NCT00497926

Induction of Donor Specific Tolerance in Recipients of Living Kidney Allografts by Donor FCRx Infusion

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Talaris Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Research study which involves the use of a combination of an Enriched Hematopoietic Stem Cell Infusion (stem cells, produced by the bone marrow, generate the cells that form the blood elements, help fight infection and assist in clotting) and kidney transplantation from the same donor to try to avoid the need for long-term anti-rejection drug therapy. The desired result of this study is to allow the body to develop "tolerance" to the transplanted kidney. Tolerance means that the body would see the transplanted kidney as part of the patient and not try to get rid of, or reject it. To prevent rejection, drugs called immunosuppressive agents must be taken on a daily basis. The purpose of this study is to determine if this procedure is safe and to try to substantially reduce or even eliminate the need for anti-rejection medications.

Conditions

• Kidney Failure

Interventions

Type	Name	Description
BIOLOGICAL	Enriched Hematopoietic Stem Cell Infusion	Enriched Hematopoietic Stem Cell Infusion

Timeline

• Start date: 2008-03-01
• Primary completion: 2023-03-01
• Completion: 2023-04-01
• First posted: 2007-07-09
• Last updated: 2023-10-11

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study