The major challenges are the fact that the vocal fold vibrates, so that anything we make has to mimic the biomechanical properties of the vocal fold, she said. It is difficult because most biomaterials that can mimic vocal fold properties also quickly degrade, and we want the materials to stay around for a while.
Explore This IssueFebruary 2007
She is hoping that they will have a first product for FDA approval within three years.
Success of Tissue Engineering Products
According to Dr. Nussenbaum, experts from multiple disciplines will need to work together to make tissue engineering a success; these include clinical scientists, biologists, biomedical engineers, industry sponsors, and government agencies. To help expedite the developmental process and monitor both safety and efficacy, an international registry of clinical trials for tissue engineering products is now being developed by the Tissue Engineering and Regenerative Medicine International Society (TERMIS), a society formed in 2004.
Tissue engineering approaches have a great potential to benefit our patients to some degree in the future; these treatments will hopefully be performed by all otolaryngologists, and not just those in highly specialized practices, said Dr. Nussenbaum. It might be a treatment like injecting a molecule into the parotid gland of a patient with Sjögren’s syndrome to repair the organ and restore salivary production, or using regenerated cartilage derived from the patient’s own cells for a revision rhinoplasty or airway reconstruction, he said.
Although Dr. Nussenbaum feels that there is great potential for this newly developed field of medicine, there is still a great amount that we don’t know about the biologic processes that govern tissue regeneration. Dr. Nussenbaum stated that we need to avoid the hype that has been inherent to this field and concentrate efforts on well-designed clinical trials that prove safety and efficacy before proceeding with potentially very expensive and risky new procedures on patients.
Dr. Thibeault does not see tissue engineering as the answer to treatment of all disease types and conditions in the future. She does think that tissue engineering will add to the present armamentarium that will provide options for specific conditions that don’t have options right now, such as scarring of the vocal fold.
Dr. Baum, who is clinically trained as a dentist and is working on developing an artificial salivary gland, is also optimistic, albeit a bit more cautious. From my perspective, which is more focused, said Dr. Baum, I would say the field is making slow, steady progress.