First-in-Class Phase 3 Clinical Trial Candidate Rilparencel Expresses Nephron Markers and Acquires Glomerular Epithelial and Tubular Features
Bibliographic record
Abstract
Background: Kidney cortical administration of rilparencel, a biopsy-derived autologous kidney epithelial cell platform, improves glomerular, tubular and urine concentrating profiles in chronic kidney disease (CKD) models & may support kidney function in type 2 diabetes (T2D)&CKD patients. We tested the hypothesis that rilparencel expresses markers spanning the nephron & acquires glomerular epithelial & tubular features. Methods: Banked rilparencel samples from 5 T2D&CKD patients (NCT02836574) were analyzed with scRNAseq & kidney cell types & states identified with unsupervised clustering & projection on to the KPMP single cell CKD atlas. Organoids from rilparencel were grown for up to 17 d, sectioned & stained with periodic acid Schiff. Human rilparencel (discarded kidneys, NDRI) organoids in 3D culture were immunofluorescent antibody stained for nephron & glomerular epithelial precursors, HOXA11 & PTPRO (GUDMAP ATLAS-D2K), respectively, tubular epithelial markers, LTL & CD13 & the cycling cell marker, CDC6. Results: KPMP-anchored molecularly profiled cell types constituting rilparencel include glomerular parietal epithelial cells (PECs), adaptive proximal tubules (PTs), ascending thin limb (ATL) & adaptive thick ascending limb-2 (TAL-2), distal convoluted tubule (DCT), connecting tubule (CNT) & intermediate collecting duct (IMCD). Proportions of each cell type were consistent amongst samples. Immunoflourescent antibody staining confirmed nephron & glomerular epithelial precursors, tubular epithelium & cycling cells. Sectioning of rilparencel organoids revealed morphologic features consistent with glomerular epithelium & tubules. Conclusion: An integrated, cross-validating approach indicates that rilparencel expresses markers spanning the nephron & acquires glomerular epithelial & tubular features in culture. Increased nephron mass with both functional compartments may underlie beneficial effects of cortical delivery of rilparencel. Funding: Commercial Support - ProKidney
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.001 | 0.003 |
| Insufficient payload (model declined to judge) | 0.012 | 0.003 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".