Abstract: SA-PO0015
Longitudinal Secretome Characterization of Renal Cell Therapy Candidate Rilparencel During Manufacturing
Session Information
- Development, Stem Cells, and Regenerative Medicine
October 24, 2026 | Location: Exhibit Hall A, Convention Center
Abstract Time: 10:00 AM - 12:00 PM
Category: Development, Stem Cells, and Regenerative Medicine
- 700 Development, Stem Cells, and Regenerative Medicine
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 cell therapy currently in a Phase 3 clinical trial for the treatment of CKD patients with Type 2 diabetes mellitus (T2DM). Derived from a cortical kidney biopsy, rilparencel consists primarily of cells likely originating from renal epithelia. The secretome of a renal cell therapy product may be influenced by the manufacturing process. Here, we characterize the dynamics of the secretome during rilparencel manufacturing.
Methods
Rilparencel product was manufactured for 11 patients enrolled in two Phase 2 investigative clinical trials of T2DM and stage 3-4 CKD (n=5, NCT02836574; n=6, NCT05018416) or NDRI donor kidneys (n=4; National Disease Research Interchange). Cryopreserved cells collected during two (NCT02836574), four (NCT05018416), or five (NDRI) steps of the manufacturing process were incubated for 24 hours, and conditioned-medium was analyzed for ~ 80 CKD-related secretory proteins using commercial and custom test panels (Luminex xMAP, Intelliflex). Analysis was performed utilizing GraphPad Prism, Excel, JMP, R Studio, and Panther Go Enrichment Analysis.
Results
Secretome analysis demonstrated an evolving secretory profile of factors associated with inflammation, angiogenesis, tissue remodeling, adaptive and renoprotective tissue repair pathways during the rilparencel manufacturing process.
Conclusion
The observed trends and pathway analyses illustrate the evolution of the secretome during rilparencel manufacturing.
Representative heatmap demonstrating patterns of expression across several CKD-relevant biomarkers. The color gradient indicates the normalized quantity (pg/1K cells minus background >LLOQ for each factor) for a subset of clinical samples (n=6, NCT05018416) at each (T1, T2, T3, FP) process step within a range of 0 to 100% for each specific biomarker. Fold-changes (e.g. FP vs. T1) provide a measure of the changes in quantity (e.g., for 43 markers, 31 were <1 while 12 were >2, variability ranged 10% to >100% with average of 52%). Other clinical and donor kidney sample sets provided similar insight.
Funding
- Commercial Support – ProKidney LLC