Diabetes Mellitus, Type 1Phase 1/2NCT00160732
Allogenic Islet Cell Transplantation
A Phase 1/2 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.
Trial summary
The purpose of this study is to determine the safety of transplanting human islet cells for controlling hyperglycemia in brittle and/or complex patients with type 1 diabetes. In addition, initial observations will be made with regards to the effectiveness of reversing hypoglycemia with this treatment. Read more about this study
- Who is it for?
- Ages 18 to 58 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
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2003to Oct 2030
- Phase
- Phase 1/2
- 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 58 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must have type I diabetes mellitus, documented by undetectable C-peptide. Patients must have been diabetic for at least five years, and be aged 18 - 58 years.
- Patients must be on an intensive regimen of glucose monitoring and exogenous insulin injection (defined as greater than or equal to three checks and injections per day). This regimen must be prescribed and supervised by the patient's diabetologist.
- Despite intensive therapy, patients must have at least one of the following:
- Brittle diabetes (metabolic instability), as defined by elevated mean amplitude of glycemic excursion;
- Hypoglycemic unawareness, with at least one episode in the past two years in which hypoglycemia required the assistance of another person (e.g., family member, emergency medical technician [EMT], etc.), and was associated with a fingerstick blood glucose (FSBG) of < 50 mg/dl and prompt recovery after administration of oral glucose, intravenous glucose, or glucagon;
- Progressive complications of diabetes (nephropathy manifested by proteinuria, retinopathy documented by an ophthalmologist after dilated eye exam, or neuropathy as determined by a neurologist).
- Patients must be able to give informed consent.
Who cannot join
- Failure to meet inclusion criteria
- Panel of Reactive Antibody (PRA) > 10%
- Creatinine clearance < 80 mL/min
- Prior organ transplant
- Portal hypertension: this refers to portal hypertension diagnosed previously by any means, or, by the investigators' evaluation, symptoms and/or signs of liver dysfunction with or without portal hypertension including, but not limited to, jaundice, ascites, encephalopathy, spider angiomata, coagulopathy, or peri-umbilical venous engorgement. Elevated portal pressures, as measured during intended islet infusion, may also result in discontinuation of infusion.
- Abnormal liver function tests (> 2 times the upper limit of normal as defined by the University of Chicago Clinical Laboratory)
Show all 21Show fewer
- History of malignancy. Any history of malignancy in a patient who has had an "adequate" period of no evidence of neoplastic disease should not rule out individuals from enrolling in this study. Rather, pre-enrollment screening for malignancy will follow current established guidelines as for solid-organ transplant. These current guidelines appear in Kasiske, B.L., et al. "The Evaluation of Renal Transplant Candidates: Clinical Practice Guidelines," American Journal of Transplantation 1 (Supplement 2): 12-22, 2001.
- Active peptic ulcer disease
- Pregnancy, or inability to comply with contraceptive regimen
- Severe unremitting gastroparesis or diarrhea
- Active infection
- Serologic positivity for HIV and/or hepatitis
- Chest radiographic abnormality consistent with neoplastic or infectious disease
- Major ongoing psychiatric illness and/or substance abuse
- Noncompliance with current medical regimen
- Obesity (body mass index [BMI] > 28)
- Any other medical condition precluding safe transplantation and immunosuppression
- Ejection fraction < 30%
- Myocardial infarction (MI) within the past 6 months
- Known allergies or hypersensitivity to immunosuppressive agents used in this protocol
- Inability to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago Hospitals
Chicago, Illinois, 60637
About this study
Official title: Allogenic Islet Cells (Human, U. of Chicago) Administered Via Intraportal Infusion; and Immunosuppressive Therapy
The purpose of this study is to determine the safety of transplanting human islet cells for controlling hyperglycemia in brittle and/or complex patients with type 1 diabetes. In addition, initial observations will be made with regards to the effectiveness of reversing hypoglycemia with this treatment. The "Edmonton Protocol" of using specific anti-rejection drugs without steroids is also being evaluated.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Allogenic islet cells (human, U. Chicago), Intraportal infusion of islet cells
- Keywords
- Islet Cell Transplant, Human islet cell infusion, Juvenile-onset diabetes
- 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)Drug
Human allogenic islet cells. Immunosuppression varies but may include prograf, celcept, 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 group | Role | What they receive |
|---|---|---|
| Transplant | Experimental | Not described Receives: Drug: 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.
decrease in insulin requirement - Subjects able to maintain fasting blood glucose concentrations below 126 mg/dL and 2-hour post prandial levels below 180 mg/dL will be considered to be insulin independent.
Measured: Monthly
decrease in incidence of hypoglycemic events
Measured: Monthly
Secondary outcomes (1)
absence of complications from the procedure and side effects of the medication
Measured: Monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startOct 2003
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piotr Witkowski, MD, Ph.D., Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160732
- Sponsor's protocol ID
- 12176A
- Other IDs
- BB-IND 11228
- Status last verified
- May 2025
- First submitted
- 8 Sep 2005
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Shapiro AM, Lakey JR, Ryan EA, Korbutt GS, Toth E, Warnock GL, Kneteman NM, Rajotte RV. Islet transplantation in seven patients with type 1 diabetes mellitus using a glucocorticoid-free immunosuppressive regimen. N Engl J Med. 2000 Jul 27;343(4):230-8. doi: 10.1056/NEJM200007273430401.
PubMed 10911004
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogenic Islet Cells (Human, U. of Chicago) Administered Via Intraportal Infusion; and Immunosuppressive Therapy
- ClinicalTrials.gov ID
- NCT00160732
- Acronym / sponsor ID
- 12176A
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Islet Cell Transplant, Human islet cell infusion, Juvenile-onset diabetes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Oct 2003 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the safety of transplanting human islet cells for controlling hyperglycemia in brittle and/or complex patients with type 1 diabetes. In addition, initial observations will be made with regards to the effectiveness of reversing hypoglycemia with this treatment. The "Edmonton Protocol" of using specific anti-rejection drugs without steroids is also being evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transplant | Experimental | Drug: Allogenic islet cells (human, U. Chicago), Procedure: Intraportal infusion of islet cells |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients must have type I diabetes mellitus, documented by undetectable C-peptide. Patients must have been diabetic for at least five years, and be aged 18 - 58 years.
- Patients must be on an intensive regimen of glucose monitoring and exogenous insulin injection (defined as greater than or equal to three checks and injections per day). This regimen must be prescribed and supervised by the patient's diabetologist.
- Despite intensive therapy, patients must have at least one of the following:
- Patients must be able to give informed consent.
Key exclusion criteria (21 listed)
- Failure to meet inclusion criteria
- Panel of Reactive Antibody (PRA) > 10%
- Creatinine clearance < 80 mL/min
- Prior organ transplant
- Portal hypertension: this refers to portal hypertension diagnosed previously by any means, or, by the investigators' evaluation, symptoms and/or signs of liver dysfunction with or without portal hypertension including, but not limited to, jaundice, ascites, encephalopathy, spider angiomata, coagulopathy, or peri-umbilical venous engorgement. Elevated portal pressures, as measured during intended islet infusion, may also result in discontinuation of infusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogenic islet cells (human, U. Chicago)Human allogenic islet cells. Immunosuppression varies but may include prograf, celcept, sirolimus, prednisone. Dosage will vary per patient based on weight. Patients will receive immunosuppression medications while islet cells are functioning. | Drug | Transplant |
| Intraportal infusion of islet cellsIntraportal infusion of islet cell through the portal vein in the liver. | Procedure or surgery | Transplant |
Primary outcome
decrease in insulin requirement - Subjects able to maintain fasting blood glucose concentrations below 126 mg/dL and 2-hour post prandial levels below 180 mg/dL will be considered to be insulin independent.
Time frame: Monthly
decrease in incidence of hypoglycemic events
Time frame: Monthly
1 secondary outcome
absence of complications from the procedure and side effects of the medication
Time frame: Monthly
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
- Background: PubMed 10911004Shapiro AM, Lakey JR, Ryan EA, Korbutt GS, Toth E, Warnock GL, Kneteman NM, Rajotte RV. Islet transplantation in seven patients with type 1 diabetes mellitus using a glucocorticoid-free immunosuppressive regimen. N Engl J Med. 2000 Jul 27;343(4):230-8. doi: 10.1056/NEJM200007273430401.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piotr Witkowski, MD, Ph.D. principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 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 7 inclusion and 21 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: under way, not looking for participants, 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decrease in insulin requirement - Subjects able to maintain fasting blood glucose concentrations below 126 mg/dL and 2-hour post prandial levels below 180 mg/dL will be considered to be insulin independent. (time frame: Monthly). The study lists 2 primary outcomes in all. 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 NCT00160732, which also lists 1 linked publication.
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.