Why are patients with protein in their urine or poor kidney function excluded?
Why are patients who have had cancer excluded?
Why are smokers excluded?
Why are people with recent heart attacks excluded?
Why are people taking steroids excluded?
Why can't I get an islet transplant if I've already had another type of transplant?
Why can't I get an islet transplant if I am pregnant or breast feeding?
What are the risks of immunosuppression?
Do you have plans to perform any islet transplant trials with living donors?
How long will the trial last?
Where is the trial being conducted?
What is the main purpose of the clinical trials?
How will patient safety be monitored?
Are there any risks involved?
What are the possible benefits?
What are the alternative treatments besides the one being tested in the clinical trial?
Do I have to pay for any part of the clinical trial?
What happens if I am harmed by the clinical trial?
Can I opt to remain on this treatment, even after termination of the trial?
Why are patients with protein in their urine or poor kidney function excluded?
Islet studies require that you take medications called immunosuppressants. These drugs keep your body from rejecting (destroying) the transplanted islets. Although the immunosuppressant medications currently used have fewer and less significant side effects than medications used in the past, some of the medications are “nephrotoxic,” meaning they can damage the kidneys. We do not want immunosuppressant medications to cause anyone to have kidney failure or need dialysis. As the medications that are used in islet transplant recipients continue to evolve, there may eventually be a combination that does not affect kidney function. At that time, the trials may be a safe option for people that already have kidney disease.
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Why are patients who have had cancer excluded?
Another side effect of some immunosuppressant medications is that there is a small, but increased, risk of developing cancer - particularly of the white blood cells. At this time, it is believed that patients with a previous history of cancer are more likely to be susceptible to this problem. Patients who have had skin cancer (basal or squamous, but not melanoma) completely removed can participate because once it is removed it is considered to be cured.
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Why are smokers excluded?
Smokers have a dramatically increased risk of cancer. Cancer is also one possible complication of long-term immunosuppressive medication. It is believed that including smokers in current clinical trials would increase their risk of developing cancer to an unacceptably high level.
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Why are people with recent heart attacks excluded?
Although the islet transplant involves a minor surgical procedure, it is still a surgical procedure. Data from many other clinical trials has shown that people who have had a heart attack within 6 months of having surgery are at a particularly high risk for further cardiac complications. People who have heart disease are at high risk to have heart problems when they have surgery.
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Why are people taking steroids excluded?
Steroids can elevate blood sugar levels, which would force the transplanted islets to work harder. If you take steroids, it is unlikely that an islet transplant will help you achieve insulin independence.
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Why can't I get an islet transplant if I've already had another type of transplant?
Current trials are designed to test islet transplantation in patients who have not had a previous transplant. However, it is expected that islet transplant trials will soon be extended to include people who have had previous kidney transplants.
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Why can't I get an islet transplant if I am pregnant or breast feeding?
The effects of immunosuppressants on the unborn child are unknown. It is for this reason that only women who are post-menopausal, surgically sterile, using effective birth control, or choosing to be celibate during the clinical trial may participate.
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What are the risks of immunosuppression?
Immunosuppressants can increase the chance that you will get a serious infection. Some of these infections can be life-threatening. It is also possible that these drugs could increase your risk for developing cancer. The names of the immunosuppressants used in the clinical trials can be found on the pages providing information about current clinical trials.
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Do you have plans to perform any islet transplant trials with living donors?
Currently, we are not performing any living donor islet transplants. However, we hope to someday offer this option for families that are interested.
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How long will the trial last?
Current islet transplant trials include a minimum of one year of follow-up tests. These typically consist of approximately 20 visits to the University of Minnesota to see the study doctors over the period of one year. Initially, the visits happen very frequently, but as the year goes on the visits are only once per month.
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Where is the trial being conducted?
The islet transplant itself occurs at the University of Minnesota Medical Center, Fairview. The post transplant monitoring occurs in the General Clinical Research Center, which is sponsored by the National Institutes of Health. Both are located on the University of Minnesota campus in Minneapolis.
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What is the main purpose of the clinical trials?
The main purpose of the clinical trials is to establish that islet transplantation is safe and effective for the treatment of type 1 diabetes. Also, continuing clinical trials are necessary to further improve the success rate of all aspects of islet transplantation.
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How will patient safety be monitored?
All clinical trials are overseen by the Food and Drug Administration, the University of Minnesota Institutional Review Board, a Data Safety and Monitoring Board, and agencies such as the Juvenile Diabetes Research Foundation that fund clinical trials.
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Are there any risks involved?
There are known possible risks and discomforts associated with this study. As with any medication or surgical procedure, there is also a risk that a rare or previously unknown side effect, drug interaction, or allergy can occur. This is particularly true in studies testing the safety and effectiveness of new drug combinations. You may have more problems as a result of participation in this islet transplant study than you would have if you continued insulin treatment alone. Immunosuppressants can increase the chance that you will get a serious infection. Some of these infections can be life-threatening. It is also possible that these drugs could increase your risk for developing cancer.
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What are the possible benefits?
There is no guarantee that an islet transplant will be successful. If the transplant is completely successful, the islets will produce insulin so that you will no longer need insulin shots or an insulin pump. Blood sugar will be controlled and you will not have insulin reactions. If the transplant is partially successful, you may benefit from more stable blood sugar control, need less insulin, and have fewer insulin reactions. Because improved control of blood sugar can slow the complications of diabetes (such as kidney disease, nerve damage, and blindness), you may benefit if your transplant is successful or partially successful.
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What are the alternative treatments besides the one being tested in the clinical trial?
Alternative treatment options for diabetes include insulin therapy or pancreas transplantation.
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Do I have to pay for any part of the clinical trial?
Immunosuppressants and medications to prevent infection after transplant will be given to you free of charge for the first year or until your islet cells stop working, whichever occurs first. You will not be charged for the islet cell transplant or the costs associated with hospitalization. You will not have to pay for any expenses associated with the tests and evaluations done at the study visits (lab testing, study appointments) that are required by this study.
After the trial period, you or your insurance company will have to pay for immunosuppressive medications.
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What happens if I am harmed by the clinical trial?
In the event that this research activity results in an injury, treatment will be available including first aid, emergency treatment and follow-up care as needed. Care for such injuries will be billed in the ordinary manner to you or your insurance company. If you think you have suffered a research related injury, please let the study physicians know right away.
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Can I opt to remain on this treatment, even after termination of the trial?
Currently, we do not have funding to pay for medications after the conclusion of the one-year post transplant follow-up period. It is possible that your insurance company may not pay for these medications, which can cost approximately $10,000 per year. If you are being considered for inclusion in a clinical trial, we will discuss this issue with you in more detail.
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