Treatment goal
Insulin independence via replacement of lost beta-cell function.
Type of approach
Stem-cell-derived, manufactured pancreatic islet cells (allogeneic, not from the patient's own cells).
Current evidence
Human evidence of benefit — Phase 1/2, published in the New England Journal of Medicine.
Trial phase & enrollment
Phase 1/2. 12 participants at full dose reported in this readout.
Who may qualify
Adults with Type 1 diabetes and a history of severe hypoglycemia / impaired hypoglycemia awareness.Exact criteria pending verification against the current ClinicalTrials.gov listing — do not assume specific age or C-peptide cutoffs from this page.
Location & travel
Multi-site U.S. trial.Confirm currently active sites via ClinicalTrials.gov before relying on this for enrollment.
What participants undergo
Infusion of donor-derived islet cells, plus a standard immunosuppression regimen to prevent rejection; ongoing monitoring and glucose tracking.
Possible benefits
Reduced or eliminated need for external insulin; improved glycemic stability.
Known & unknown risks
Standard risks of chronic immunosuppression (infection risk, kidney effects, others per regimen). Long-term durability beyond the one-year readout is not yet established.
Immunosuppression requirement
Yes — standard regimen, ongoing. This is the specific reason the program is a functional cure, not yet a durable cure, under our three-part standard.
Results so far
10 of 12 full-dose participants (83%) insulin-independent at day 365.
Definition of success used
Insulin independence at one year — distinct from "reduced insulin use," a lower bar some coverage of this trial has blurred.
Duration / follow-up
One-year data reported; longer follow-up ongoing, not yet published.
Cost & compensation
Not disclosed in the sources reviewed.Standing caveat: do not assume any specific cost or compensation figure until a program discloses one directly.
Sponsor
Vertex Pharmaceuticals. No third-party conflict identified in the sources reviewed.
How to find a site
Search ClinicalTrials.gov for the current active zimislecel listing.We have not independently re-verified a specific listing URL as still active — search rather than trust a static link here.