A Study of a Renal Autologous Cell Therapy (REACT) in Patients With Chronic Kidney Disease (CKD) From Congenital Anomalies of the Kidney and Urinary Tract (CAKUT).

Summary

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Description

A Renal Autologous Cell Therapy (REACT) is an injectable product composed of selected renal cells (SRC) formulated in a biomaterial (gelatin-based hydrogel). Renal cells obtained from autologous kidney biopsy tissue will be expanded and SRC selected. Selected renal cells (SRC) will be formulated in ...

A Renal Autologous Cell Therapy (REACT) is an injectable product composed of selected renal cells (SRC) formulated in a biomaterial (gelatin-based hydrogel). Renal cells obtained from autologous kidney biopsy tissue will be expanded and SRC selected. Selected renal cells (SRC) will be formulated in a gelatin-based hydrogel at a concentration of 100 x 106 cells/mL to improve stability during transport and delivery upon injection into the renal cortex. Porcine gelatin will be dissolved in buffer to form the thermally responsive hydrogel. Although fluid at room temperature, this biomaterial gels when cooled to refrigerated temperature (2 to 8ºC). Prior to injection, the REACT investigational product must be warmed to ?20° up to 26°C to liquefy the hydrogel. This sterile cell preparation (REACT) will be contained in a sterile 10 mL syringe and shipped to the clinical site for use. The dose of Renal Autologous Cell Therapy (REACT) for subjects in the Phase 1 clinical trials (TNG-CL010 and TNG-CL011) was 3 x 106 SRC /g estimated kidney weight. Similarly, in the present study, each REACT injection will contain 3 x 106 cells/g. Since the concentration of selected renal cells (SRC) is 100 x 106 cells/mL of REACT, the dosing volume will be 3.0 mL for each 100 g of kidney weight. The volume of REACT to be administered will be determined by pre-procedure MRI volumetric 3D evaluation or ellipsoid formula (Length x width AP plane x width Transverse plan x .62). It is anticipated that all subjects will receive two planned Renal Autologous Cell Therapy (REACT) injections to allow dose-finding and evaluate the duration of effects. The scientific rationale, based on non-clinical studies, is that the biologically active component of REACT (homologous, autologous, SRC) delays progression of experimental models of Chronic Kidney Disease (CKD) by augmenting renal structure and function. As a result, the more cells that can be infused, the greater the potential improvement in renal function.

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