Biomaterials
results gives more robust data moving into patients.” In regard to safety, the team conducted thorough testing on haemocompatibility due to concerns about possible clotting. In vitro, in vivo and organ pathology studies demonstrated that the material did not increase clotting or result in emboli in other areas of the body. The team plans to conduct further extensive testing as a precaution, although they do not anticipate any issues.
The amount of muscle tissue damaged during myocardial infarction can be prognostic of a patient’s quality of life as well as the potential for heart failure.
In both the rat and pig MI models, the researchers observed reduced oedema in the heart, reduced inflammatory cells, improvements in survival with cardiomyocytes (the cardiac muscle cells) and increased density of blood vessels – all of which led to significant improvements in cardiac function. In the mouse model of traumatic brain injury and rat model of pulmonary arterial hypertension, the researchers saw the iECM also targeted the leaky vasculature at sites of inflammation. “This was an exciting development,” Christman reiterates. “The ability of the iECM to target leaky vasculature in inflamed tissues and treat the microvasculature across different species and injury models suggests that it could be applied to a lot of different conditions and has led us to explore different clinical applications, such as severe Covid- 19, where there is overactive systemic inflammation and leaky vasculature. The iECM can be delivered intravenously and then it will circulate in the body and target the areas where you have inflamed vasculature,” she explains.
Clinical human trials are imminent The first human clinical trials of iECM in MI’s are expected to be up and running within one to two years, and there are hopes that the other clinical applications will follow in the near future. Christman is confident that the research results will translate in humans: “I think we’re optimistic that this will translate well,” she says. “There’s no guarantee, of course, moving from animal to patients, but extracellular matrix is fairly conserved among species and pig is pretty close to human. So, the fact that we’ve done lots of different species in both old and young animals and are seeing very consistent
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Furthermore, tests indicated that the material is rapidly eliminated from animal bodies through typical secretion channels, such as urine, with some minor metabolism occurring in the liver. “So far, all indications for safety are good, but we will continue to do some additional safety checks and dosage testing before clinical trials,” says Christman. “The material itself is derived from porcine material, which has a very good safety profile in patients, but you would want to avoid the very small number of patients who have a porcine allergy,” she adds. In the case of MI, iECM would be given as a single dose delivered at the same time as other treatments, and the hope is that those suffering from a heart attack would benefit. “They’re not going to have a brand-new heart. It’s not going to be back to normal, but they’ll basically be at a better baseline with less damage and improved function, and that would equate to a better quality of life,” says Christman. “They’ll feel better. They’ll be able to do more with improved cardiac function and it will hopefully prevent heart failure from eventually occurring.” She points out that cost is a major advantage over alternative methods. “There is a big benefit to using a biomaterial as opposed to other regenerative therapeutics, like cells or growth factors,” she explains. “Depending on the indication, we are looking at a few thousand dollars per patient, as opposed to a cell therapy which can be tens of thousands of dollars, if not $100,000.”
So, how long before we might see iECM as a routine medical treatment in heart attacks? “It would require a phase I, II and III clinical trial – so you are looking at least five to seven years to go through that full process before you would get full approval, and that would likely be the same for the other indications once they start the process,” says Christman, who is working with Ventrix Bio – the company she co-founded more than a decade ago to develop the original ECM hydrogel – to move the iECM into clinical trials. “We think iECM is definitely a very new platform for treating damaged or inflamed tissues in a very easy, simple, minimally invasive manner,” Christman says. “It has taken over a lot of my lab and spurred a lot of new research. It is definitely one of the more exciting projects because of all the new clinical applications, and new collaborations, that this has started.” ●
Medical Device Developments /
www.nsmedicaldevices.com
Explode/
Shutterstock.com
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