Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT02008851
Status:
TERMINATED
Last Update Posted:
2014-12-11
First Post:
2013-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 1, Open-label Safety Study of NKA in Patients With Type 2 Diabetes
Sponsor:
Tengion
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: