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:
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.
Talaris announces FDA clearance of IND for Phase 1/2a trial of FCR001 in rapidly progressive diffuse scleroderma.
Talaris launches Phase 3 FREEDOM-1 trial of FCR001 in living donor kidney transplant recipients at Centers of Excellence around the U.S.
Talaris wins the Xconomy Big Idea award for 2019.
Regenerex relaunches as Talaris with $100 million financing and expanded leadership team, to advance FCR001 through multiple later-stage clinical trials.
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.
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.
FDA awards Regenerative Medicine Advanced Therapy designation — the cell therapy equivalent of “breakthrough designation” — to FCR001.
Novartis announces disbanding of its Cell & Gene Therapies Unit, resulting in return of all rights to FCR001 to Regenerex.
Phase 2 clinical trial of FCR001 completes enrollment of 37 LDKT patients.
FDA grants Orphan Drug Designation to FCR001 for prevention of organ rejection in LDKT.
Dr. Ildstad elected to National Academy of Inventors.
Regenerex partners with Novartis to advance trials of FCR001.
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.
First FCR001-dosed LDKT patient is weaned off all immunosuppression. He remains immunosuppression-free.
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.
Dr. Ildstad founds Regenerex to bring Facilitating Cell therapies into clinical trials.
The Institute for Cellular Therapeutics relocates from Philadelphia to Louisville and begins construction of a cutting-edge cell processing center
Dr. Ildstad elected to Institute of Medicine (now National Academy of Medicine).
Dr. Ildstad forms the Institute for Cellular Therapeutics academic research center in Philadelphia and continues characterizing the function of Facilitating Cells
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
Dr. Suzanne Ildstad begins research into cellular therapies at the University of Pittsburgh