No Need to Hold One’s Breath: Company Creates First Artificial Trachea


(DGIwire) — Regenerative medicine—especially the area of stem cell research—is regularly in the news for its role in replacing human cells, tissues and organs in ways that restore normal function. It might sound like science fiction, but scientists around the world have been experimenting with stem cells for many life-saving applications.

Why would scientists need to grow organs in a laboratory if they can obtain replacements from donors? Organ donation is a complex arena. With a typical organ donation, the patient will have to take strong immunosuppressive drugs after the transplant, just so that the body will accept the new organ. There is also an enormous shortage of organ donors, so waiting for an organ can take months or years.

Now that regenerative medicine has made strides, there’s great interest in what regenerative medicine will be able to do in coming years. One company at the forefront of this quest is Harvard Apparatus Regenerative Technology, Inc., headquartered in Holliston, MA. Harvard Apparatus is a clinical-stage regenerative medicine company developing regenerated organs for transplant. Their first product, the InBreath Airway Transplant System, is also the first application of regenerative medicine techniques to the production and transplant of complex, three-dimensional human organs like the trachea. It is intended to restore the structure and/or function of a severely damaged airway.

The InBreath system is comprised of a synthetic, porous plastic scaffold made in the size and shape of a patient’s natural trachea, bronchus or tracheobronchial tree, as well as a rotating bioreactor used to seed the patient’s own bone marrow cells onto the scaffold prior to implant. Surgeons can use the InBreath System to create a replacement trachea for patients who need an airway transplant. InBreath bioreactor technology has already been used in eight human airway transplant surgeries; the most recent surgeries used the third-generation synthetic scaffold. Harvard Apparatus recently filed pre-Investigational New Drug (IND) meeting documents with the U.S. Food and Drug Administration.

As David Green, CEO of Harvard Apparatus, explains, “We are focused on developing treatments that help surgeons address trachea cancer and other life-threatening conditions requiring GI tract, heart or lung transplant.”

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