NCT02008851

A Phase 1, Open-label Safety Study of NKA in Patients With Type 2 Diabetes

A Phase 1, Open-Label Safety and Tolerability Study of an Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Tengion · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine if selected renal cells, obtained by biopsy from a patient with chronic kidney disease (CKD) and Type 2 Diabetes (i.e., autologous cells) can be safely implanted back into the patient.

Detailed description

This is a Phase 1 safety and tolerability study to determine if NKA, manufactured from a patient's renal biopsy tissue, can be safely implanted back into the kidney of the patient. Patients must have CKD and Type 2 Diabetes.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
BIOLOGICAL	Neo-kidney augment	Injection of 3.0 x 10e6 selected renal cells into the left kidney of the patient

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2013-12-11
• Last updated: 2014-12-11

Locations

5 sites across 1 country: United States