Chronic Kidney Disease Clinical Trial
Official title:
A Phase 1, Open-Label Safety and Delivery Optimization Study of an Autologous Neo-Kidney Augment (NKA) in Patients With Chronic Kidney Disease (CKD)
The primary purpose of this study is to assess the safety and optimal delivery of the Neo-Kidney Augment (NKA) when implanted at one site in a recipient kidney. NKA is made from expanded autologous, homologous, selected renal cells (SRC) obtained from the patient's kidney biopsy.
Therapeutic intervention with NKA is intended to delay the need for renal replacement therapy (dialysis or transplant) which at this time, is inevitable in patients with CKD. NKA is composed of autologous, homologous selected renal cells (SRC) formulated in a Biomaterial (gelatin-based hydrogel). SRC are the biologically active component of NKA. Proof of principle for SRC as the biologically active component of NKA was established in multiple models of CKD. Based on nonclinical efficacy and safety data, a single NKA dose will be delivered to patients in this FIH clinical trial. This dose provides a minimum of a 1.5-fold safety margin over doses delivered safely in nonclinical studies. In addition, this dose demonstrated efficacy in a nonclinical disease model. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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