Clinical Trials

Our FREEDOM-1 clinical trial

Later this year, Talaris is preparing to initiate FREEDOM-1, a multi-site, Phase 3 clinical trial of FCR001 for Living Donor Kidney Transplant tolerance.

Our Clinical Trials in Living Donor Kidney Transplant

Our Phase 3 study follows a long-term, Phase 2 clinical study in living donor kidney transplant recipients. In our Phase 2 study, 70% of subjects who received FCR001 therapy in combination with a living donor kidney transplant were able to stop taking all immunosuppressive drugs by twelve months following their transplant. To date, every patient who was taken off immunosuppression has stayed off immunosuppression, without evidence of organ rejection.

To learn more about our Phase 2 results, click here.

On the basis of our Phase 2 clinical data, FCR001 has received Regenerative Medicine Advanced Therapy (RMAT) designation from FDA. The RMAT designation was created under the 21st Century Cures Act in December 2016. It recognizes promising clinical data for new cell-based therapies that address an unmet need, and enables drug sponsors to have early and frequent interactions with FDA about the drug’s development, as well as the potential for an accelerated approval pathway.

Once our Phase 3 clinical study is active, information about it will be available on www.clinicaltrials.gov. These will be some of our key eligibility criteria to participate in the FREEDOM-1 trial:

  • Transplant recipient is at least 18 years old
  • First time kidney transplant from a living donor
  • Donor’s kidney is a match to the recipient (based on blood-type and other standard kidney transplant matching criteria)
  • Donor is willing to undergo standard mobilization and apheresis procedures to donate his/her stem cells
  • Recipient has low panel reactive antibodies (PRA<20%)
  • Recipient does not have donor-specific antibodies

If you would like to be included on updates about our progress, or to be considered for the FREEDOM-1 trial once the trial is open, please complete the form below.