About the
FREEDOM trials
As you may know, people living with a kidney transplant are required to take immunosuppressive medicines (also known as anti-rejection medicines) every day for the rest of their lives following kidney transplant surgery.
Immunosuppressive medicines are used to help prevent the immune system from rejecting the new kidney. However, immunosuppressants come with their own issues. Often, several medicines need to be taken multiple times throughout the day and side effects may be difficult to manage.
FCR001 is an investigational stem and immune cell-based product that comes from your kidney donor’s blood. The intent of the investigational cell therapy is to create a dual immune system, meaning your body may accept both your and your donor’s cells. This could allow your immune system to recognize the newly transplanted kidney as its own without needing immunosuppressive medicines.
FCR001 is given as a one-time infusion.
Could you take part?
Take a short survey to find out if you could qualify for one of the FREEDOM clinical trials.
What happens in each clinical trial is a little different
FREEDOM-1
FREEDOM-1 is for people who will receive a kidney transplant from a living kidney donor (who is also willing and eligible to take part).
Recipient and donor pairs will be randomly assigned to one of two study groups: the treatment (investigational cell therapy) or control (standard-of-care) group. Participants will know which group they have been assigned to before the kidney transplant.
Two out of three recipient/donor pairs will be assigned to the treatment group.
The trial will last for about five years for all kidney transplant recipients.
Participants who receive the investigational cell therapy will have at least 34 total study visits.
Participants who receive the standard of care will have at least 21 total study visits.
FREEDOM-2
FREEDOM-2 is for people who have received a kidney transplant from a living kidney donor (who is also willing and eligible to take part) 3 to 12 months before the screening visit.
This is an open-label trial, which means that all recipients will receive the investigational cell therapy. There is no placebo in this trial.
The trial will last for about five years for all kidney transplant recipients.
Recipients will have at least 33 total study visits.
Understanding stem cell transplants
Before receiving the stem cell transplant, recipients in the treatment group of FREEDOM-1 and all recipients in FREEDOM-2 will undergo the following procedures:
Mobilization
A treatment that stimulates the stem cells in your bone marrow to enter your blood stream. You will receive filgrastim, a medicine used to mobilize your stem cells, as a subcutaneous injection (under the skin).
Apheresis
A procedure that collects your stem and immune cells after mobilization using an intravenous (IV) catheter. Apheresis takes about four to six hours, but you may have to come to the hospital the day before to have the apheresis catheter inserted.
Your cells are collected in case your body doesn’t accept your donor’s cells and you need to be given back your own cells.
Conditioning
A process of administering conditioning medicines (through a vein in your arm) and a single low dose of radiation to prepare you for the stem cell transplant. Conditioning allows your body to accept your donor’s cells.
Conditioning medicines will be administered for three days. Then, you will receive one low dose of radiation (lasting about 30 minutes) two days before your stem cell transplant.
The study team will discuss all procedures with you and answer any questions you may have.
Find your site
To learn if either of these trials could be a good fit for you, contact a site near you. If there are no locations near you, check back again soon. More may be available in the future.
Could you take part?
Take a short survey to find out if you could qualify for one of the FREEDOM clinical trials.
Talk with your doctor about FREEDOM
Download this e-Guide to help inform conversations with your healthcare provider.
