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Transplant Center
University of Minnesota Medical Center, Fairview
Phillips-Wangensteen Building
Second Floor, Clinic 2A
516 Delaware St. SE
Minneapolis, MN 55455

For patient appointments:
612-672-7270

For provider referrals:
612-625-9922 or 800-478-5864
(Heart and lung)
612-625-5115 or 800-328-5465
(All other organs)
  

Islet transplant clinical trials

How to participate in our clinical trials
All clinical trials at the Schulze Diabetes Institute at the University of Minnesota have inclusion and exclusion criteria. These are the medical or social standards that determine whether a person may or may not be allowed to enter a clinical trial. These criteria are based on such factors as age, gender, the type and stage of disease, previous treatment history, and other medical conditions. It is important to note that inclusion and exclusion criteria are not used to personally reject people. Instead, they identify potential subjects and keep them safe.

Inclusion Criteria
In order to qualify for an islet transplant trial at the University of Minnesota, you must meet the following criteria:

  • Have  had Type 1 Diabetes for more than five years
  • Be age 18 to 68
  • Be checking blood sugar at least three times per day
  • Be administering at least three insulin injections per day, or using an insulin pump
  • Have a complication from diabetes, (such as not having warning symptoms when blood sugar is low)
  • Have seen a diabetes care team at last three times in the last year
     
If your application demonstrates that you meet these criteria, we will contact you. At that point, we may conduct additional screening to further determine your eligibility. If you are interested in becoming a possible participant call: 612-626-3016 or email us at dittinfo@umn.org


Exclusion Criteria
Any of the following situations will exclude you from being able to participate in an islet transplant trial at the University of Minnesota at this time:

  • Females who are currently pregnant, intend to become  pregnant, or are presently breast-feeding
  • Males who intend to father children
  • Have an active or past infection with hepatitis C, hepatitis B, HIV, or TB (or under treatment for suspected TB)
  • Have any history of cancer except for adequately treated skin cancer
  • Have had a heart attack within the past 6 months or extensive coronary artery disease
  • Are under treatment for a medical condition requiring chronic use of steroids such as prednisone

Please do not be discouraged if you do not currently meet these criteria. We are working to expand the criteria so that in the future everyone with type 1 diabetes can benefit from an islet transplant, if they are eligible and wish to do so.


If you are not eligible to participate in an islet transplant clinical trial, you may want to consider getting a pancreas transplant.

Outcomes
Since 2000, we have completed 4 islet transplant trials involving 32 patients with type 1 diabetes.  All of the participants suffered from hypoglycemia unawareness before their transplant. This means they could not sense when their blood glucose was getting too low. This dangerous condition persisted despite the fact that these patients made intensive efforts to improve their blood glucose control with their diabetes care teams.

Following are the outcomes of the transplant trials:

  • All participants had immediate protection from hypoglycemia (low blood glucose) after their transplant.  
  • More than 80 percent of our transplant recipients are still protected from severe hypoglycemia five years after their transplant. 
  • About 90 percent of our recipients have become insulin-independent after their transplant; more than 50 percent have maintained insulin independence five years after their transplant. 
  • None of our trial participants has experienced a serious, unexpected adverse event related to the islet transplant procedure or the immunosuppressive drugs they are taking. These drugs help suppress the body's immune system so that it will not attack the new islet cells as foreign invaders. 


Previously, such results were only been attainable by having a pancreas transplant.