More information on the FREEDOM trials

Frequently asked questions about the FREEDOM-1 and FREEDOM-2 clinical trials

How long do these clinical trials last?

Recipients should expect to be enrolled in the FREEDOM-1 and FREEDOM-2 trials for about five years and up to one year for donors.

What resources are available if a recipient needs a donor?

For more information on finding a donor for potential recipients in FREEDOM-1, please visit National Kidney Foundation's Living Donations page.

How is the investigational cell therapy administered?

The investigational cell therapy is administered as a one-time infusion. If you would like more information, please email

Are there any data on the investigational cell therapy?

Studies are currently in progress. In a phase 2 study of FCR001 in living donor kidney transplants, 70% of participants were able to stop taking immunosuppressive medicines one year after their transplant. Participants are still being monitored for long-term safety. For more information, visit our solid organ transplantation page.

What are the benefits of taking part in the FREEDOM trials?

By contributing to this research, participants have the opportunity to help advance the future of living donor kidney transplants. The study team will discuss all potential trial-related benefits and risks with participants before they decide to take part.

What are the risks of taking part in the FREEDOM trials?

It is important to note that participants may experience side effects and/or health complications from the medicines, investigational cell therapy, and/or assessments and procedures. The study team will discuss all potential trial-related benefits and risks with participants before they decide to take part. All side effects and/or health complications should be immediately reported to the study team so they can monitor participant health and safety.

Do participants have to pay for anything?

Study-related costs for recipients and donor participants may be covered. Study participants may still be responsible for any co-pays associated with visits. The study sponsor will cover the cost of immunosuppressive medicines, if needed, for up to five years following the stem cell transplant.

Recipients and donors (plus their potential companions) may be reimbursed for travel (airfare, mileage, or other forms of public transportation), hotel/lodging, and meal expenses. There are limits to how much can be reimbursed. The study team will discuss all options with you.

Download these files for more information on reimbursement.

Can participants start the trial but then change their minds?

Yes. As with all clinical trials, participation is voluntary, and participants are free to leave these trials at any time and for any reason. Those who decide not to take part will not be penalized or lose any benefits to which they are entitled. Participants will also remain under your care for all non-study–related needs.

Could your patient participate?

Video resources

Talaris YouTube Channel

Talaris Vimeo

FCR001, an Investigational Cell Therapy: Harnessing the Power of Immune Tolerance in LDKT for HCP

An introduction to the investigational allogeneic cell therapy product called FCR001.

Downloadable resources

Explore information to help guide you through the FREEDOM trials and kidney donation.

FREEDOM-1 and FREEDOM-2 Clinical Trial Travel and Reimbursement Policy

An overview of the FREEDOM-1 and FREEDOM-2 travel and reimbursement policy. The study team will discuss all options with potential participants.

Could your patient participate?