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 30 year journey, many additional dedicated scientists, clinicians and patients have helped us get to where we are today. Some highlights below:

1988

Dr. Suzanne Ildstad begins research into cellular therapies at the University of Pittsburgh

 

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

1996

Dr. Ildstad forms the Institute for Cellular Therapeutics academic research center in Philadelphia and continues characterizing the function of Facilitating Cells

1997

Dr. Ildstad elected to Institute of Medicine (now National Academy of Medicine).

1998

The Institute for Cellular Therapeutics relocates from Philadelphia to Louisville and begins construction of a cutting-edge cell processing center

2002

Dr. Ildstad founds Regenerex to bring Facilitating Cell therapies into clinical trials.

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.

2010

First FCR001-dosed LDKT patient is weaned off all immunosuppression. He remains immunosuppression-free.

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.

2013

Regenerex partners with Novartis to advance trials of FCR001.

2014

Dr. Ildstad elected to National Academy of Inventors.

2016

FDA grants Orphan Drug Designation to FCR001 for prevention of organ rejection in LDKT.

2016

Phase 2 clinical trial of FCR001 completes enrollment of 37 LDKT patients.

Late 2016

Novartis announces disbanding of its Cell & Gene Therapies Unit, resulting in return of all rights to FCR001 to Regenerex.

Late 2017

FDA awards Regenerative Medicine Advanced Therapy designation — the cell therapy equivalent of “breakthrough designation” — to FCR001.

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.

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.

2019

Talaris logoRegenerex relaunches as Talaris with $100 million financing and expanded leadership team, to advance FCR001 through multiple later-stage clinical trials.