Sana SC451: hypoimmune stem-cell-derived islets without immunosuppression
What this study tests
SC451 is a planned stem-cell-derived hypoimmune islet therapy, intended to restore insulin production without immunosuppression. Sana’s August 2026 update and September investor presentation retain a 2026 IND and Phase 1/2 start goal. This is a development-plan record, not a confirmed trial opening. Published human proof of concept comes from a different product, UP421 donor islets, in one recipient.
Editorial review: .
Most recent recorded citation date: 2026-08-10. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- SC451 trial eligibility has not been established from a registered protocol in this review. Eligibility from the related UP421 donor-islet trial must not be applied to SC451.Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No SC451 clinical results were identified. The related UP421 report describes gene-edited donor islets transplanted into one man’s forearm muscle without immunosuppressive drugs. At 12 weeks, C-peptide was stable and glucose responsive. No immune response was detected against the fully HIP-modified cells, while partially edited double-knockout cells elicited an innate immune response. Four adverse events occurred, none serious or attributed to the islet-cell product; lower-arm paresthesia was possibly procedure-related. A July 2026 NEJM follow-up letter is indexed, but its full text was not accessible in this review. Sana reports graft survival and insulin production through 14 months; that manufacturer summary is not a directly checked outcome table here. This low-dose single-recipient experiment does not establish insulin independence or SC451 efficacy.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions are not specified here. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability. This record cites company or conference reports. Those sources may describe interim findings; their source type is shown in the source list.
Primary endpoints
- SC451: a registered trial protocol and its endpoints were not identified in this review.
- Related UP421 study: number of treatment-related adverse events assessed using CTCAE v5.0 over 12 months.
The full picture
A planned product and a different human proof of concept
SC451 is Sana’s O-negative, hypoimmune-modified, induced-pluripotent-stem-cell-derived islet product candidate. Its intended goal is a one-time treatment that restores glucose control without injected insulin or immunosuppression. Those are development goals, not demonstrated SC451 outcomes.5
Sana’s August 2026 update said it was preparing toxicology, manufacturing transfer and clinical readiness, with an IND and Phase 1/2 start possible in 2026. Its September SEC-filed presentation retained the 2026 goal. An exact-term ClinicalTrials.gov search for SC451 on 17 September returned no records; this limited search does not establish absence from every registry. Trial eligibility, sites and endpoints remain unconfirmed.56
What UP421 showed
UP421 uses gene-edited primary donor islets, whereas SC451 is stem-cell-derived. The original UP421 paper reports transplantation into one man’s forearm without immunosuppressive drugs. Over 12 weeks, insulin secretion measured by C-peptide was stable and glucose responsive. No immune response was detected against the fully HIP-modified cells; partially edited double-knockout cells elicited an innate immune response. Four adverse events occurred, none serious or attributed to the islet-cell product; lower-arm paresthesia was possibly procedure-related.2
The related registry planned two participants and used treatment-related adverse events over 12 months as its primary outcome. That planned enrollment must not replace the single-recipient denominator of the published report. Its old recruiting label is not proof of current availability.1
A NEJM follow-up letter was published in July 2026. Its full text was not accessible in this review. Sana’s accompanying announcement reports cell survival and insulin production through 14 months in the same recipient, but the detailed follow-up outcomes have not been independently checked against the letter here.34
This was a deliberately low-dose proof-of-concept study, not a demonstration of insulin independence. Absence of immunosuppressive drugs does not mean the person required no medicines or insulin. Moving to a stem-cell-derived product, an effective dose and larger cohorts remains necessary before drawing conclusions about SC451’s benefit and safety.54
Sources
- [1]NCT06239636 — First-in-human Safety Study of Hypoimmune Pancreatic Islet Transplantation in Adult Subjects With Type 1 Diabetes (UP421) · Trial registry — Related UP421 study, not SC451. The live ClinicalTrials.gov API retains an estimated enrollment of 2 and a recruiting label last updated 11 December 2024; passed estimated completion dates do not establish completion. Exact-term SC451 search on 17 September 2026 returned no records, which does not prove absence from every registry.
ClinicalTrials.gov. NCT06239636: UP421 first-in-human safety study.
- [2]Survival of Transplanted Allogeneic Beta Cells with No Immunosuppression · Peer-reviewed study · 2025-09-04 — The original UP421 report — 12-week results in one participant.
Carlsson P-O, et al. Survival of Transplanted Allogeneic Beta Cells with No Immunosuppression. New England Journal of Medicine (2025).
- [3]Long-Term Survival of Hypoimmune Allogeneic Islets without Immunosuppression · Peer-reviewed study · 2026-07-10 — Indexed follow-up letter. Full text was not accessible in the 17 September 2026 primary review; detailed 14-month findings remain attributed to the manufacturer summary.
Carlsson P-O, et al. Long-Term Survival of Hypoimmune Allogeneic Islets without Immunosuppression. New England Journal of Medicine (2026), letter.
- [4]Sana Biotechnology Announces Follow-On Publication in the New England Journal of Medicine Highlighting Long-Term Data and Durability of Hypoimmune-Modified Islet Cell Transplantation Without Immunosuppression in Type 1 Diabetes · Manufacturer · 2026-07-13 — Sana's announcement of the NEJM letter. Also the source for the SC451 IND/Phase 1/2 guidance ("as early as this year") and for the caveat that the study was not designed to reduce insulin use.
Sana Biotechnology. Announcement of the NEJM follow-up, 13 July 2026.
- [5]Sana Biotechnology Reports Second Quarter 2026 Financial Results and Business Updates · Manufacturer · 2026-08-10
Sana Biotechnology. Second-quarter 2026 results and business update, 10 August 2026.
- [6]Sana investor presentation filed with the SEC: SC451 2026 development goal · Manufacturer — Company development goal; does not establish IND clearance, enrollment or efficacy.
Sana Biotechnology. Investor presentation filed with the SEC, 2026: SC451 development goals.