Questions
Question: What are you trying to accomplish?
Answer: The project that we're talking about is designed to create freeze-dried blood. Right now, blood is restricted to use in the hospital setting or very close to the hospital because of requirement for cold chain to take care of it as a living tissue. Unfortunately, there is a huge population of people who are bleeding outside of hospitals. People have been in accidents or who are in austere environments and don't have access to hospitals. This could be soldiers in combat. It could be people on a cruise ship. It could be people on the moon or a space station.
So right now, it isn’t appreciated that something like 20 to 30,000 people bleed to death every year in the US alone because they don't have access to blood at the point of injury or at the point of accident. So, we're creating freeze dried shelf stable blood products that medics can carry in an ambulance and reconstitute at the point of injury so that they would have instant blood and they could administer it at the scene of an accident.
Question: Why is it so difficult to create artificial blood?
Answer: First of all, there are three components to blood. It's actually a fairly complex fluid. The red blood cells that carry the hemoglobin that carries the oxygen. There's the plasma that carries the cells and provides the fluid so it's fluid. It's got to be fluid, so it flows through the circulatory system, and then there's the elements that are in plasma and platelets that helps blood clot. So, if you need a transfusion because you've been in an accident, by definition, you're bleeding. So, if you're doing something that doesn't help clotting, then that's going to be a problem. So, we have to recapitulate the system that forms blood clots but only forms them where there's a wound, not where you don't want it. We have to recapitulate plasma that keeps the blood fluid at just the right amount of viscosity. And we have to recreate the oxygen carrier. That does 2 very interesting things. It grabs the oxygen in the lung and then let's go in tissue, so those are opposite chemical events. So, these are complex processes that we have to create.
Now, evolution created them with red blood cells and platelets and plasma proteins, and that was hundreds of millions of years of evolution designed this system. So, we now have to imitate that system in a simpler way that can exist outside the body on a shelf for over a year so that the medic can give that, you know, at the scene of an accident. That's why it's been a challenge.
Question: How will we know when it’s safe?
Once there are certain requirements that are met, then you would start your human testing. The principle has always been start low, go slow so that you slowly ramp up the intensity of the treatment in you start with healthy subjects and then you will start the patient trial with a small number few doses. Then once you build that confidence then you expose and perform a large so-called phase three clinical trial in patients to mimic how the product will be used after approval. So, we will have to work with, for example, our trauma center and other trauma centers like that where we have to collaborate and recruit patients based upon the, you know, 911 calls and so on. And if the patient meets a certain inclusion-exclusion criteria, they would be enrolled into the clinical trial. And at that time the EMT professionals will be having access to this test product that they can administer to patients and they will be enrolled in the trial.