A Safety and Efficacy Study of FCR001 vs Standard of Care in de Novo Living Donor Kidney Transplantation
NCT ID: NCT03995901
Last Updated: 2023-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
15 participants
INTERVENTIONAL
2019-10-25
2023-02-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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FCR001
FCR001 is a cryopreserved allogeneic stem cell therapy derived from mobilized peripheral blood of the kidney donor that is delivered as a single dose with a non- myeloablative conditioning regimen. FCR001 contains the donor's CD34+ cells, facilitating cells, and αβ T cells.
FCR001
FCR001 is a cryopreserved allogeneic stem cell therapy derived from mobilized peripheral blood of the kidney donor that is delivered as a single dose with a non- myeloablative conditioning regimen. FCR001 contains the donor's CD34+ cells, facilitating cells, and αβ T cells.
Control
Standard induction therapy followed by a maintenance regimen of tacrolimus, mycophenolate, and +/- corticosteroids after kidney transplant.
Control donors are not followed beyond randomization.
No interventions assigned to this group
Interventions
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FCR001
FCR001 is a cryopreserved allogeneic stem cell therapy derived from mobilized peripheral blood of the kidney donor that is delivered as a single dose with a non- myeloablative conditioning regimen. FCR001 contains the donor's CD34+ cells, facilitating cells, and αβ T cells.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
* 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.
* Biologically unrelated (i.e., no genetic relationship) female donor transplant to male recipient.
18 Years
ALL
No
Sponsors
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Talaris Therapeutics Inc.
INDUSTRY
Responsible Party
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Locations
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Mayo Clinic
Phoenix, Arizona, United States
Scripps Clinic
La Jolla, California, United States
University of California, San Francisco
San Francisco, California, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
Mayo Clinic
Jacksonville, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
The University of Michigan Hospitals & Health System
Ann Arbor, Michigan, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
New York-Presbyterian/Weill Cornell
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Oregon Health & Science University
Portland, Oregon, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Baylor University Medical Center
Dallas, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Countries
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Other Identifiers
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FCR001A2301
Identifier Type: -
Identifier Source: org_study_id
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