When you support WFIRM you are supporting life-changing medical research.
Harnessing the Innate Healing Power of the Human Body
WFIRM is recognized as an international leader in translating scientific discovery into clinical therapies. A number of the basic principles of tissue engineering and regenerative medicine were first developed at the institute, and the research team has a growing list of world firsts, including the first to create lab-grown organs that were successfully implanted into patients.
WFIRM researchers have successfully engineered replacement tissues and organs in all four categories – flat structures, tubular tissues, hollow organs and solid organs. Sixteen different applications of cell/ tissue therapy technologies, such as skin,urethras, cartilage, bladders, muscle, kidney,and vaginal organs, have been successfully placed in human patients.
With experts in molecular biology, genetics,cell biology, physiology, pharmacology, biomaterials, imaging and nanotechnology, the institute has broad research capabilities. This expertise – combined with a leading-edge facility and research infrastructure that are unsurpassed– enables our scientists to pursue multiple strategies simultaneously using tissue engineering, cell therapies, diagnostics, drug discovery, biomanufacturing, nanotechnology, gene editing and 3D printing.
WE ARE…
using tissue engineering to grow replacement tissue and organs in the lab. Because a patient’s own cells can be used, there are no issues with rejection.
using cell therapies with living cells to promote healing and regeneration from within.
using organoregenesis rather than relying on cells alone. Small molecules are being studied with regard to how they can contribute to the development of effective treatments for tissue repair and regeneration.
Making Regenerative Medicine a Reality – Clinical Translation
Achieving the WFIRM mission means getting new technologies to the clinic safely and rapidly, and that requires satisfying strict U.S. Food And Drug Administration (FDA) quality and safety requirements. Once a new technology is thoroughly tested and ready for clinical studies, WFIRM is equipped for efficient “translation” from the bench to the bedside. A current good tissue practices and good manufacturing practices compliant facility, which manufactures and stores replacement tissues and organs under FDA guidelines, ensures that a reproducible process is in place. And, when the technology is ready to be used clinically, WFIRM has the unique infrastructure and resources to develop partnerships to expedite the delivery of the technology to patients.
Clinical Trial Pipeline: The 21st Century Cures Act, signed into law, is designed to help accelerate medical product development and bring new innovations and advances to patients who need them faster and more efficiently. It also established new expedited product development programs like Regenerative Medicine Advanced Therapy, or RMAT, that offers an expedited option for certain eligible biologics products.
Clinical studies for technologies developed by WFIRM scientists are ongoing or screening for patient enrollment:
© Wake Forest University School of Medicine, Bowman Gray Center for Medical Education, 475 Vine Street, Winston-Salem, NC 27101. All Rights Reserved.