About the
FREEDOM-3 trial
in the FREEDOM-3 trial.
As you may know, dcSSc progresses very quickly and affects all areas of the body.
- Internally, dcSSc may affect the blood vessels of organs such as the heart, lungs, and kidneys
- Externally, side effects may include Raynaud’s phenomenon (fingers turn white, blue, and red; “pins and needles” sensation), skin hardening (thickening), and skin fibrosis (scarring)
Currently, there is no cure for dcSSc, and it’s usually managed with immunosuppressive medicines to lower the impact of the disease and avoid or delay major health complications. Although these medicines are the standard of care for dcSSc, they can have limitations and are often not very effective—leaving people still looking for symptom relief.
The investigational cell therapy, FCR001, is an investigational stem and immune cell-based product that comes from your donor’s blood. Your donor’s cells will be collected through procedures called mobilization and apheresis in order to create FCR001.
Then, you will receive a stem and immune cell transplant with FCR001 as a one-time infusion.
The investigational cell therapy is thought to work by replacing the immune cells in the recipient's body that don't work properly with working cells from a donor who does not have dcSSc. This research will help us understand if the investigational cell therapy could potentially treat their dcSSc.
Could you take part?
Take a short survey to find out if you could qualify for the FREEDOM-3 clinical trial.
in the FREEDOM-3 trial.
Stepping into the FREEDOM-3 clinical trial
The trial will last for about five years for all recipients, which includes at least 21 to 33 study visits.
Some of these visits may coincide with routine clinic visits and care. Some visits may be able to take place at home.
This is an open-label trial, which means that all recipients will receive the investigational cell therapy.
There is no placebo in this trial.
Understanding stem cell transplants
Before receiving the stem cell transplant, recipients in FREEDOM-3 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).
You may also receive corticosteroids to help prevent a scleroderma flare from the filgrastim.
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 is used to suppress your immune system, make room for new stem cells, and allow your body to accept your donor’s cells which will remain in your bone marrow and blood.
Conditioning medicines will be administered for three days. Then, you will receive one low dose of radiation (lasting about 30 minutes) two days before the 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 this trial 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 the FREEDOM-3 clinical trial.
in the FREEDOM-3 trial.
Talk with your doctor about FREEDOM-3
Download this e-Guide to help inform conversations with your healthcare provider.
