Image: Patient Hannah Warren after the trachea implantation (Photo courtesy of Children’s Hospital of Illinois).
A synthetically bioengineered trachea made using the patient’s own cells has been successfully implanted in a two-year old child born with tracheal agenesis, a rare congenital condition that causes the underdevelopment or absence of a trachea in newborns.
The synthetically bioengineered trachea implantation, the first performed in the United States and the sixth the world, was completed on April 9, 2013, at the Children’s Hospital of Illinois (Peoria, USA). The trachea was synthesized using the compact mobile XVIVO System, a product of BioSpherix (Lacona, NY, USA), which offers academic, research, pharmaceutical, and biotechnology organizations improved control of process, contamination, and quality control of cell production, opening up a portal to using these new therapies in virtually any clinic.
“The BioSpherix XVIVO barrier isolator system for cells was the answer to our prayers,” said Professor of Surgery and Pediatrics Mark Holterman, MD, co-surgeon at the procedure. “Their technology allowed us to safely build a new trachea for our patient and virtually eliminated the risk of contamination and at no cost. We are very grateful to the BioSpherix team. They put their hearts into helping fix this child.”
The BioSpherix XVIVO barrier isolator cell-production system consists of modular sets of closed incubators and closed hoods all integrated together as co-chambers and subchambers. The modularity allows an infinite variety of different configurations. All are completely closed, with aseptic conditions throughout, and advanced controls wherever needed. Microscopes, centrifuges, sorters, and all other common cell tools can be integrated into one efficient system. The incubation chambers are integrated into the hoods, and open only into the hood, eliminating contamination by people or by the room.
An additional advantage is that cells never see any disruptions in critical parameters, because all cell parameters controlled in incubators are also identically controlled in hoods. Independent incubation chambers can be fitted into a system, dedicated to each different culture to accommodate any number of different culture protocols simultaneously. Basic cell parameters such as O2 are fully accounted for, and a range of exotic cell parameters can provide better simulation of physiologic conditions, with controls to keep up with the changing dynamics of any cell population.
“This proves regenerative medicine can take place in any hospital,” said Randy Yerden, owner and CEO of BioSpherix. “Aspiring cell therapists are no longer dependent on the limited number of multimillion dollar clean rooms, usually only found in large tertiary hospitals and research centers. Now other brilliant surgeons like Dr. Holterman and his team can begin engaging in organ engineering wherever they practice.”
Children’s Hospital of Illinois