NCT02560220

MIC Cell Therapy for Individualized Immunosuppression in Living Donor Kidney Transplant Recipients

A Single-arm Phase-I Trial for the Determination of Safety and Feasibility of the Intravenous Administration of Mitomycin C-treated Donor Peripheral Blood Mononuclear Cells (MICs) for Individualized Immunosuppression in Living Donor Kidney Transplant Recipients (TOL-1 Study)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Heidelberg University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A phase- I clinical trial to determine safety and feasibilty of intravenous administration of mitomycin C-treated donor peripheral blood mononuclear cells in patients with chronic kidney disease stage KDIGO 4 or 5 (i.e. GFR 15-30 mL/min or \< 15 mL/min) who receive a kidney transplant from a living donor.

Conditions

• Kidney Failure, Chronic

Interventions

Type	Name	Description
BIOLOGICAL	Mitomycin C-induced peripheral blood mononuclear cells (MICs)	MICs are given intravenously 2 or 7 days before kidney transplantation from a living donor

Timeline

• Start date: 2015-08-05
• Primary completion: 2017-04-18
• Completion: 2017-04-18
• First posted: 2015-09-25
• Last updated: 2018-07-26

Locations

1 site across 1 country: Germany