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Could stem cell islets end daily insulin shots?

NCT ID NCT05791201

Disease control Sponsor: Vertex Pharmaceuticals Incorporated Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 11, 2026 · Updated 3 times

Summary

This early-phase trial tests VX-264, a therapy made from stem cells that produce insulin, in 7 people with long-standing type 1 diabetes. The goal is to see if it is safe and can help control blood sugar. If successful, it may reduce or replace the need for insulin injections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Stem cell-derived insulin-producing cells (VX-264)
What this could lead to
If it works, this could free people with type 1 diabetes from daily insulin injections by providing a renewable source of insulin-making cells.
What could go wrong
This is a very early, small trial (only 7 participants) focused on safety. The cells may not survive long-term, and participants may still need immunosuppressant drugs, which carry risks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

7 people

The number who actually took part.

Started

May 2023

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: Clinical history of T1D with greater than or equal to (\>=) 5 years duration Participant is on a stable diabetic treatment Consistent use of continuous glucose monitoring (CGM) for at least 4 weeks before Screening and willingness to use CGM for the duration of the study Key Exclusion Criteria: Prior islet cell transplant, organ transplant, or cell therapy

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Conditions

The condition(s) this trial relates to.

type 1 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 1 diabetes

Contacts and locations

Locations

  • Churchill Hospital

    Headington, United Kingdom

  • Dresden Center for Islet Transplantation

    Dresden, Germany

  • Hopiteaux Universitaires de Geneve

    Geneva, Switzerland

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • IRCCS Ospedale San Raffaele

    Milan, Italy

  • Leiden University

    Leiden, Netherlands

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Montreal Clinical Research Institute

    Montreal, Canada

  • Royal Victoria Infirmary

    Newcastle upon Tyne, United Kingdom

  • Toronto General Hospital (TGH)

    Toronto, Canada

  • UHealth Diabetes Research Institute

    Miami, Florida, 33136, United States

  • University of Alberta, Edmonton

    Edmonton, Canada

  • University of Chicago

    Chicago, Illinois, 60637, United States

  • University of Pittsburgh Medical Center Montefiore

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Wisconsin

    Madison, Wisconsin, 53792, United States

  • Vancouver General Hospital

    Vancouver, Canada

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