2012 DRMRP Investigator Vignette

Title: Transportable Blood Treatment System

Investigator: Raymond Goodrich, PhD; Terumo BCT

What we've really done in our approach is utilize a photochemical process which has a basic principle of carrying out nucleic acid based chemistry that leads to inactivation of pathogens that might be present in blood. Over the years, the Military has been involved in a number of aspects of blood research. The Military blood program actually goes back quite some time and the issue is always the supply at the locations where the blood is actually needed, the logistics of being able to supply blood in those settings in the time frames where it's required.

In the last several years, there have been observations that have been made that using fresh whole blood drawn from personnel who are located in these areas in theater actually provides better support than using component therapy, which are the individual components that might be collected in a civilian setting and transported into the field.

There are great advantages in terms of morbidity and mortality in patients who are treated with that process but it also carries with it some risks. A lot of times it doesn't go through the same testing regimens or the same leuco reduction regimens, the same gamma radiation regimens, that might be used to treat blood products that are collected in the United States.

And so the desire has been to develop a process that would be able to do multiple of these individual procedures in one setting with one procedure and allow that transfused blood to be the safest blood possible, collected locally, being used in patients who receive it in the field.

What we're doing is utilizing a process that assumes that the blood is contaminated when it comes in and we use a photochemical agent. What's unique about our process is the photochemical that we use. It's riboflavin or vitamin B-2 something that's found commonly in foods that we ingest on a routine basis. But when you take riboflavin and you add it at certain concentrations in the blood products and expose it to UV light at particular wavelengths, it carries out a chemistry in the blood that inactivates the nucleic acids that are present in these pathogens.

Viruses, bacteria, parasites, white blood cells are all very different in their structure and composition but the one thing that they have in common is the presence of nucleic acid. And the one thing that they require in order to transmit disease are nucleic acids. So by inactivating or preventing replication processes, we're able to destroy the ability of those pathogens to transmit disease.

White blood cells going from a donor to a recipient can cause graft versus host disease and that's where donor white blood cells actually start attacking the tissue in the recipient. So if you shut down the replication process of those white blood cells, you prevent that from occurring or having the potential to occur. Red blood cells, platelets, which are involved in blood clotting, and plasma proteins, which are also involved in blood clotting, they don't contain nucleic acid. So this chemistry, which inactivates the pathogens, leaves the blood components relatively alone and maintains their therapeutic efficacy when they're transfused.

Today the product has been approved and is used with success with a variety of blood products including platelets and plasma in countries outside the United States. It's commercially available. It's used in routine in Europe, parts of the Middle East, and Africa. The support that we've received from CDMRP has allowed us to advance the program for whole blood in the United States. We've done a variety of preclinical testing which has been used to support applications to the Food and Drug Administration and allowed us to proceed to the first stages of human research in the United States clinical research that's required in order to have the FDA approve the product.

We've completed our first phase one clinical study and that data has been reported in the medical literature, and we're now advancing with FDA approval to our second phase of clinical research in the United States. And we hope within the next several years this program will be completed with again, the support that we're receiving from CDMRP and the consortium of researchers that we've been able to put together with this program, advance it through FDA approval and eventual fielding of the device in the routine setting for the Military as well as for civilian-the civilian population as well.