Islet Transplantation for "Brittle" Type 1 Diabetes
This study is looking into the safety of transplanting islet cells into people with "brittle" Type 1 diabetes. Islet cells are special cells from the pancreas that make insulin. These cells, from non-living donors, will be given to you through a vein in your liver. The goal is to help your body control blood sugar more normally, possibly reducing the need for insulin shots. You might also receive medications like remicade or prograf to help your body accept the new cells. To join, you need to be between 18 and 70 years old, have had Type 1 diabetes for at least 5 years, and meet other specific health criteria. The study will consider it a success if your HbA1c (a measure of blood sugar control) is below 7.0% and you don't have severe low blood sugar events after one year.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 20 participants.
- What's involved
- You will receive human allogenic islet cells through an infusion into your liver. You will also take immunosuppression medications while the islet cells are working.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure your blood sugar control and severe low blood sugar events at 1 year after the intervention.
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NCT01630850
Islet Transplantation in Patients With "Brittle" Type I Diabetes
Recruiting
NAAges 18–70InterventionalTreatmentUniversity of ChicagoInvestigator-initiated
~20 participants
Updated 2025-12-09 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 <7.0% and an absence of severe hypoglycemic events
Measured over 1 year
Conditions
Where it's being run
1 sites across 1 statesIllinois1
Study leadership
- Piotr Witkowski, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Chicago
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Male and female patients 18 to 70 years of age.
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 onset of disease at \< 40 years of age, insulin-dependence for ≥ 5 years at the time of enrollment, and a sum of patient age and insulin dependent diabetes duration of ≥ 28 and absent stimulated c-peptide (\<0.3ng/mL) in response to a mixed meal tolerance test (MMTT; Boost® 6 mL/kg body weight 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 the start of consumption and at least one episode of severe hypoglycemia in the 12 months prior to study enrollment; OR a clinical history of "problematic hypoglycemia" defined as defined as two or more episodes per year of severe hypoglycemia or as one episode associated with impaired awareness of hypoglycemia, extreme glycemic lability, or major fear and maladaptive behavior according to recent clinical recommendations.
Involvement in intensive diabetes management defined as self monitoring of glucose values no less than a mean of three times each day averaged over each week and by the administration of three or more insulin injections each day or insulin pump therapy. Such management must be under the direction of an endocrinologist, diabetologist, or diabetes specialist with at least 3 clinical evaluations during the 12 months prior to study enrollment.
Reduced awareness of hypoglycemia as defined by a Clarke score of 4 or more OR a HYPO score greater than or equal to the 90th percentile (1047) during the screening period and within the last 6 months; OR marked glycemic lability characterized by wide swings in blood glucose despite optimal diabetes therapy and defined by an LI score greater than or equal to the 90th percentile (433 mmol/L2/h -wk1) during the screening period and within the last 6 months prior to randomization; OR a composite of a Clarke score of 4 or more and a HYPO score greater than or equal to the 75th percentile (423) and a LI greater than or equal to the 75th percentile (329) during the screening period and within the last 6 months.
Exclusion
Body mass index (BMI) \>30 kg/m2 or patient weight \<50kg.
Insulin requirement \>1.0 IU/kg/day or \<15 U/day.
Untreated proliferative diabetic retinopathy.
Blood Pressure: SBP \>160 mmHg or DBP \>100 mmHg.
Measured glomerular filtration rate \<80 mL/min/1.73m2 (using iohexol or calculated using the subject's measured serum creatinine and the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI equation) or based on 24-hrs urine collection. Strict vegetarians (vegans) with a calculated GFR \<70 mL/min/1.73m2 are excluded. The absolute (raw) GFR value will be used for subjects with body surface areas \>1.73 m2.
Presence or history of macroalbuminuria (\>300 mg/g creatinine).
Presence or history of panel-reactive anti-HLA antibodies above 30% or history/presence of donor specific anti-HLA antibodies in order to avoid unacceptable antigen(s) (Campbell PM 2007).
For female subjects: Positive pregnancy test, presently breast-feeding, wishes 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.
Known active alcohol or substance abuse.
Severe co-existing cardiac disease
Known hypercoagulative state.
Symptomatic cholecystolithiasis.
Acute or chronic pancreatitis.
What this trial measures
- HbAlc <7.0% and an absence of severe hypoglycemic events1 year
The proportion of subjects with an HbAlc \<7.0% at Day 365 AND free of severe hypoglycemic events from Day 28 to Day 365 inclusive following the first islet transplant.