Clinical Trials

Our FREEDOM-1 clinical trial

Talaris has launched FREEDOM-1, a multi-site, Phase 3 clinical trial of FCR001 for Living Donor Kidney Transplant tolerance.

Freedom 1 clinical study logo

Our Clinical Trials in Living Donor Kidney Transplant

Talaris is currently enrolling in the FREEDOM-1 Study, a Phase 3 clinical trial of our investigational cell therapy, called FCR001, at Centers of Excellence around the United States. The purpose of this study is to learn more about whether FCR001 can prevent the rejection of living donor kidney transplants without the need for lifelong anti-rejection drugs. It will compare the efficacy and safety of FCR001 treatment to standard anti-rejection treatment.

Find out where the study is being offered here.

To learn more about the study and determine if you are eligible to participate, click here.

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.

Information about our Phase 3 Clinical Study is available here: https://www.clinicaltrials.gov/ct2/show/NCT03995901?spons=talaris&rank=1

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