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Our History
Our Founder, Dr. Suzanne Ildstad, has spent much of her career researching and developing novel approaches to induce immune tolerance in organ transplant recipients, and to enable safer, allogeneic stem cell transplant procedures between mismatched donor-recipient pairs. Over the course of this journey, many additional dedicated scientists, clinicians, and patients have helped us get to where we are today, and we have benefited from funding and other critical support from a number of sources, notably including the National Stem Cell Foundation. Some highlights below:
2021
Talaris rings the NASDAQ closing bell to commemorate the company’s initial public offering.
2020
Talaris Therapeutics Closes $115 Million Series B Financing to support ongoing Phase 3 registration trial of Talaris’ lead product candidate FCR001 in living donor kidney transplant.
2020
Talaris announces FDA clearance of IND for Phase 1/2a trial of FCR001 in rapidly progressive diffuse scleroderma.
2019
Talaris launches Phase 3 FREEDOM-1 trial of FCR001 in living donor kidney transplant recipients at Centers of Excellence around the U.S.
2019
Talaris wins the Xconomy Big Idea award for 2019.
2019
Regenerex relaunches as Talaris with $100 million financing and expanded leadership team, to advance FCR001 through multiple later-stage clinical trials.
2018
Full results of FCR001 Phase 2 clinical study first disclosed at a scientific conference. 26/37 (70%) of LDKT patients were able to be durably removed from all chronic immunosuppression and FCR001 was generally well-tolerated.
2018
A kidney transplant recipient in the FCR001 Phase 2 study, off immunosuppression medications for 5 years, gives birth to a healthy, full-term baby girl.
Late 2017
FDA awards Regenerative Medicine Advanced Therapy designation — the cell therapy equivalent of “breakthrough designation” — to FCR001.
Late 2016
Novartis announces disbanding of its Cell & Gene Therapies Unit, resulting in return of all rights to FCR001 to Regenerex.
2016
Phase 2 clinical trial of FCR001 completes enrollment of 37 LDKT patients.
2016
FDA grants Orphan Drug Designation to FCR001 for prevention of organ rejection in LDKT.
2014
Dr. Ildstad elected to National Academy of Inventors.
2013
Regenerex partners with Novartis and National Stem Cell Foundation to advance trials of FCR001.
2012
Results of first 8 LDKT patients from Phase 2 clinical trial are published in Science Translational Medicine. Editorial refers to achievement of durable immune tolerance as a ‘Holy Grail’ of transplant.
2010
First FCR001-dosed LDKT patient is weaned off all immunosuppression. He remains immunosuppression-free.
2008
Regenerex initiates Phase 2 clinical trial of FCR001 in living donor kidney transplant (LDKT) patients. The trial ultimately recruits 37 patients at Northwestern University and Duke University.
2002
Dr. Ildstad founds Regenerex to bring Facilitating Cell therapies into clinical trials.
1998
The Institute for Cellular Therapeutics relocates from Philadelphia to Louisville and begins construction of a cutting-edge cell processing center
1997
Dr. Ildstad elected to Institute of Medicine (now National Academy of Medicine).
1996
Dr. Ildstad forms the Institute for Cellular Therapeutics academic research center in Philadelphia and continues characterizing the function of Facilitating Cells
1990
Dr. Ildstad discovers and first characterizes the Facilitating Cell, a cell type that acts as a nurse cell to nurture stem cells in the bone marrow
1988
Dr. Suzanne Ildstad begins research into cellular therapies at the University of Pittsburgh