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Peoria, Illinois – An experimental man-made tracheal implant procedure to save the life of a two-year old child was successful, officials from the Children’s Hospital of Illinois and BioSpherix announced at a news conference held April 30, 2013.
Patient Hannah Warren, now 32 months old, suffered from a life-threatening condition known as tracheal agenesis, a rare congenital condition that causes the underdevelopment or absence of a trachea in newborns. According to the Hospital, Hannah – unable to breathe, talk, swallow, eat or drink on her own since birth – would have died without a trachea transplant. Before the operation, Hannah spent her entire life in a neonatal intensive care unit in Seoul, South Korea.
The Peoria medical team successfully implanted a new synthetically bioengineered trachea during the groundbreaking nine-hour operation on April 9, 2013. While the procedure has only been performed six times in the world, this was the first in the United States and the first for a small child with a congenital defect.
According to the hospital, the procedure virtually eliminates the chance of her immune system rejecting the transplant because no donor organ was used. The trachea was grown using the patient’s own cells.
“The BioSpherix XVIVO barrier isolator system for cells was the answer to our prayers. 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,” said Dr. Mark Holterman, Professor of Surgery and Pediatrics at University of Illinois College of Medicine at Peoria and co-surgeon on Hannah’s case.
BioSpherix’s XVIVO System was crucial to the production of the engineered trachea in that it enabled doctors to manufacture Hannah’s new trachea completely within the patient surgical suite where it was implanted. The next best alternative, a Chicago-based clean room located more than 150 miles from Peoria, would have introduced a great deal of risk, requiring two just-in-time air transports of live cells and tissue. First the patient’s stem cells would have to be flown from Peoria to Chicago, and then, once produced, the sensitive man-made trachea would have to be flown back to the Children’s Hospital in Peoria.
“Our unique equipment enables FDA compliant cell production right in the operating room,” said Randy Yerden, owner and CEO of BioSpherix.
“This proves regenerative medicine can take place in any hospital,” Yerden continued. “Aspiring cell therapists are no longer dependent on the limited number of multi-million 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.”
BioSpherix, a manufacturer of advanced biomedical laboratory equipment, donated the use of their flagship XVIVO System for the experimental procedure. XVIVO is the first and only barrier isolator cell production system optimized for cells, and aligns closely with all the latest regulatory guidance.
The system was delivered, installed and validated within weeks, an unprecedented speed in the annals of cell manufacturing facilities.
Cell therapy promises significant benefits to millions who suffer from untreatable and devastating diseases. The compact mobile XVIVO System now opens up these new therapies to virtually any clinic that gets FDA approval.
The XVIVO System offers academic, research, pharmaceutical and biotechnology organizations improved control of process, contamination and quality, and indicates the future of how all valuable cells will eventually be incubated and processed.
Using XVIVO cell production system, cells are produced in a series of flexible, modular interconnected chambers with full integration of all instruments and processing tools inside. Cells and supplies enter at one end, waste is expelled aseptically along the way, and clinical grade cell product emerges at the end of the process.
Globally, there are nearly one hundred XVIVO Systems in use today including at the Roswell Park Cancer Institute (United States), University of Bordeaux (France), Ottawa Health Research Institute (Canada), Hong Kong University (China), Euroimplant Laboratories (Poland), Cleveland Clinic Foundation (United States), University of Texas, MD Anderson Cancer Center (United States), University of Linkoping (Sweden), Queen Mary, University of London (United Kingdom), Monash University (Australia) and the University of Sao Paulo (Brazil).
BioSpherix, Ltd., located in Lacona, NY, develops, manufactures and sells advanced laboratory and clinical equipment for the purpose of controlling and maintaining optimal conditions for mammalian cells outside the body, called “Cytocentric” cell incubation and processing equipment. Since its founding in 2001, BioSpherix, Ltd. has provided its unique enabling equipment to academic, research, pharmaceutical and biotechnology organizations throughout the world, for use in the fields of cell biology and stem cell research, cell therapy, gene therapy, clinical studies and FDA compliant cell production.
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