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

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.

Timeline

Start

2008-03

Primary completion

2023-03

Completion

2023-04

Outcome

Outcome not reported

Stopped (Enrollment): “living donor kidney program terminated due to slow pace of phase 3 study enrollment”

Publications

• Leventhal JR, Galvin J, Ison MG, Feng CY, Ding R, Lee JR, Li C, Mathew JM, Gallon L, Gibson M, Belshe D, Tollerud DJ, Gornstein E, Suthanthiran M, Ildstad ST. Evaluation of Immunocompetence and Biomarkers of Tolerance in Chimeric and Immunosuppression-free Kidney Allograft Recipients. Transplantation. 2023 Oct 1;107(10):e257-e268. doi: 10.1097/TP.0000000000004666. Epub 2023 Sep 25.
• Gallon L, Mathew JM, Bontha SV, Dumur CI, Dalal P, Nadimpalli L, Maluf DG, Shetty AA, Ildstad ST, Leventhal JR, Mas VR. Intragraft Molecular Pathways Associated with Tolerance Induction in Renal Transplantation. J Am Soc Nephrol. 2018 Feb;29(2):423-433. doi: 10.1681/ASN.2017030348. Epub 2017 Nov 30.
• Leventhal JR, Elliott MJ, Yolcu ES, Bozulic LD, Tollerud DJ, Mathew JM, Konieczna I, Ison MG, Galvin J, Mehta J, Badder MD, Abecassis MM, Miller J, Gallon L, Ildstad ST. Immune reconstitution/immunocompetence in recipients of kidney plus hematopoietic stem/facilitating cell transplants. Transplantation. 2015 Feb;99(2):288-98. doi: 10.1097/TP.0000000000000605.

Drugs

Indications