of tissue-engineering was quoted as saying that, “the only way we are going to meet that real need is to manufacture living organs.”
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