Type 1 Diabetes: People Age 18-70 Years Who Have Had a Kidney Transplant Greater Than Three Months Ago – Islet Cell Transplantation
Study Name: Treatment of Type 1 Diabetes by Islet Transplantation Into the Gastrointestinal Submucosa
Study Sponsors: National Institutes of Health
Principal Investigator: Andrew M. Posselt, MD, PhD
Who can sign up for this study? Basic inclusion and exclusion criteria include:
- 18-70 years old
- Patients who are able to commit to study visits and comply with study procedures
- >3 months post kidney transplant
- Currently taking a calcineurin inhibitor (CNI) based maintenance immunosuppression
- Stable renal function
- 1 episode of severe hypogylycemia in the past 12 months prior to study enrollment
- Cannot weigh more than 100kg or have a body mass index of >30kg/m2
- Cannot have an insulin requirement of >1.0 IU/kg/day or <15 U/day
- Cannot have previous (non-kidney) organ transplants, except a prior failed pancreatic graft
- Cannot have severe co-existing cardiac disease
What is this study about? The trial involves transplanting the glucose-controlling cells of a non-diabetic pancreas (the islet cells) into the space under the lining of your stomach or small intestine. The goal of this study is to use these transplanted islet cells to achieve sustainable insulin independence.
What will happen in this study? You will receive one islet cell transplant in your submucosal lining. A second islet cell transplant may be necessary in order to achieve insulin independence. You will also be required to attend periodic study visits at UCSF for three years after your transplant.
How long will this study last? 4-5.5 years
Reimbursement: The study will pay for any part of the transplant admission that would not be covered by your insurance. The study pays for the exams and special study procedures done during study visits. The study does not pay for any medications or lab tests you need for your kidney transplant, diabetes, or other health conditions. Unfortunately, the study is unable to reimburse you for parking or travel expenses. Because this is an NIH-sponsored trial, Medicare, if you have it, will pay for some of the procedures normally covered by the study, such as the islet transplant itself. If you do not have Medicare, you will not have to pay for them. You would only be responsible for paying what is considered standard of care for your kidney transplant or diabetes.
For more information please contact: Alissa Danford at 415-476-2575 or Alissa.firstname.lastname@example.org