Could donor islet cells free diabetics from insulin after kidney transplant?
NCT ID NCT01241864
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 2 trial tests whether transplanting insulin-producing islet cells from deceased donors can help people with type 1 diabetes who have already received a kidney transplant. The goal is to achieve safe blood sugar levels without insulin shots. Ten participants will receive the cells via a vein in the liver and must take immunosuppressant drugs as long as the cells work.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Allogenic islet cells (donor pancreas cells) plus immunosuppressant drugs
- What this could lead to
- If successful, this could help people with type 1 diabetes who have had a kidney transplant achieve near-normal blood sugar without insulin shots, reducing complications.
- What could go wrong
- This is a very small early-phase trial (10 people) and requires lifelong immunosuppression, which carries risks like infection and organ damage. It may not work for everyone.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2010
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 68 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.
Inclusion Criteria: * Male and female subjects age 18 to 68 years. * Subjects who are able to provide written informed consent and to comply with the procedures of the study protocol. * Clinical history compatible with T1D with disease onset \< 40 years of age and insulin-dependence for \> 5 years at the time of enrollment, and a sum of subject age and insulin dependent diabetes duration of \> 28. * Absent stimulated c-peptide (\< 0.3 ng/mL) in response to a MMTT \[Boost® 6 mL/kg body weight (BW) to a maximum of 360 mL; another product with equivalent caloric and nutrient content may be substituted for Boost®\] measured at 60 and 90 min after start of consumption. * Subjects who are \> or at 3 months post-renal transplant who are taking appropriate calcineurin inhibitor (CNI) based maintenance immunosuppression (\[tacrolimus alone or in conjunction with sirolimus, mycophenolate mofetil, myfortic, or azathioprine; or cyclosporine in conjunction with sirolimus, mycophenolate mofetil, or myfortic\] ± Prednisone \< 10 mg/day)or subject will receive islets transplant within 72hours after kidney transplantation (islets and kidney are from the same donor) * Stable renal function as defined by a creatinine of no more than one third greater than the average creatinine determination performed in the 3 previous months prior to islet transplantation, until rejection, obstruction or infection is ruled out. Exclusion Criteria: * Weight more than 90 kg or body mass index (BMI) \> 30 kg/m2. * Insulin requirement of \>1.0 IU/kg/day or \<15 U/day. * Other (non-kidney) organ transplants except prior failed pancreatic graft where the graft failed within the first two weeks due to thrombosis, followed by pancreatectomy; with the pancreas transplant occurring more than 6 months prior to enrollment. * Untreated or unstable proliferative diabetic retinopathy. * Blood Pressure: SBP \> 160 mmHg or DBP \>100 mmHg despite treatment with antihypertensive agents. * Calculated GFR \< 40 mL/min/1.73 m2 using the subject's measured serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation \[1\]. Strict vegetarians (vegans) will be excluded only if their estimated GFR is \< 35 mL/min/1.73 m2 * Proteinuria (albumin/ creatinine ratio or ACr \> 300mg/g) of new onset since kidney transplantation. * Either Class I or Class II panel-reactive anti-HLA antibodies \> 50%. Subjects with either Class I or Class II panel reactive anti-HLA antibodies \>50% will be excluded if any of the following are detected: Positive cross-match, Islet donor-directed anti-HLA antibodies detected by Luminex Single Antigen/specificity bead assay including weakly reactive antibodies that would not be detected by a flow cross-match, or Antibodies to the renal donor (i.e. presumed de novo). * For female subjects: Positive pregnancy test, presently breast-feeding, desires to be pregnant at any time point in the future, which includes during or after the completion of the study even if study participation is ended early, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. For male subjects: intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception. Oral contraceptives, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable. * Presence or history of active infection including hepatitis B, hepatitis C, HIV, or tuberculosis (TB). Subjects with laboratory evidence of active infection are excluded even in the absence of clinical evidence of active infection.
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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
1 site. 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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The University of Chicago
RECRUITINGChicago, Illinois, 60637, United States
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