Type 1 Diabetes MellitusEXAXNCT01606475
Islet Transplant for Type 1 or Surgical Diabetes
A study testing Allogeneic islets of Langerhans in people with Type 1 Diabetes Mellitus and Hypoglycemia, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of islet transplants from human cadaver donors into type 1 or surgical diabetes mellitus patients who experience frequent acute or advanced chronic complications but do not qualify for other islet transplant trials. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes Mellitus, Hypoglycemia, Labile Diabetes
- What is being tested?
- Allogeneic islets of Langerhans
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Who may be able to join
- Male and female patients age 18 to 70 years of age.
- Ability to provide written informed consent.
- Mentally stable and able to comply with the procedures of the study protocol.
- Insulin-dependent diabetes mellitus
- Not otherwise eligible for an existing alloislet transplant protocol for type 1 diabetes mellitus
- Involvement in intensive diabetes management, defined by at least 3 injections daily or insulin pump therapy.
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- Meets at least one of the following criteria despite intensive efforts made in close cooperation with their diabetic care team:
- Significant hypoglycemia unawareness or glycemic lability on conventional insulin therapy, as evidenced by at least one of the following at screening:
- Clarke score > 4
- HYPO score >90th percentile (1047)
- Lability index (LI) >90th percentile (433 mM2/h/wk)
- 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 of equal to the 75th percentile (329)
- Progressive secondary complications as defined by end-stage renal disease necessitating dialysis or renal transplantation (eligible for islet after kidney or simultaneous islet kidney transplant) AND islet transplant appears to provide a more satisfactory benefit to risk ratio compared to pancreas transplantation (eg high surgical risk)
Who cannot join
- HbA1c >10%.
- Untreated proliferative diabetic retinopathy.
- Uncontrolled Hypertension (SBP>160 or DBP>100)
- For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study.
- Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB.
- Any history of malignancy except for completely resected squamous or basal cell carcinoma of the skin.
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- Receiving treatment for a medical condition requiring chronic use of systemic steroids, except for use of prednisone <5 mg per day for kidney transplant recipients or physiologic hydrocortisone replacement.
- Persistent elevation of liver function tests at the time of study entry. Persistent SGOT (AST), SGPT (ALT), Alk Phos or total bilirubin, with values >1.5 times normal upper limits will exclude a patient.
- Severe co-existing cardiac disease, characterized by any one of these conditions:
- recent myocardial infarction (within past 6 months).
- evidence of ischemia on functional cardiac exam within the last year.
- left ventricular ejection fraction <30%.
- If diabetes is secondary to total pancreatectomy, participants will be considered only if >1 year out from surgery, medically stable, without severe issues with bowel function or pain management that may interfere with safe completion of the trial.
- History of alcoholism
- Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Human Alloislet Transplant for Type 1 or Surgical Diabetes Mellitus With Complications
The purpose of this study is to evaluate the safety and efficacy of islet transplants from human cadaver donors into type 1 or surgical diabetes mellitus patients who experience frequent acute or advanced chronic complications but do not qualify for other islet transplant trials. Under this protocol, patients may receive intraportal alloislet transplant under one of the following scenarios:
- islet transplant alone
- simultaneous islet-kidney transplant, or 3)islet after kidney transplant.
Read the detailed description
The overall objective of this study is to evaluate the efficacy of islet allotransplants for labile diabetes mellitus in patients who do not meet standard inclusion/exclusion criteria for any other islet transplant trials in the US and are not good candidates for a pancreas transplant. We expect that this will include patients who have surgical diabetes (total pancreatectomy) rather than type 1 diabetes, patients who are highly sensitized (PRA>20%), and patients who have had prior failed pancreas transplantation. These patients may have equally severe hypoglycemia, glucose lability, and/or severe microvascular complications, but are excluded from standard islet transplant trials currently available in the U.S.
- Being tested
- Allogeneic islets of Langerhans
- Keywords
- Islet transplant, Diabetes Mellitus, Hypoglycemia
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia, Kidney Failure, Chronic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic islets of LangerhansBiological
Also called Islets
Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernhard J Hering, M.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606475
- Sponsor's protocol ID
- 1108M03061
- Acronym
- EXAX
- Status last verified
- Aug 2025
- First submitted
- 23 May 2012
- Last updated
- 14 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Alloislet Transplant for Type 1 or Surgical Diabetes Mellitus With Complications
- ClinicalTrials.gov ID
- NCT01606475
- Acronym / sponsor ID
- EXAX / 1108M03061
- Keywords
- Islet transplant, Diabetes Mellitus, Hypoglycemia
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- First posted
- 25 May 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 evaluate the safety and efficacy of islet transplants from human cadaver donors into type 1 or surgical diabetes mellitus patients who experience frequent acute or advanced chronic complications but do not qualify for other islet transplant trials. Under this protocol, patients may receive intraportal alloislet transplant under one of the following scenarios:
- islet transplant alone
- simultaneous islet-kidney transplant, or 3)islet after kidney transplant.
Detailed description
The overall objective of this study is to evaluate the efficacy of islet allotransplants for labile diabetes mellitus in patients who do not meet standard inclusion/exclusion criteria for any other islet transplant trials in the US and are not good candidates for a pancreas transplant. We expect that this will include patients who have surgical diabetes (total pancreatectomy) rather than type 1 diabetes, patients who are highly sensitized (PRA>20%), and patients who have had prior failed pancreas transplantation. These patients may have equally severe hypoglycemia, glucose lability, and/or severe microvascular complications, but are excluded from standard islet transplant trials currently available in the U.S.
Study design
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male and female patients age 18 to 70 years of age.
- Ability to provide written informed consent.
- Mentally stable and able to comply with the procedures of the study protocol.
- Insulin-dependent diabetes mellitus
- Not otherwise eligible for an existing alloislet transplant protocol for type 1 diabetes mellitus
Key exclusion criteria (15 listed)
- HbA1c >10%.
- Untreated proliferative diabetic retinopathy.
- Uncontrolled Hypertension (SBP>160 or DBP>100)
- For female participants: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study.
- Active infection including hepatitis B, hepatitis C, HIV, or TB as determined by a positive skin test or clinical presentation, or under treatment for suspected TB.
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 |
|---|---|---|
| Allogeneic islets of LangerhansAlso: IsletsUp to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight. | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2025.
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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.
Bernhard J Hering, M.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allogeneic islets of Langerhans in people with Type 1 Diabetes Mellitus and Hypoglycemia, run by University of Minnesota 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 13 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: status not confirmed, as of the sponsor's last update on 14 Aug 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?
Results are not available in the source record.
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.
Where can I read the original study information?
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 14 Aug 2025.