drugset / Trial / NCT02525263

Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease (CKD)

NCT02525263 ↗

NaSingle-groupOpen-labelTreatment

Summary

A Phase II, Open-Label Safety and Efficacy Study of an Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease (RMTX-CL001). NKA is made from expanded autologous selected renal cells (SRC) obtained from the patient's kidney biopsy. All enrolled subjects will be treated with up to two injections of NKA at least 6 months apart.

Timeline

Start
2016-07
Primary completion
2017-05
Completion
2017-08

Outcome

Outcome not reported

Stopped (Enrollment): “The single patient enrolled began hemodialysis treatments.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Neo-Kidney Augment Cell therapy 10 ml Other