Diabetes Mellitus, Type 1NCT01630850
Islet Transplantation in Patients With "Brittle" Type I Diabetes
A 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 learn about the safety of islet transplantation for Type 1 diabetes mellitus, 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 70 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jun 2030
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Show all 15Show fewer
- 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.
- Other protocol related inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago Medical Center
Chicago, Illinois, 60637
Lindsay Basto, RN, BSN, 773-702-2504, Lindsay.Basto@uchospitals.edu
Piotr Witkowski, MD, PhD
About this study
The purpose of this study is to learn about the safety of islet transplantation for Type 1 diabetes mellitus, 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.
- Conditions
- Diabetes Mellitus, Type 1
- 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 may include remicade, thymoglobulin,prograf, solu-medrol, and cellcept. 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 |
|---|---|---|
| Allogenic islet cells (human, U. Chicago) | Experimental | Not 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.
HbAlc <7.0% and an absence of severe hypoglycemic events
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2030 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piotr Witkowski, MD, PhD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01630850
- Sponsor's protocol ID
- 11-0684
- Status last verified
- Dec 2025
- First submitted
- 26 Jun 2012
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang Q, Huang YX, Liu L, Zhao XH, Sun Y, Mao X, Li SW. Pancreatic islet transplantation: current advances and challenges. Front Immunol. 2024 Jun 3;15:1391504. doi: 10.3389/fimmu.2024.1391504. eCollection 2024.
PubMed 38887292Lee J, Yoon KH. Islet transplantation in Korea. J Diabetes Investig. 2024 Sep;15(9):1165-1170. doi: 10.1111/jdi.14264. Epub 2024 Aug 6.
PubMed 39105663Spence KT, Ladie DE. Islets Transplantation. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK562272/
PubMed 32965943Wang S, Du Y, Zhang B, Meng G, Liu Z, Liew SY, Liang R, Zhang Z, Cai X, Wu S, Gao W, Zhuang D, Zou J, Huang H, Wang M, Wang X, Wang X, Liang T, Liu T, Gu J, Liu N, Wei Y, Ding X, Pu Y, Zhan Y, Luo Y, Sun P, Xie S, Yang J, Weng Y, Zhou C, Wang Z, Wang S, Deng H, Shen Z. Transplantation of chemically induced pluripotent stem-cell-derived islets under abdominal anterior rectus sheath in a type 1 diabetes patient. Cell. 2024 Oct 31;187(22):6152-6164.e18. doi: 10.1016/j.cell.2024.09.004. Epub 2024 Sep 25.
PubMed 39326417Ghoneim MA, Gabr MM, El-Halawani SM, Refaie AF. Current status of stem cell therapy for type 1 diabetes: a critique and a prospective consideration. Stem Cell Res Ther. 2024 Jan 29;15(1):23. doi: 10.1186/s13287-024-03636-0.
PubMed 38281991El Nahas R, Al-Aghbar MA, Herrero L, van Panhuys N, Espino-Guarch M. Applications of Genome-Editing Technologies for Type 1 Diabetes. Int J Mol Sci. 2023 Dec 26;25(1):344. doi: 10.3390/ijms25010344.
PubMed 38203514
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Islet Transplantation in Patients With "Brittle" Type I Diabetes
- ClinicalTrials.gov ID
- NCT01630850
- Acronym / sponsor ID
- 11-0684
- Conditions
- Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- May 2012 (actual)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 28 Jun 2012 (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 learn about the safety of islet transplantation for Type 1 diabetes mellitus, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Allogenic islet cells (human, U. Chicago) | Experimental | Biological: Allogenic islet cells (human, U. Chicago), Procedure: Intraportal infusion of islet cells |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
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 may include remicade, thymoglobulin,prograf, solu-medrol, and cellcept. Dosage will vary per patient based on weight. Patients will receive immunosuppression medications while islet cells are functioning. | Biological | Allogenic islet cells (human, U. Chicago) |
| Intraportal infusion of islet cellsIntraportal infusion of islet cell through the portal vein in the liver. | Procedure or surgery | Allogenic islet cells (human, U. Chicago) |
Primary outcome
HbAlc <7.0% and an absence of severe hypoglycemic events
Time frame: 1 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.
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 9 Dec 2025.
- Background: PubMed 38887292Wang Q, Huang YX, Liu L, Zhao XH, Sun Y, Mao X, Li SW. Pancreatic islet transplantation: current advances and challenges. Front Immunol. 2024 Jun 3;15:1391504. doi: 10.3389/fimmu.2024.1391504. eCollection 2024.
- Background: PubMed 39105663Lee J, Yoon KH. Islet transplantation in Korea. J Diabetes Investig. 2024 Sep;15(9):1165-1170. doi: 10.1111/jdi.14264. Epub 2024 Aug 6.
- Background: PubMed 32965943Spence KT, Ladie DE. Islets Transplantation. 2023 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK562272/
- Background: PubMed 39326417Wang S, Du Y, Zhang B, Meng G, Liu Z, Liew SY, Liang R, Zhang Z, Cai X, Wu S, Gao W, Zhuang D, Zou J, Huang H, Wang M, Wang X, Wang X, Liang T, Liu T, Gu J, Liu N, Wei Y, Ding X, Pu Y, Zhan Y, Luo Y, Sun P, Xie S, Yang J, Weng Y, Zhou C, Wang Z, Wang S, Deng H, Shen Z. Transplantation of chemically induced pluripotent stem-cell-derived islets under abdominal anterior rectus sheath in a type 1 diabetes patient. Cell. 2024 Oct 31;187(22):6152-6164.e18. doi: 10.1016/j.cell.2024.09.004. Epub 2024 Sep 25.
- Background: PubMed 38281991Ghoneim MA, Gabr MM, El-Halawani SM, Refaie AF. Current status of stem cell therapy for type 1 diabetes: a critique and a prospective consideration. Stem Cell Res Ther. 2024 Jan 29;15(1):23. doi: 10.1186/s13287-024-03636-0.
- Background: PubMed 38203514El Nahas R, Al-Aghbar MA, Herrero L, van Panhuys N, Espino-Guarch M. Applications of Genome-Editing Technologies for Type 1 Diabetes. Int J Mol Sci. 2023 Dec 26;25(1):344. doi: 10.3390/ijms25010344.
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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.
Piotr Witkowski, MD, PhD 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 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 5 inclusion and 15 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 9 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.
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 <7.0% and an absence of severe hypoglycemic events (time frame: 1 year). 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 NCT01630850, which also lists 6 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 9 Dec 2025.