What exactly is regenerative medicine? It’s the branch of medicine that develops methods to regrow, repair or replace damaged or diseased cells, organs or tissues and has been called the "next evolution of medical treatments" by the U.S. Department of Health and Human Services.

Regenerative medicine at Wake Forest University School of Medicine is housed within the Wake Forest Institute for Regenerative Medicine (WFIRM), led by Anthony Atala, MD, director of WFIRM and professor of urology. Physicians and scientists at WFIRM were the first in the world to engineer laboratory-grown organs that were successfully implanted into humans. Thanks to continuous advancements, impactful grants and partnerships with high-level organizations around the world, it is recognized as an international leader in translating scientific discovery into clinical therapies.

Collaboration is Key

This innovative specialty requires a multidisciplinary approach that involves teamwork and active collaboration across almost every department, making them the subject matter experts in bioprinting, tissue engineering, and cell and gene therapy. This interdisciplinary team includes approximately 400 individuals working to engineer more than 40 different replacement tissues and organs, and to develop healing cell therapies – all with the goal to cure, rather than merely treat, disease.

Connective Tissue

These vast partnerships bridge internal collaborations among almost all departments of the Atrium Health enterprise, as well as heavy-hitting projects with NASA, the Department of Defense, the Department of Health and Human Services and several arms of the military.

Over the past decade, the institute has held leadership roles in both phases of the Armed Forces Institute of Regenerative (AFIRM) research program, leading to 25 clinical trials and several hundred patients who received treatment with AFIRM-funded technologies. With $250 million in funding overall, AFIRM has been a results-focused program and 20 consortium-supported projects have resulted in commercial partnerships, including start-up companies, to advance product development.

Other large funded programs include a unique $24 million federally-funded project to develop a "body on a chip" and then received an additional $24 million to continue that research with “lung on a chip” that have been used to model the body's response to harmful chemical and biological agents and develop potential treatments. This past summer, WFIRM received a $36 million award from the Defense Threat Reduction Agency, a part of the Department of Defense, that will enable it to establish a research and development program to provide early warning data related to deadly viral threats.

WFIRM has received grant funding from NASA for several projects, but most recently two teams of institute scientists won first and second place in NASA's 2021 Vascular Tissue Challenge – a prize competition that aims to accelerate tissue engineering innovations and strategies for making tissues with artificial blood vessels. The research will help inform future efforts to vascularize tissue for human clinical use someday while also potentially accelerating pharmaceutical testing and disease modeling. The ability to create engineered organs developed from a patient’s own cells so there will be no risk of rejection or the need for anti-rejection drugs has the potential to help end the organ shortage. The tissue models can be used to study how radiation exposure affects the human body for developing strategies to mitigate damage.

Two people in lab coats having a discussion while looking at medical equipment.

Innovation Accelerator

Locally, WFIRM has springboarded efforts to create a sustainable regenerative medicine business landscape in Winston-Salem, North Carolina, with the Regenerative Medicine Hub. The Hub draws upon the resources and talent available throughout the Innovation Quarter and includes regenerative medicine-focused entities such as the RegenMed Development Organization and the national headquarters for the Regenerative Manufacturing Innovation Consortium, as well as a regenerative medicine test bed, innovation accelerator and workforce development program.

According to Atala, “with Wake Forest University School of Medicine as the academic core of Atrium Health and our extension all the way to Charlotte and beyond, we are creating an innovation corridor with powerhouse potential.”

Engineering the Next Generation

With its ongoing commitment to sharing discoveries, WFIRM leads continuing education and internship opportunities with various programs for summer scholars, National Institutes of Health pre-doctoral training opportunities and a visiting international scholars program, as well as partnerships bridging the spectrum of practical application from an internship for Forsyth Technical Community College to a graduate degree with the Virginia Tech – Wake Forest University School of Biomedical Engineering and Sciences.

The School of Medicine is collaborating with regenerative medicine experts at WFIRM to create a new master’s degree program to prepare next and future generations of STEM professionals and business leaders for the regenerative medicine field.

Anthony Atala, MD “As we develop these technologies, it’s very important that we keep our clinical endpoint in mind and, therefore, we are constantly working with our clinician partners to ensure we’re answering their needed challenges that we can help find a solution to. Our role is to create teams to bring these technologies to life so we can get them to patients and make their lives better.”- Anthony Atala, MD, Director of WFIRM

Evolution of Medical Treatment

With its potential to heal, regenerative medicine is expected to revolutionize healthcare. Through advanced collaboration and progressive partnerships, WFIRM is moving the needle to improve patients' lives by developing regenerative medicine therapies and supporting technologies. WFIRM is focused on multiple research programs that are working to develop replacement tissues and organs while speeding up the availability of these treatments to patients.

Now that Wake Forest University School of Medicine has become the academic of core of Atrium Health, WFIRM has an even more robust network of hospitals to collaborate with which widely extends the footprint of technological impact for patients.