The investigational cell therapy (made from your donor’s cells) is administered as a one-time infusion. To learn more, or if you have questions, please email patientinformation@talaristx.com.

Your participation could help advance medical research for people with dcSSc. Your health will also be closely monitored by experts in dcSSc.

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. If you have any questions, please ask the study team.

• Tacrolimus: High blood pressure, which may cause dizziness, blurred vision; infection, especially when white blood cell count is low; bruising, bleeding; anemia (low red blood cell counts); kidney damage, which may cause swelling, may require dialysis; constipation, diarrhea, nausea, vomiting; diabetes; abnormal body movement; feeling of “pins and needles” in arms and legs; headache; dizziness; difficulty sleeping; swelling of body; fever; hair loss; itching, rash

• Mycophenolate mofetil (MMF): Mouth sores; anxiety; stomach pain; fever; upset stomach; tremor; difficulty sleeping; high blood pressure; diarrhea; constipation; leukopenia (low white blood cell counts), anemia; thrombocytopenia (low platelet counts); inflammation and bleeding of gastrointestinal system; edema or swelling of feet; abnormal or tingling sensations in limbs

• Corticosteroids: High blood pressure; increased eye pressure; cataract (clouding of vision); facial fullness; muscle cramps and joint pain; changes in menstruation; emotional disturbances; easy bruising and thinning of skin; increase in body hair and acne; weight gain with increased appetite and fluid retention; diabetes and suppression of body’s ability to make necessary cortisone; irritation of stomach and esophagus with rare bleeding; long-term use may increase risk of bone fractures

Filgrastim: Increase in white blood cell count; nosebleed; anemia; diarrhea; bone pain; fever; tiredness; hair loss

• Cyclophosphamide: Infection, especially when white blood cell count is low; anemia; bruising, bleeding; blood in urine; nausea, vomiting, diarrhea, loss of appetite, pain in belly; sores in mouth, which may cause difficulty swallowing; absence of menstrual period, which may decrease ability to have children; hair loss, skin changes, rash, change in nails

• Mesna: Infection, especially when white blood cell count is low; nausea, vomiting, constipation; unpleasant taste; tiredness; fever

• Fludarabine: Cough; infection, especially when white blood cell count is low; bruising, bleeding; increased risk of unusual infections lasting more than six months; vomiting, loss of appetite; tiredness
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• Conditioning medicines and radiation: Temporary decrease in number of white blood cells, red blood cells, and platelets; discomfort from lying still for a period of time; nausea; vomiting; fatigue; increased risk of cancer; early onset menopause with increased risk of bone fractures; infertility/inability to get pregnant (temporary or permanent); temporarily decreased sperm count; fever

Allergic reactions; cough; headache; dizziness; hypotension; hyperkalemia; increased blood levels of urea and creatinine

Decrease in blood calcium level leading to tingling or abnormal sensations in arms and legs and muscle spasms; joint, bone, or back pain; faintness; fluid overload; weakness; anxiety; pain or infection at site of catheter insertion; decrease in platelets increasing tendency to bleed

Pain; discomfort; localized infection; rash from anesthetic; bleeding; clotting; bruising; anaphylactic shock due to reaction of anesthetic

• GvHD affecting the skin (rash), liver (jaundice, yellow skin color), or gastrointestinal tract (diarrhea, abdominal pain or cramps); skin rashes and skin thickening; dryness or difficulty swallowing; absent or reduced ability to make tears leading to dry eyes and discomfort in bright light

• Graft failure or lack of engraftment (lack of acceptance and growth of donor stem cells in bone marrow, which means your body will not be able to produce red cells, white cells, or platelets)

• Blood type conversion (you may convert to your donor’s blood type if your blood type is different from your donor’s)

• FCR001 is an investigational cell therapy; not all of the potential side effects are known. Additionally, there may be unknown risks to a pregnancy, embryo, or fetus

No. Taking part in any clinical trial is completely voluntary.

You may stop being in the trial at any time and for any reason. Please tell your study team if you decide to leave so they can work with you to best protect your health. This might include a final visit or check of your health.

Study-related costs for recipient 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.

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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.

Participants should expect to be enrolled in this trial for about five years for recipients and about 15 months for donors.

Please talk to the study team if you need help finding a donor.