A biomaterial injected intravenously has potential application in heart attacks, traumatic brain injury and more. Because it can be injected intravenously, the biomaterial can be administered immediately following a heart attack, rather than the current standard of days or a week. The team is filing for human clinical trials to begin in less than 2 years.
Researchers at the University of California San Diego have created a biomaterial that can be injected intravenously to reduce inflammation in tissue and promote cell and tissue repair. The material has potential applications in treating heart attacks, traumatic brain injury, pulmonary arterial hypertension and more.
The new biomaterial is based on previous work by Karen Christman, a professor of bioengineering at the University of California San Diego, and her team. Initially, the researchers developed a hydrogel made from the natural scaffolding of cardiac muscle tissue that could be injected into damaged heart muscle tissue via a catheter. Results from a successful phase 1 human clinical trial were reported in fall 2019. However, because the hydrogel needs to be injected directly into heart muscle, it could only be used a week or more after a heart attack—sooner would risk causing damage because of the needle-based injection procedure.
In this study, published in Nature Biomedical Engineering, Christman and her team wanted to develop a treatment that could be administered immediately after a heart attack. They started with the hydrogel, which by then was proven safe, but the particle size was too big to target leaky blood vessels.
The team solved this issue by putting the liquid precursor of the hydrogel through a centrifuge, which allowed for sifting out bigger particles and keeping only nano-sized particles. The resulting material was put through dialysis and sterile filtering before being freeze-dried. Adding sterile water to the final powder results in a biomaterial that can be injected intravenously or infused into a coronary artery in the heart.
They then tested the biomaterial on a rodent model of heart attacks. According to the study, the biomaterial bound to endothelial cells, closing the gaps and accelerating healing of the blood vessels, and reducing inflammation. Tests using a porcine model of heart attack had similar positive results.
The team also successfully tested the hypothesis that the same biomaterial could help target other types of inflammation in rat models of traumatic brain injury and pulmonary arterial hypertension.
Now, Christman’s lab will undertake several preclinical studies for these conditions. In the meantime, they are planning to ask the FDA for authorization to conduct a study in humans of the new biomaterial’s applications for heart conditions. This means human clinical trials could begin as soon as one or two years from now.