AzTrials
AzTrials

Diabetes Mellitus, Type 1Phase 2NCT01241864

Islet Transplantation in Type 1 Diabetic Kidney Allograft

A Phase 2 study testing Allogenic islet cells (human, U. Chicago) and Intraportal infusion of islet cells in people with Diabetes Mellitus, Type 1, run by University of Chicago at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to learn about the safety of islet transplantation when performed after kidney transplantation, which may provide more normal control of blood sugar without the need for insulin shots. Islets are special clusters of cells within the pancreas that produce insulin. Read more about this study

Who is it for?
Ages 18 to 68 years
Conditions the study is for
Diabetes Mellitus, Type 1
What is being tested?
Allogenic islet cells (human, U. Chicago) and Intraportal infusion of islet cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited States
Study dates
Dec 2010to Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 68 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lindsay Basto, RN, BSN contact

773-702-2504

Lindsay.Basto@uchospitals.edu

Piotr Witkowski, MD, PhD contact

(773) 702-2447

pwitkowski@surgery.bsd.uchicago.edu

United States1 site, 1 recruiting

  • The University of Chicago

    Chicago, Illinois, 60637

    Lindsay Basto, RN, BSN, 773-702-2504, Lindsay.Basto@uchospitals.edu

    Piotr Witkowski, MD, PhD

    Recruiting

Other trials in United States

About this study

The purpose of this study is to learn about the safety of islet transplantation when performed after kidney transplantation, which may provide more normal control of blood sugar without the need for insulin shots. Islets are special clusters of cells within the pancreas that produce insulin. These cells will be obtained from cadaver (non-living) donors and given to subjects by vein.

Being tested
Allogenic islet cells (human, U. Chicago), Intraportal infusion of islet cells
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Allogenic islet cells (human, U. Chicago)Biological

    Human allogenic islet cells. Immunosuppression varies but may include prograf, cellcept, sirolimus, prednisone. Dosage will vary per patient based on weight. Patients will receive immunosuppression medications while islet cells are functioning.

  • Intraportal infusion of islet cellsProcedure or surgery

    Intraportal infusion of islet cell through the portal vein in the liver.

Study groups in NCT01241864
Study groupRoleWhat they receive
Allogenic islet cells (human, U. Chicago)ExperimentalNot described
Receives: Biological: Allogenic islet cells (human, U. Chicago); Procedure: Intraportal infusion of islet cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbAlc <6.5% and an absence of severe hypoglycemic events

    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.

    Measured: 1 year after transplantation

Secondary outcomes (1)

  1. HbAlc < 6.5% and an absence of severe hypoglycemic events measured after last transplant

    The primary endpoint measured at one year after the last islet transplant. That is the proportion of subjects with both an HbAlc < 6.5% and an absence of severe hypoglycemic events at 1 year after the last islet transplant or a reduction in HbAlc of 1 point and an absence of severe hypoglycemia at 1 year after the last islet transplant.

    Measured: 365 ± 14 days after the last islet transplant

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01241864
Sponsor's protocol ID
10-479-A
Other IDs
BB-IND 11228
Status last verified
Dec 2025
First submitted
12 Nov 2010
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Pathak P, Thampy R, Schat R, Bellin M, Beilman G, Hosseini N, Spilseth B. Transplantation for type 1 diabetes: radiologist's primer on islet, pancreas and pancreas-kidney transplantation imaging. Abdom Radiol (NY). 2024 Oct;49(10):3637-3665. doi: 10.1007/s00261-024-04368-8. Epub 2024 May 28.

    PubMed 38806704

  • Gariani K, Peloso A, Galani V, Haidar F, Wassmer CH, Kumar R, Lacin EH, Olivier V, Prada P, Compagnon P, Berishvili E, Berney T. Effect of islet alone or islets after kidney transplantation on quality of life in type 1 diabetes: A systematic review. Transplant Rev (Orlando). 2024 Dec;38(4):100870. doi: 10.1016/j.trre.2024.100870. Epub 2024 Jun 21.

    PubMed 38917621

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Allogenic islet cells (human, U. Chicago) and Intraportal infusion of islet cells in people with Diabetes Mellitus, Type 1, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lindsay Basto, RN, BSN (773-702-2504, Lindsay.Basto@uchospitals.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbAlc <6.5% and an absence of severe hypoglycemic events (time frame: 1 year after transplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01241864, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in