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Could this Stem-Cell infusion end insulin shots for diabetics with kidney transplants?

NCT ID NCT06832410

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 study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 study tests VX-880, a stem-cell therapy infused into the liver, in 10 people with type 1 diabetes who have already received a kidney transplant. The main goal is to see if participants can stop using insulin entirely. The therapy is given alongside standard transplant drugs to prevent rejection.

What this could mean

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

Active substance
VX-880 (Zimislecel), a stem-cell derived therapy infused into the liver's portal vein
What this could lead to
If successful, this could allow people with type 1 diabetes and a kidney transplant to stop taking insulin, while continuing their transplant-related immunosuppression.
What could go wrong
This is a very small early-phase 3 trial (only 10 participants). The therapy requires lifelong immunosuppression for the kidney transplant, and it may not achieve lasting insulin independence or could cause side effects.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2025

Expected to finish

Sep 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 of insulin dependence * Taking a stable immunosuppression regimen of tacrolimus and mycophenolate mofetil, mycophenolate sodium, or sirolimus for at least 4 weeks * Consistent use of continuous glucose monitor (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 (other than kidney transplant), or cell therapy, except prior pancreatic graft that failed within the first 4 weeks * Participants had \>1 kidney transplant procedure Other protocol defined Inclusion/Exclusion criteria may apply.

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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.

Kidney transplant Type 1 diabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    7 sites in 3 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology

    RECRUITING

    Riyadh, Saudi Arabia

  • King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology

    RECRUITING

    Riyadh, Saudi Arabia

  • Montefiore Clinical and Translational Research Center - Endocrinology

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • Perelman Center for Advanced Medicine - Endocrinology

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Toronto General Hospital - Endocrinology

    RECRUITING

    Toronto, Canada

  • UW University Hospital - Endocrinology

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • Vancouver General Hospital - Gordon and Leslie Diamond Health Care Centre

    RECRUITING

    Vancouver, Canada

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