A Record of Firsts

Achievements of Institute scientists include engineering replacement tissues and organs in all four categories: flat structures, tubular tissues, hollow organs and solid organs.

  • First to demonstrate that complex, layered tissue structures can be engineered using cells. (1994)
  • Developed the first tissue-engineered product to go to the U.S. Food and Drug Administration for Phase 1 approval for clinical applications, consisting of cells and biomaterials for injectable therapy. (1995)
  • First to use biomaterials alone, without addition of cells, implanted in patients for the regeneration of organs. (1996)
  • First to create a laboratory-grown organ — engineered bladder tissue (hollow organ) that was successfully implanted in patients. (1999 first implantation; publication 2006)
  • First to create a functional experimental solid organ, a miniature kidney that secretes urine. (2003)
  • Led the team that engineered tubular organs (urine conduits) and implanted them in patients.
    (2004 first implantation; publication 2011)
  • Founded the Regenerative Medicine Foundation, a non-profit organization dedicated to the advancement of regenerative medicine treatments and therapies. (2005)
  • Proved feasibility of printing living tissue structures to replace injured or diseased tissue in patients. (2006)
  • Identified and characterized a new source of stem cells derived from amniotic fluid and placenta, which show promise for the treatment of many diseases. (2007)
  • Selected to co-lead the Armed Forces Institute of Regenerative Medicine, an $85 million, federally funded effort to apply regenerative medicine to battlefield injuries. (2008)
  • Started the first initiative for regenerative medicine manufacturing, through the establishment of a joint industrial engineering program (2008), and the Regenerative medicine Manufacturing Society. (2016)
  • First to engineer functional experimental solid organs (penile tissue and livers) using a strategy to recycle donor organs, with potential applications to other solid organs, such as the kidney and pancreas. (2009 and 2010)
  • Led the team that implanted engineered vaginas into four girls with a rare genetic defect. (2005 first implantation; publication 2014)
  • Selected to lead the second phase of the Armed Forces Institute of Regenerative Medicine (AFIRM II), a $75-million project (2013)
  • Developed a 3D bioprinter (the Integrated Tissue and Organ Printing System) over a 14-year period specifically designed to print living tissue structures. (publication 2016)
  • Developed a highly functional body-on-a-chip platform that integrates multiple normal human cell derived tissues with a common “blood” supply system for drug toxicity testing and personalized medicine. (2017)
  • Developed miniature 3D human brains (organoids), the first engineered tissue equivalent to naturally resemble the normal human blood brain barrier, containing all six major cell types found in organs. (publication 2018)
  • Developed an engineered uterus that can sustain pregnancy and live delivery pre-clinically. (publication 2020)
  • WFIRM team won 1st and 2nd place in the NASA Vascular Tissue Challenge, creating vascularized liver tissues with two different 3D bioprinting methods. (2021)