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Cell Therapy

FCR001 for Transplant Rejection (FREEDOM-1 Trial)

Phase 3

Waitlist Available

Research Sponsored by Talaris Therapeutics Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up month 1 (post transplant) to month 6, 12, 24, 36, and 60

Awards & highlights

FREEDOM-1 Trial Summary

This trial will test a new cell therapy to see if it is safe and effective in people who are getting a kidney transplant from a living donor.

FREEDOM-1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ month 1 (post transplant) to month 6, 12, 24, 36, and 60

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~month 1 (post transplant) to month 6, 12, 24, 36, and 60

This trial's timeline: 3 weeks for screening, Varies for treatment, and month 1 (post transplant) to month 6, 12, 24, 36, and 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of FCR001 recipients who are free from immunosuppression (IS), without biopsy proven acute rejection (BPAR) at 24 months post-transplant

Secondary outcome measures

Allograft function (eGFR by MDRD4) and change in eGFR from Month 1 to Month 24, 36, and Month 60, by treatment

Allograft function (eGFR) and change in renal allograft function from Month 1 to Months 24, 36 and 60 by treatment group, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula

Categorical distribution of eGFR according to chronic kidney disease CKD staging classification by treatment

+30 more

FREEDOM-1 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FCR001Experimental Treatment1 Intervention

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.

Group II: ControlActive Control1 Intervention

Standard induction therapy followed by a maintenance regimen of tacrolimus, mycophenolate, and +/- corticosteroids after kidney transplant. Control donors are not followed beyond randomization.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Talaris Therapeutics Inc.Lead Sponsor

11 Previous Clinical Trials

87 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Across how many different geographical locations is this clinical trial being conducted?

"Currently, there are 18 hospitals and clinics running this clinical trial. In addition to Durham, Portland and Omaha, the other cities with sites include _____. To minimize travel time and effort, patients are encouraged to select the site nearest them for participation in the study."

Answered by AI

Are people with the relevant medical condition still being recruited for this research project?

"That is accurate. Presently, the clinical trial detailed on clinicaltrials.gov requires new participants. This specific study was first made public on October 25th, 2019 and was last updated less than a week ago on October 26th, 2020. In total, 18 different medical centres are involved in this trial and 240 patients are needed for completion of the study."

Answered by AI

How many people are taking part in this trial at most?

"In order to successfully complete this clinical study, 240 participants that meet the inclusion criteria are required. The sponsor, Talaris Therapeutics Inc., will administer the trial from various locations; two of these sites include Duke University Medical Center and Oregon Health & Science University."

Answered by AI

What is the most severe reaction that patients have had to FCR001?

"FCR001's safety is estimated to be a 3. This is based on the fact that it is a Phase 3 trial, so while there isn't extensive data supporting efficacy, there are multiple rounds of data indicating that it is safe."

Answered by AI

Recent research and studies

TransplantationJournal

Tolerance Induction in HLA Disparate Living Donor Kidney Transplantation by Donor Stem Cell Infusion

Leventhal, Joseph, Michael Abecassis, Joshua Miller, Lorenzo Gallon, David Tollerud, Mary Jane Elliott, Larry D. Bozulic, Christopher Houston, Nedjema Sustento-Reodica, and Suzanne T. Ildstad. 2013. “Tolerance Induction in HLA Disparate Living Donor Kidney Transplantation by Donor Stem Cell Infusion”. Transplantation. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/tp.0b013e3182782fc1.

TransplantationJournal

Immune Reconstitution/immunocompetence in Recipients of Kidney Plus Hematopoietic Stem/facilitating Cell Transplants

Leventhal, Joseph R., Mary J. Elliott, Esma S. Yolcu, Larry D. Bozulic, David J. Tollerud, James M. Mathew, Iwona Konieczna, et al.. 2015. “Immune Reconstitution/immunocompetence in Recipients of Kidney Plus Hematopoietic Stem/facilitating Cell Transplants”. Transplantation. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/tp.0000000000000605.

Science Translational MedicineJournal

The Quest for Transplantation Tolerance: Have We Finally Sipped from the Cup?

Markmann, James F., and Tatsuo Kawai. 2012. “The Quest for Transplantation Tolerance: Have We Finally Sipped from the Cup?”. Science Translational Medicine. American Association for the Advancement of Science (AAAS). doi:10.1126/scitranslmed.3003678.

Science Translational MedicineJournal