Study Details


What to expect from your study participation

Study participants and their living donors who enroll in FREEDOM-1 will be randomly assigned as a pair to either Group 1 or Group 2. You will be twice as likely to be assigned to Group 1 (FCR001) as to Group 2 (control). The Group 1 (FCR001) protocol is illustrated below.

Kidney donor donates stem cells via standard mobilization and apheresis procedure.
Kidney donor donates stem cells via standard mobilization and apheresis procedure.
Talaris’ proprietary  manufacturing process removes certain undesirable cells and enriches product for stem cells and  facilitating cells.
Talaris’ proprietary manufacturing process removes certain undesirable cells and enriches product for stem cells and facilitating cells.
Recipient undergoes three days of moderate outpatient conditioning to make space in the bone marrow for the donor’s cells to engraft.
Recipient undergoes three days of moderate outpatient conditioning to make space in the bone marrow for the donor’s cells to engraft.
Surgeon transplants the donor’s kidney into the recipient.
Surgeon transplants the donor’s kidney into the recipient.
Physician infuses FCR001 therapy into the recipient.
Physician infuses FCR001 therapy into the recipient.
Patient remains on standard immunosuppression and returns to clinic at regular intervals for routine monitoring.
Patient remains on standard immunosuppression and returns to clinic at regular intervals for routine monitoring.
Simple blood test looks to confirm that donor and recipient immune cells are coexisting in recipient’s bone marrow. If so, physician gradually lowers immunosuppression.
Simple blood test looks to confirm that donor and recipient immune cells are coexisting in recipient’s bone marrow. If so, physician gradually lowers immunosuppression.
Recipient free of all chronic immunosuppression drugs.
Recipient free of all chronic immunosuppression drugs.

How the FREEDOM-1 Study is organized

Group 1 (FCR001): FCR001 recipients will receive FCR001 cell therapy and initial anti-rejection medicines (tacrolimus–also known by the brand name Prograf® — plus mycophenolate mofetil–also known as MMF or by the brand names CellCept® or Myfortic), with withdrawal of anti-rejection medicines beginning 7 to 12 months post-transplant.

Group 2 (Control): Standard of care recipients will receive standard anti-rejection therapy administered at the time of transplant (called induction therapy) followed by daily treatment with tacrolimus (brand name Prograf®),  mycophenolate mofetil (MMF or brand names CellCept® or Myfortic), and corticosteroids (typically prednisone) for the duration of the study.

DONOR

Group 1 (FCR001)

Group 2 (Control)

3-8 weeks prior: Collection of stem cells. This involves taking “mobilization” drugs for 5 days that stimulate stem cells to enter the blood from the bone marrow followed by collection of the stem cells by a routine blood filtering procedure called apheresis No additional pre- or post-transplant activities required.
Day 0: Kidney transplant surgery Kidney transplant surgery
One year post-transplant: Follow-up period

RECIPIENT

Group 1 (FCR001)

Group 2 (Control)

3-8 weeks prior: Collection of stem cells. This involves taking “mobilization” drugs for 5 days that stimulate stem cells to enter the blood from the bone marrow followed by collection of the stem cells by a routine blood filtering procedure called apheresis
4 days prior: Conditioning with several drugs and one dose of radiation. The conditioning allows acceptance of their donor’s stem cells contained in the FCR001 cell therapy.
Day 0: Kidney transplant surgery Kidney transplant surgery
Day 1: FCR001 is dosed intravenously
0-6 months post-transplant: Take standard anti-rejection drugs and have regular doctor’s visits Post-transplant: standard of care
6-9 months post-transplant: If after the first six months a recipient’s body has accepted the donor’s stem cells, a state known as “chimerism,” anti-rejection medicines will be tapered and discontinued after month 12.
5 years post-transplant: Follow-up period 5 year follow-up