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Gene-edited donor islet cells survived and secreted insulin without immunosuppression for 14 months in one patient

Gene-edited allogeneic pancreatic islets transplanted into the forearm muscle of one man with longstanding type 1 diabetes continued to show beta-cell function through 14 months without systemic immunosuppression. The investigators reported no detected immune response against the allograft.

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Stable ID
science-2025-gene-edited-donor-islets
Revision
science-2025-gene-edited-donor-islets.v1
Field
Medicine · Cell therapy and type 1 diabetes
Evidence
Tier 2 · Peer reviewed: Yes
Record state
Current · First-in-human proof of concept
Last checked

AI role

No substantive AI role was reported.

Record details

Problem or result
Donor islet replacement can restore insulin production, but immune rejection normally requires chronic immunosuppression.
Authors
Per-Ola Carlsson, Xiaomeng Hu, Hanne Scholz et al.
Institutions
Uppsala University; UCSF; University of Oslo and Oslo University Hospital; Karolinska Institutet; Sana Biotechnology
Result date
Initial report August 4, 2025; follow-up July 10, 2026

Why it matters

Functional donor-cell survival without immunosuppressive drugs addresses the central barrier to off-the-shelf islet replacement.

Limits

This remains a one-person, uncontrolled early-phase result using a low cell dose; the participant did not become insulin-independent. Fourteen months does not establish population-level efficacy, lifetime immune evasion, malignancy or infection safety, or performance at a therapeutic dose. The registry still lists two planned participants and has stale completion dates.

Sources

  1. Primary: NEJM primary case report
  2. Primary: NEJM 14-month follow-up
  3. Primary: ClinicalTrials.gov study record
  4. Independent: Independent research commentary record

Correction and revision history

  1. 2025-08-04 — First-in-human result published online in the New England Journal of Medicine.
  2. 2026-07-10 — Peer-reviewed NEJM follow-up reported beta-cell function and no detected graft-directed immune response through 14 months; status and evidence tier remain unchanged because the evidence still concerns one low-dose participant.

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