New hope is brewing that Clemson University researchers could develop the first treatment to reverse the effects of a cardiovascular condition that affects millions of patients and can lead to complications ranging from hypertension to death.

Naren Vyavahare, the Hunter Endowed Chair of Bioengineering, is receiving $2.2 million from the National Institutes of Health to further research into his team’s potentially heart-saving treatment.

Naren Vyavahare is among the bioengineering faculty members from Clemson University to win R01 awards from the National Institutes of Health.

Naren Vyavahare is among the bioengineering faculty members from Clemson University to win R01 awards from the National Institutes of Health.

His approach could be the first to reverse vascular calcification, a condition that occurs when mineral deposits build up on blood vessel walls and stiffen them. The condition is most prevalent in aging patients and those with chronic kidney disease and type 2 diabetes, Vyavahare said.

“The impact of an effective treatment would be tremendous,” Vyavahare said. “This is a problem that’s at least 5,000 years old and still not solved. There are no drugs or therapies that reverse it. Ours would be the first.”

Vyavahare and his team are creating nanoparticles that are made of the protein albumin and are many times smaller than the width of a human hair. The nanoparticles would deliver two medicines to calcified blood vessels, targeting damaged elastin.

Elastin is the body’s version of elastic material, making it possible for arteries to push blood forward.

One medicine, disodium ethylenediamine tetraacetic acid (EDTA), would remove the mineral deposits that cause blood vessels to become calcified. Another medicine, pentagolloyl glucose (PGG), would return elasticity to the blood vessels.

What makes the nanoparticles especially innovative is that they are designed to target elastin that has degraded and calcified, while sparing healthy arteries. A relatively small amount of EDTA would be needed to treat vascular calcification.

Without the nanoparticles, systemic injections of EDTA require high dosages that result in unwanted side effects, such as hypocalcemia, renal toxicity and bone loss.

The research is funded through the National Institutes of Health R01 program. Researchers at the University of South Carolina– John Eberth, Mohamad Azhar and Susan Lessner–are collaborating on the project.

Vyavahare said the technology could be ready for clinical human trials by the end of the four-year grant period. A company he has formed, Elastin Therapeutics, has licensed the patented the technology from Clemson, he said.

Martine LaBerge, chair of the Department of Bioengineering, said that Vyavahare is highly deserving of the grant.

“This is the latest of many high-profile grants that Dr. Vyavahare has received,” she said. “His hard work and unique approach continue to advance health innovation at Clemson and beyond.”

The vascular calcification targeted in Vyavahare’s study differs from atherosclerosis.

Atherosclerosis is associated with calcification of a site in the vessel wall known as the intima. Vyavahare’s research focuses on a different site in the vessel wall called the media.

Calcification of the media can happen independently of atherosclerosis.

Vyavahare’s research could be a game-changer for some patients. Medial calcification has been linked to elevated systolic blood pressure and pulse pressure. It also contributes to isolated systolic hypertension.

Patients with chronic kidney disease are more likely to die from cardiovascular complications than kidney failure. In patients with type 2 diabetes, medial calcification was associated with a four-fold increased risk for lower extremity amputation and two-fold enhanced cardiovascular mortality.

“Unfortunately, there is no FDA-approved treatment available that reverses calcification in these millions of patients,” Vyavahare said. “Thus, finding treatments that reverse calcification and improve elasticity of arteries is an urgent healthcare challenge.”

Anand Gramopadhye, dean of the College of Engineering, Computing and Applied Sciences, congratulated Vyavahare on the grant.

“Dr. Vyavahare’s research is aimed at one of the greatest challenges of the 21st century– engineering better medicines,” he said. “With his latest grant and impeccable credentials, he is well positioned to develop new medicines with the potential to ease suffering and save lives.”