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Stem Cell Therapy

FCR001 for Kidney Transplant (FREEDOM-2 Trial)

Phase 2
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 from infusion to 12 months, 24 months and 60 months
Awards & highlights

FREEDOM-2 Trial Summary

This trial will test how safe and effective a cell therapy is in adults who have recently had a kidney transplant from a living donor.

FREEDOM-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from infusion to 12 months, 24 months and 60 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from infusion to 12 months, 24 months and 60 months 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 FCR recipients (FCR-R) who are free from immunosuppression (IS), without biopsy-proven acute rejection (BPAR), at 24 months post-FCR001 infusion
Secondary outcome measures
Change in renal allograft function over time by CKD-EPI
Change in renal allograft function over time by MDRD4
Change in renal function (estimated Glomerular Filtration Rate [eGFR] by Modification of Diet in Renal Disease [MDRD4]) from baseline (Day 1, prior to FCR001 infusion) to Month 24 in FCR recipients
+12 more

FREEDOM-2 Trial Design

1Treatment groups
Experimental Treatment
Group I: FCR001Experimental Treatment1 Intervention
Recipients 3-12 months post-living kidney transplantation undergo non-myeloablative conditioning followed by infusion of an enriched hematopoietic stem cell product derived from the same living donor's peripheral blood stem cells

Find a Location

Who is running the clinical trial?

Talaris Therapeutics Inc.Lead Sponsor
11 Previous Clinical Trials
102 Total Patients Enrolled
Suzanne T Ildstad, M.D.Study DirectorTalaris Therapeutics Inc.
1 Previous Clinical Trials
9 Total Patients Enrolled
Ken Abrams, MDStudy DirectorTalaris Therapeutics
2 Previous Clinical Trials
37 Total Patients Enrolled

Frequently Asked Questions

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

What potential hazards are associated with FCR001?

"Based on our assessment, FCR001 is ranked a 2 for safety due to the preclinical data that confirms its security but lacks evidence of effectiveness in Phase 2."

Answered by AI

Is enrollment currently open for this medical experiment?

"As per the clinicaltrials.gov database, this medical experiment is actively seeking participants since it was initially posted on October 15th 2012, and has been revised recently on October 26th 2022."

Answered by AI

How extensive is the participant pool for this clinical experiment?

"This clinical trial, which is sponsored by Talaris Therapeutics Inc., necessitates the recruitment of 15 individuals who meet its set criteria. The research will be conducted at various sites including University of Minnesota Medical Center in Minneapolis, Minnesota and Georgetown University Hospital in Washington, District of Columbia."

Answered by AI

Is eligibility for this clinical trial limited to persons younger than 45 years of age?

"This research study is open to individuals aged 18 and over, but below the age of 65."

Answered by AI

What is the eligibility criteria for participation in this medical experiment?

"To participate in this trial, 15 individuals should have functioning renal organs and lie between 18-65 years of age."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Safety and Efficacy Study of FCR001 Cell Therapy in Previously Transplanted Living Donor Kidney Recipients
2012. "A Safety and Efficacy Study of FCR001 Cell Therapy in Previously Transplanted Living Donor Kidney Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01649388.
~0 spots leftby Apr 2025
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