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ISLET ALLO TRANSPLANTATION
 IN PATIENTS WITH KIDNEY GRAFT
IAK Patient info

OPEN ENROLLMENT

Pancreatic Islet Allo Transplantation

in Patients with a Kidney Transplant

Funded Internally

FOR PATIENTS AND Tx CENTERS
Brief Description for Patients

 

 

What do we  offer?

Many people with poorly controlled type 1 diabetes may eventually experience kidney failure and require dialysis. For these patients, getting a kidney and pancreas transplant at the same time is the best treatment option. However, for those who have already received a kidney transplant from a living or deceased donor, adding a pancreas transplant later (called Pancreas After Kidney Transplantation, or PAK) could be helpful.

 

There are also patients who have a well-functioning kidney transplant, take their medications as prescribed to prevent rejection, but still suffer from complications caused by their diabetes. These patients may not be good candidates for a full pancreas transplant, but they still need options for managing their diabetes and preventing further health issues.

We offer those patients participation in our clinical trial and receiving Islet after Kidney Transplantation (IAK). 

Today, we offer islets isolated from cadaveric donor pancreas but in the near future we will offer also stem cell derived islets for transplant. 

 

Inclusion criteria:​

In the first step, we need to check if you qualify to participate in the study.  Here are most important criteria every, which every candidate needs to meet: 

1. Age 18 to 68 years.

2. History of T1D.

3. More than 3 months after kidney transplantation. 

4. Stable renal graft function.

5. Bood type A or AB

 

Exclusion criteria:​

 

Here are the most important criteria which does not allow to participate in the study:

  • current cancer or neoplasm or PTLD after kidney transplant

  • any active chronic infection (BK, HBV, HCV, HIV, TB etc)

  • uncontrolled psychiatric disorder

1. Body mass index (BMI) > 30 kg/m2.

2. Positive screen for BK virus by polymerase chain reaction (PCR) in the blood sample performed at time of screening.

 

Inquires and enrollment

Preliminary results

  • We have performed over 50 islet transplants in patients with T1DM with good kidney function but suffering from hypoglycemia unawareness and  severe hypoglycemic episodes despite optimal insulin treatment                    (see our patient stories)

  • Now, we would like to test whether islet transplantation can be beneficial also for those patients with T1DM who has already received kidney transplant.

  • Up-to-date reports from other centers indicate beneficial effect  of islet in terms of the glucose control without increased risk for kidney graft function. 

  • We published already preliminary report in first two patients.  Pancreatic Islet After Kidney Transplantation. Two Case Report.  

  • Results in first 5 patients in the our center were presented during major transplant conferences in the US:

  • As example see below his CGM records before and after the islet transplant. 

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Blood glucose control prior to islet Tx: 

Each colored line represents blood glucose changes during 24 hours on a different day of the week.

  • blood glucose spikes over 400mg/ml on several occasions as well as                  A1c=8.8

  • life- threatening drops below 54mg/ml

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Blood glucose control after to islet Tx:

  • blood glucose levels in normal range of 80-180mg/ml                                                   A1c= 6.6

  • no more spikes over 200mg/ml,

  • no life- threatening drops below 54mg/ml

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