16 September 2026 editorial review · Item
Donor islet transplant (Lantidra / donislecel): 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: FDA SBRA and label directly checked: Lantidra approval used UIH-001/UIH-002 (30 participants), distinct from CIT-07 (48). Added primary citations and explicit separation. FDA reports 21 insulin-independent for at least one year, 10 beyond five years, 90% with a serious adverse reaction and two deaths during follow-up. Corrected bleeding/liver-complication denominator from infusions to recipients (13%). Removed unsupported numerical annual access ceiling.
- Registry NCT00434811: COMPLETED; updated 2019-07-17; enrollment 48 (ACTUAL); primary completion 2012-09 (ACTUAL); results not posted in retrieved record.
- Registry NCT04786262: RECRUITING; updated 2026-09-01; enrollment 57 (ESTIMATED); primary completion 2027-12-31 (ESTIMATED); results not posted in retrieved record.
- Registry NCT00679042: ACTIVE_NOT_RECRUITING; updated 2026-04-06; enrollment 21 (ACTUAL); primary completion 2017-07-19 (ACTUAL); results posted.
- Primary publication/regulatory sources checked or consulted: download; download; PMID 41219164; fda-approves-first-cellular-therapy-treat-patients-type-1-diabetes; PMID 27208344; PMID 40544428; TXD.0000000000001960.