A Safety and Efficacy Study of FCR001 vs Standard of Care in de Novo Living Donor Kidney Transplantation (FREEDOM-1)

Overview

About this study

The purpose of this study is to assess the safety, effectiveness, and overall benefit of FCR001 cell therapy in de novo living donor renal transplantation.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Main Inclusion Criteria:

- Recipient age ≥18 years.

- Donor age ≥18 and ≤60 years at time of signing informed consent.

- Recipients of a first or second living donor kidney transplant

- Donor willing to undergo mobilization, apheresis and 12-month safety follow-up and
meet all local standard eligibility criteria to donate stem cells for allogeneic
transplantation.

- Recipient meets all local standard eligibility criteria for allogeneic stem cell
transplant.

- Donors must be deemed eligible as per the requirements of 21CFR1271.

Main Recipient and Donor Exclusion Criteria:

- Recipient and donor who are identical twins.

- Recipient or donor with history of malignancy or premalignant syndrome (e.g.,
myelodysplastic syndrome, monoclonal gammopathy of renal significance [MGRS],
monoclonal gammopathy of unknown significance [MGUS]) of any organ system (other than
localized basal cell carcinoma of the skin or in-situ cervical cancer), treated or
untreated, within the past 5 years, regardless of whether there is evidence of local
recurrence or metastases.

- Recipient or donor with known bone marrow aplasia.

Main Recipient-only Exclusion Criteria:

- Multi-organ or stem cell transplant recipient.

- Calculated panel reactive antibodies >80%.

- Recipient is blood type ABO incompatible with donor.

- Presence of donor-specific antibodies (DSA) (positive result) at any time
pre-transplant.

- Recipient who is human immunodeficiency virus (HIV), hepatitis B surface antigen
(HBsAg) or hepatitis C virus (HCV) positive.

- Recipient with any baseline condition requiring or anticipated will require chronic or
intermittent use of systemic steroids or other IS (eg, autoimmune disease, asthma)
throughout the course of the study.

- Recipient with a BMI < 18 or > 35 kg/m2.

- Recipient requiring systemic anticoagulation, (eg, for hyper-coagulation disorders,
deep vein thrombosis, atrial fibrillation) that cannot be temporarily interrupted
which would preclude renal biopsy.

Main Donor-only Exclusion Criteria:

- Biologically unrelated (i.e., no genetic relationship) female donor transplant to male
recipient.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 11/17/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Mark Stegall, M.D.

Closed for enrollment

Jacksonville, Fla.

Mayo Clinic principal investigator

Martin Mai, M.D.

Closed for enrollment

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Hasan Khamash, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Additional contact information

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