Nara Medical University has announced the production of artificial red blood cell preparations and the implementation of Phase I clinical trials ("Investigator-initiated clinical trials of artificial red blood cell preparations that can be stockpiled and administered urgently"). The aim is to overcome critical bleeding that is difficult to administer by transfusion by administering artificial red blood cell preparations.

 Even in Japan, where the blood donation and transfusion system is highly safe, there are situations where it is difficult to supply transfusion products to injured or sick people who are in critical bleeding. In remote island and remote area medical care, pre-hospital care, nighttime emergency care, emergency surgery sites, large-scale natural disasters, terrorism, and emergencies, there is a need for a large demand and rapid supply of blood for transfusions.

 Artificial red blood cells (hemoglobin vesicles, HbV) are microparticles encapsulating purified concentrated Hb solution, and are produced from unused red blood cells (discarded blood) generated after blood donation. They are regenerated into artificial red blood cell products that do not contain infectious agents and have no blood type, and can be stored for a long period of time.

 For the three-year period from 6 to 8, the investigational drug will be manufactured at Nara Medical University Hospital, and an investigator-initiated Phase Ib clinical trial will be conducted on a small number of healthy adults, with the primary objective of evaluating the tolerability* and pharmacokinetics of increasing the dosage volume and administration rate from 3 to 800 mL, toward an expected clinical dose of 100 mL.

 After tolerability has been confirmed, the drug will proceed to Phase II clinical trials to confirm efficacy and safety. A trial protocol has been proposed for installing the drug on doctor's cars and doctor's helicopters, in anticipation of treating patients with anemia due to gastrointestinal bleeding in remote areas and on islands, and in pre-hospital critical bleeding.

 It is expected that in the future, this preparation will be introduced to countries with inadequate blood donation and transfusion systems, used as a preservation solution for organs for transplantation, as an antidote for cyanide poisoning caused by oxidants (methionine), and as an alternative to blood transfusions in the veterinary field. If it is put into practical use, it will revolutionize the entire medical system and contribute to improving the health and welfare of the nation.

*Editor's note: Severity of side effects

reference:[Nara Medical University] Manufacture of artificial red blood cell preparations that can be stockpiled and administered in emergencies, and conduct phase I clinical trials at Nara Medical University Hospital (PDF)

Nara Medical University

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