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New hope for diabetics with kidney transplants: islet cells may end insulin shots

NCT ID NCT01123187

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether transplanting insulin-making islet cells could help people with type 1 diabetes who already had a kidney transplant. Fourteen participants received up to three infusions of donor islet cells along with steroid-free immunosuppression. The goal was to see if they could stop taking insulin and keep their blood sugar under control one year later.

What this could mean

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

Active substance
islet cell transplant
What this could lead to
If successful, this approach could help some people with type 1 diabetes who have had a kidney transplant achieve insulin independence and better blood sugar control.
What could go wrong
This is a small, early-phase study with only 14 participants, so results may not apply to everyone. The procedure and required immunosuppression carry risks like infection and bleeding.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

14 people

The number who actually took part.

Start date

Mar 2003

Finished

Apr 2016

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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.

Inclusion Criteria: * Type 1 diabetes mellitus. Documentation of negative basal and stimulated C-peptide and diagnosis of diabetes for at least 5 years. * Recipient of renal transplant with good function (creatinine clearance \>/=60 ml/min) * Stable immunosuppression consisting of any combination of sirolimus, tacrolimus for at least 6 months, without major complications * Ability to give informed consent. * Age greater than or equal to 18 years or less than or equal to 65 years * No evidence of liver disease (liver enzymes \< twice the upper limit of normal) Exclusion Criteria: * Age below 18 years and above 65 years * Significant cardiovascular disease, including non-correctable coronary artery disease and/or recent myocardial infarction(within last 12 months); extensive peripheral vascular disease not correctable by surgery, unstable angina * Untreated proliferative retinopathy. * Recent Cerebrovascular accident (within last 12 months) * Recent unresolved acute infection, or chronic infection, including tuberculosis, HIV, HBV, HCV, CMV or positive skin test for TB * Any history of malignancy, except squamous or basal skin cancer or in situ cancer of the cervix. * History of non-compliance, or inability to demonstrate capacity to comply with strict blood glycemic control and insulin pump therapy. * Psychiatric illness that is untreated, or likely to interfere significantly with transplantation despite treatment. * Pregnant women, women intending future pregnancy, women of reproductive potential who are unable or unwilling to follow effective contraceptive measures for the duration of immunosuppressive therapy * Fasting C-peptide \> 0.2 ng/ml * Creatinine \> 25mg/l * Alkaline phosphatase, total bilirubin, Alanine Aminotransferase (ALT)or Aspartate Aminotransferase (AST) \> twice the upper limit of normal * Significant liver disease (elevation of liver enzymes \> twice the upper limit of normal for each of ALT and AST, liver masses including portal vein thrombosis, evidence of portal hypertension, or significant, untreated gallbladder disease (i.e., gallstones).

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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.

Contacts and locations

Locations

  • University Hospital of Lille

    Lille, Nord, 59000, France

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