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Islet Transplantation for Type 1 Diabetes After Kidney Transplant

This study is looking at the safety of transplanting allogenic islet cells (special cells from a donor pancreas that make insulin) into people with Type 1 diabetes who have already had a kidney transplant. The goal is to help you control your blood sugar better and potentially reduce or eliminate the need for insulin shots. The islet cells will be given through a procedure called intraportal infusion, where they are placed into a vein in your liver. You would also receive immunosuppression medications like prograf, cellcept, sirolimus, and prednisone to prevent your body from rejecting the new cells. The study hopes to see if participants can achieve an HbA1c (a measure of blood sugar control) below 6.5% and have no severe low blood sugar events one year after the transplant. This study is for people aged 18 to 68 with Type 1 diabetes and is currently unclear if it's open for new participants.

Study design
This is an interventional study planning to enroll 10 participants. It is not specified if it is randomized or blinded.
What's involved
You would receive allogenic islet cells through an intraportal infusion procedure and take immunosuppression medications. The specific dosage of medication will vary based on your weight.
Compensation
Not stated in the trial record.
Follow-up
Your blood sugar control will be measured at one year after the transplantation to see if the treatment was successful.

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NCT01241864

Islet Transplantation in Type 1 Diabetic Kidney Allograft

Recruiting
PHASE2Ages 18–68InterventionalTreatment
University of Chicago
~10 participants
Updated 2025-12-08 on ClinicalTrials.gov
What's tested:Allogenic islet cells (human, U. Chicago)Intraportal infusion of islet cells

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
HbAlc <6.5% and an absence of severe hypoglycemic events
Measured over 1 year after transplantation

Conditions

Diabetes Mellitus, Type 1

Explore related trials

Type 1 Diabetes MellitusC Peptide

Where it's being run

1 sites across 1 states
Illinois1

Who to contact

Lindsay Basto, RN, BSN
[email protected]
773-702-2504
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • HbAlc <6.5% and an absence of severe hypoglycemic events1 year after transplantation

    The proportion of subjects with both an HbAlc \<6.5% and an absence of severe hypoglycemic events at 1 year after the first islet transplant or a reduction in HbAlc of at least 1 point and an absence of severe hypoglycemic events at 1 year after the first islet transplant.