drugset / Trial / NCT02525263
Autologous Neo-Kidney Augment (NKA) in Patients With Type 2 Diabetes and Chronic Kidney Disease (CKD)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Neo-Kidney Augment | Cell therapy | 10 ml | Other |