16 September 2026 editorial review · Item
iTolerance iTOL-102 (SA-FasL microgel + islets): review notes
These notes document the scope actually reviewed, including source-access limits. They are not independent clinical certification or a guarantee that every claim was verified.
Read the item evidence page →Preventing and curing evidence review — 16 September 2026
- Disposition: corrected/updated. Current item
lastReviewed: 2026-09-16. - Claim check: The SA-FasL primate experiment used a small cohort and temporary rapamycin; it is not the proposed iTOL-102 stem-cell product. Removed the inference that FDA sent the company back: pre-IND consultation is not authorization. Removed the false exclusive-human-benchmark claim.
- Registry NCT03482050: COMPLETED; updated 2021-01-15; enrollment 16 (ACTUAL); primary completion 2020-06-22 (ACTUAL); results not posted in retrieved record.
- Primary publication/regulatory sources checked or consulted: sciadv.abm9881.
- Programme/sponsor/conference source boundary: Kadimastem and iTolerance Successfully Complete Pre-IND Meeting with the FDA for its Type 1 Diabetes Treatment (manufacturer); iTolerance — iTOL-100 platform and pipeline (iTOL-101, iTOL-102) (manufacturer); NLS Pharmaceutics and Kadimastem Highlight Continued BIRD Foundation Support for ITOL-102 Diabetes Program Following Merger (manufacturer).