A Saga University research team is aiming to start in summer of this year at the earliest a clinical study involving the transplantation of blood vessels made with a three-dimensional bioprinter into patients receiving hemodialysis.
The team, which is led by organ regeneration researcher Prof. Koichi Nakayama of the university, has submitted an application to begin the study to a judging committee designated by the central government.
The transplantation of body tissues produced by a 3-D bioprinter is thought to be without precedent in the world.
Bioprinters can produce three-dimensional body tissue. In conventional regenerative medicine, transplantation involves individual cells and sheet-shaped body tissue. It is hoped that 3-D bioprinters will be able to produce tissues and organs with more complicated shapes, advancing the field of regenerative medicine.
In the study plan, a 3-D bioprinter developed by Nakayama, Tokyo-based medical equipment start-up Cyfuse Biomedical K.K. and others will be used.
Researchers will cultivate skin cells to produce cell chunks that will become the raw material for the generated tissue.
The researchers then thread the cell chunks onto thin, long needles lined like pin holders in accordance with 3-D data of blood vessels.
The cells stick together within several days, forming blood vessels about five centimeters long and six millimeters in diameter after the pins have been removed.
The researchers will transplant the produced blood vessels into three to five patients receiving hemodialysis.
If shunts, or resin pipes to remove blood from the body, are inserted into patients’ arms for a long period of time, the inside of the shunts become clogged and the blood does not flow smoothly.
The researchers aim to improve the flow by replacing the shunts with blood vessels.
The team will examine the safety and effectiveness of the method for six months.
Nakayama said: “Blood vessels made from patients’ own cells have no rejection and are less likely to cause infectious diseases compared to shunts. They can also repair themselves if holes from injections are made.
The cells are scheduled to be processed in a facility in Gamagori, Aichi Prefecture. The study plan is being screened by a government-designated committee on specific regenerative medicine that is located in Gamagori City Hospital.
The clinical study is supported by the Japan Agency for Medical Research and Development.
Prof. Makoto Nakamura of the University of Toyama’s Faculty of Engineering, an expert on regenerative medical engineering, said, “We hope the clinical study will make the development of 3-D bioprinters in the nation progress further.”
■ 3-D bioprinter
The device automatically layers cells based on digital data and makes three-dimensional tissue. While conventional 3-D printers make objects using plastic as source material, 3-D bioprinters use a mixture of cells and collagen or liquid containing cells.