Triad emerging as national hot spot for regenerative medicine

Many of the latest breakthroughs in helping the human body heal itself can be found in downtown Winston-Salem.

That’s where the Wake Forest Institute for Regenerative Medicine, as well as a partner economic development organization, the Regenerative Medicine Engine, are working to advance their specialty field of developing therapies that help the human body repair its tissue – and even generate new organs.

“The challenge is that every 30 seconds, a patient dies from diseases that could be treated with tissue replacement,” said Anthony Atala, M.D., director of WFIRM and chair of urology at Wake Forest University School of Medicine. “Wouldn’t it be great if we could just regenerate ourselves?”

Atala was speaking at WFIRM’s first-ever public day, held last month at the Wake Forest Biotech Place in downtown Winston-Salem’s Innovation Quarter. The event gave researchers, students, teachers and other members of the community an opportunity to learn more about what’s driving regenerative medicine, as well as the advances emerging from the institute.

Regenerative Medicine Engine expansion

To coincide with the event, the Regenerative Medicine Engine announced a new name and focus. Previously known as the Piedmont Triad Regenerative Medicine Engine, the organization is now focused on a statewide and national effort to boost the field.

Backed by an initial funding of $15 million from the National Science Foundation, the Regenerative Medicine Engine is the nation’s first regional ecosystem dedicated to regenerative medicine. The organization has added more than 80 partner companies and organizations to its network since launching in early 2024.

“Such strong interest showed us that there is demand for the resources we offer – from regulatory navigation to business expertise and from state-of-the-art equipment to workforce development – across the regenerative medicine industry,” Regenerative Medicine Engine CEO Tim Bertram said in a statement.

Advances in organ and tissue replacement

At WFIRM’s public day, Atala described several ways research led by the institute has made it to clinical trials.

For example, WFIRM staff have taken muscle tissue samples from a patient with a rotator cuff injury in the shoulder, expanded those cells in the laboratory, and reinserted them into the shoulder during surgery. The procedure helps the shoulder muscles regenerate, providing far greater strength and recovery to the patient.

The technology can be applied to many organs. Atala also showed images of successful regenerative procedures involving the kidneys, liver and heart, where cells are grown in the lab on structures such as scaffolds and placed back in the patient.

Atala, who led the team that developed the first lab-grown organ to be transplanted into a patient, is considered a pioneer in regenerative medicine. That recognition has helped turn WFIRM into one of the world’s leading centers for the field, with 550 employees and research into 40 different replacement tissues and organs.

“What’s occurred in the last few years is that a number of regen-med startups have been initiated in our backyard,” he said. “We’re seeing a growing intersection of biotechnology, innovation and business.”

Overcoming commercialization hurdles

The medical and scientific advances being developed in the Triad show great promise for treating a variety of conditions, including the engineering of replacement organs – a much-needed development as transplant patients often face long waiting lists before an organ becomes available.

Where challenges persist, however, is in getting new therapies to patients.

The Regenerative Medicine Engine noted that gaps in infrastructure and commercialization pathways are blocking some therapies from obtaining approvals from the U.S. Food and Drug Administration. Regenerative medicine, as a relatively new field, requires more time and effort to overcome these hurdles.

The organization said it has made recent strides, including:

• Helping Pluristyx, a Seattle-based cell therapy startup, secure a U.S. patent for an immune-evasive cell technology
• Working with Epredia, a diagnostics technology company owned by Japan-based PHC Holdings Corp., on FDA clearance of a new regenerative medicine diagnostic tool
• Attracting $174 million in investments to companies with operations in North Carolina
• Awarding $2.5 million in grants

“The national and even global interest in the Regenerative Medicine Engine validates the work we’ve been doing to help translate use-inspired research into commercial applications,” Atala said in the Regenerative Medicine Engine’s news release.

“Our commitment to the Piedmont Triad region and the state of North Carolina has not changed, as many of our offerings are still local. In fact, taking our initiatives national will only help further position the region and state as a leader in regenerative medicine and biomanufacturing.”

Nancy Johnston, executive director of the North Carolina Biotechnology Center’s Piedmont Triad Office, agreed with Atala.

"Given this NSF Engine's continued momentum, engaging this valued regional strength all across NC is an exciting and viable opportunity for expanded impact, growth and sustainability,” Johnston said.