Abstract: FR-PO0236
Metabolic Transition During Manufacturing of Rilparencel, a Kidney Cell Therapy Candidate
Session Information
- CKD: Mechanisms of Injury and Fibrosis - 2
October 23, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: CKD (Non-Dialysis)
- 2203 CKD (Non-Dialysis): Mechanisms
Authors
- Greenawalt, Ashley, ProKidney LLC, Winston-Salem, North Carolina, United States
- Rohlfing, Mark A., ProKidney LLC, Winston-Salem, North Carolina, United States
- James, Katherine Sholtis, ProKidney LLC, Winston-Salem, North Carolina, United States
- Bruce, Andrew T., ProKidney LLC, Winston-Salem, North Carolina, United States
- Justewicz, Dominic Mark, ProKidney LLC, Winston-Salem, North Carolina, United States
Background
Rilparencel is an autologous renal cell therapy currently in Phase 3 clinical trials for the treatment of CKD patients with Type 2 diabetes mellitus (T2DM). Multiple lines of evidence suggest the importance of renal metabolomics in characterizing tubular epithelial cell health. This is the first study to report on metabolic changes during rilparencel manufacturing.
Methods
We conducted an extracellular metabolites analysis at two key timepoints during manufacturing of rilparencel for 17 patients enrolled in two Phase 2 investigative clinical trials of T2DM and stage 3-4 CKD (n=5, NCT02836574; n=12, NCT05018416) and a NDRI Stage 2 CKD donor kidney (n=1; National Disease Research Interchange). Cells taken at early manufacturing (T1) and at Final Product (FP), were incubated for 24 hours and conditioned-media was collected for untargeted metabolomics (LC-MS) and pathway analysis along with relevant controls. To identify significant differences in metabolite levels between early manufacturing and FP null hypothesis testing (one-way ANOVA) was conducted on all profiled metabolites, using T1 as the reference group.
Results
Overall, 2,215 metabolites were measured, and 986 were confidently identified. Principal Component Analysis demonstrated clear clustering of samples by time point, demonstrating a specific metabolic signature that evolves during manufacturing (A). The NDRI sample only clustered at FP. Several key differences suggest a shift in pathways related to membranes, lipid rafts and/or cell signaling; purine metabolism; and altered methylation in FP (B).
Conclusion
Our findings suggest that the rilparencel product may reflect a metabolic transition among renal epithelial cells during manufacturing.
Acknowledgment
Untargeted metabolomics analysis performed by PanomeBio.
Secreted metabolites were analyzed from rilparencel harvested at two time points in manufacturing (T1, FP). A demonstrates distinct clustering between manufacturing time points for all samples (except for the NDRI sample at T1). B shows enriched pathways in FP with a significance threshold (p = 0.05) denoted by the grey dashed line.
Funding
- Commercial Support – ProKidney LLC