NCT01649388 (FREEDOM-2) is a Phase 2 clinical trial of FCR001 in Kidney Transplantation, sponsored by Talaris Therapeutics Inc..

Who is sponsoring NCT01649388?

NCT01649388 is sponsored by Talaris Therapeutics Inc..

What drugs are being tested in NCT01649388?

Interventions in NCT01649388: FCR001.

What condition does NCT01649388 study?

NCT01649388 studies Kidney Transplantation.

Is NCT01649388 still recruiting?

NCT01649388 is currently withdrawn. Last updated 2 March 2023.

Last reviewed 2023-03-02 · How we verify

NCT01649388: FREEDOM-2

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Safety and Efficacy Study of FCR001 Cell Therapy in Previously Transplanted Living Donor Kidney Recipients

Withdrawn Phase 2 Last updated 2 March 2023

What this trial tests

Phase 2 trial testing FCR001 in Kidney Transplantation. Withdrawn.

Timeline

15 October 2012

Primary endpoint
28 February 2023

28 February 2023

Quick facts

Lead sponsor	Talaris Therapeutics Inc.
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Start date	15 October 2012
Primary completion	28 February 2023
Estimated completion	28 February 2023
Sites	3 locations across United States

Drugs / interventions tested

FCR001 — full drug profile →

Conditions studied

Kidney Transplantation — all drugs for Kidney Transplantation →

Sponsor

Talaris Therapeutics Inc. — full company profile →

Who can join

18 and older, any sex, with Kidney Transplantation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

An open-label study to assess the safety, tolerability, and efficacy of FCR001 cell therapy in adult recipients 3-12 months after kidney transplantation from a living donor.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Stem/Stromal Cells for Treatment of Kidney Injuries With Focus on Preclinical Models.
Torres Crigna A, Daniele C, Gamez C, Medina Balbuena S, et al · · 2018 · cited 38× · PMID 29963554 · DOI 10.3389/fmed.2018.00179
Tolerance Induction Strategies in Organ Transplantation: Current Status and Future Perspectives.
Blein T, Ayas N, Charbonnier S, Gil A, et al · · 2025 · cited 2× · PMID 41127478 · DOI 10.3389/ti.2025.14958

Verify or expand the search:

Other trials of FCR001

Trials testing the same drug.

NCT03995901 — A Safety and Efficacy Study of FCR001 vs Standard of Care in de Novo Living Donor Kidney Transplantation · Phase 3 · terminated

Other recruiting trials for Kidney Transplantation

Currently open trials in the same condition.

NCT07275632 — The Effects of Vonoprazan Fumarate on DGF Incidence in DD Kidney Transplant Recipients · Phase 1, PHASE2 · recruiting
NCT06568549 — Reduced Immunosuppression in Older Renal Transplant Recipients With Trugraf®/TRAC Monitoring (RIOT Trial): A Prospective · Phase 4 · recruiting
NCT06829719 — TTV-based mAnagement Of Long-term ImmunosuppreSsion in Kidney Transplantation · NA · recruiting
NCT07316829 — TRAnscriptional Profile of Peripheral Blood Cells in Patient With Chronic Kidney and Lung Rejection: Correlation With Re · active not recruiting
NCT06886256 — Prehabilitation for Kidney Transplant Candidates · NA · recruiting

Other Talaris Therapeutics Inc. trials

Trials by the same sponsor.

NCT03995901 — A Safety and Efficacy Study of FCR001 vs Standard of Care in de Novo Living Donor Kidney Transplantation · Phase 3 · terminated
NCT02084121 — Allogeneic Stem Cell Transplantation for the Treatment of Multiple Sclerosis (Compassionate Use) · no longer available
NCT02051673 — Induction of Donor-Specific Tolerance in Recipients of Live Donor Stem Cell Infusion (Compassionate Use) · no longer available
NCT02021266 — Single Patient Expanded Access Protocol: Metabolic Boost · no longer available

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01649388 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Talaris Therapeutics Inc.
Last refreshed: 2 March 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01649388.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing