Could this cell therapy free type 1 diabetes patients from insulin?
NCT ID NCT04786262
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 4 times
Summary
This study tests a treatment called VX-880 for people with type 1 diabetes who have dangerous low blood sugar episodes. The therapy uses donor cells that can produce insulin, aiming to let participants stop taking insulin shots and avoid severe hypoglycemia. About 52 adults with long-standing diabetes will receive the infusion and be monitored for safety and effectiveness.
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 57 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2021
- Expected to finish
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Dec 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 \>=5 years of duration of insulin dependence * At least two episodes of documented severe hypoglycemia in the 12 months prior to enrollment * Stable diabetic treatment * Consistent use of continuous glucose monitor (CGM) for at least 3 months 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 Other protocol-defined Inclusion/Exclusion criteria may apply
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
26 sites in 9 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Baylor Scott and White Research Institute
RECRUITINGDallas, Texas, 75246, United States
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CHU Lille
RECRUITINGLille, France
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Cardiovascular, Metabolic Medicine and Sciences, King's College London
RECRUITINGLondon, United Kingdom
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Centre de recherche en Biomédecine de Strasbourg
RECRUITINGStrasbourg, France
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Churchill Hospital
RECRUITINGHeadington, Oxford, United Kingdom
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City of Hope
RECRUITINGDuarte, California, 91010, United States
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Dresden Center for Islet Transplantation
RECRUITINGDresden, Germany
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Hopiteaux Universitaires de Geneve
COMPLETEDGeneva, Switzerland
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Hospital of the University of Pennsylvania
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
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IRCCS Ospedale San Raffaele
RECRUITINGMilan, Italy
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Johns Hopkins University
COMPLETEDBaltimore, Maryland, 21287, United States
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King Abdullah International Medical Research Center (KAIMRC) - Riyadh - Endocrinology
RECRUITINGRiyadh, Saudi Arabia
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King Faisal Specialist Hospital & Research Centre - Riyadh - Endocrinology
RECRUITINGRiyadh, Saudi Arabia
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Leiden University
RECRUITINGLeiden, Netherlands
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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McGill University Health Centre
RECRUITINGMontreal, Canada
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Northwestern Organ Transplant Center
COMPLETEDChicago, Illinois, 60611, United States
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Oslo University Hospital
RECRUITINGOslo, Norway
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Royal Infirmary of Edinburgh
RECRUITINGEdinburgh, United Kingdom
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The Newcastle upon Tyne Hospitals NHS Foundation Trust
RECRUITINGNewcastle upon Tyne, United Kingdom
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Toronto General Hospital (TGH)
RECRUITINGToronto, Canada
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UHealth Diabetes Research Institute
RECRUITINGMiami, Florida, 33136, United States
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University of Alberta, Edmonton
RECRUITINGEdmonton, Canada
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University of California San Francisco
RECRUITINGSan Francisco, California, 94143, United States
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University of Chicago
RECRUITINGChicago, Illinois, 60637, United States
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University of Pittsburgh Medical Center Montefiore
RECRUITINGPittsburgh, Pennsylvania, 15213, United States
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University of Wisconsin
RECRUITINGMadison, Wisconsin, 53792, United States
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VCU Medical Center, Richmond
RECRUITINGRichmond, Virginia, 23298, United States
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Vancouver General Hospital
RECRUITINGVancouver, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a glucose app that predicts lows calm diabetes fears?
- Could type 1 diabetes hide liver problems in children?
- Can a Weight-Loss drug slow stomach emptying in type 1 diabetes?
- Can pressurized oxygen tame blood sugar spikes?
- Could a virtual life-coach program help young adults tame type 1 diabetes?
- Can Real-World data improve diabetes care in pregnancy?