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ISLET ALLO TRANSPLANTATION
 IN PATIENTS WITH KIDNEY GRAFT
IAK Patient info

OPEN ENROLLMENT

Pancreatic Islet Allo Transplantation

in Patients with Stable Kidney Graft Function

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Funded Internally

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Brief Description for Patients

 

 

What do we  offer?

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Many patients with poor controlled type 1 diabetes end up with kidney failure and need dialysis. Simultaneous kidney and pancreas transplantation remains the best therapeutic option for them. Those, who received kidney alone from a live or decease donor, may benefit from Pancreas after Kidney Transplantation (PAK). 

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However, there are still patients with a very good kidney transplant function, who take their anti-rejection medication properly but they suffer from progressive complications caused by poorly controlled diabetes, and who are not good candidate for a whole pancreas transplant. 

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

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Inclusion criteria:​

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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: 

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1. Age 18 to 68 years.

2. History of T1D.

3. More than 3 months after kidney transplantation. 

4. Stable renal function. 

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Exclusion criteria:​

 

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

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  • History or current ancer or neoplasm or PTLD after kidney transplant

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

  • uncontrolled psychiatric disorder

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1. Weight more than 90 kg or body mass index (BMI) > 30 kg/m2.

2. Insulin requirement of >1.0 IU/kg/day or <15 U/day.

3. Untreated or unstable proliferative diabetic retinopathy.

4.. Proteinuria (albumin/creatinine ratio or ACr > 300 mg/g) of new onset since kidney transplantation..

5.. Severe co-existing cardiac disease, characterized by any one of these conditions: 

 

a. Recent MI (within 6 months);

b. Evidence of ischemia on functional cardiac exam within the last year;

c. Left ventricular ejection fraction < 30%; or

d. Valvular disease requiring replacement with prosthetic valve.

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

 

Logistics Overview

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Preliminary results

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  • 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. 

  • So far, we performed islet transplants in 2 kidney recipients in our center. We have published already preliminary report in Polish language in order to introduce this new procedure  to physicians and patients in Poland. Version in English translation is available here:   Pancreatic Islet After Kidney Transplantation. Two Case Report. Forum Nephrologiczne. 2018. 11, 1, 43-49. 

  • Subsequently, we helped to open a new islet transplant Center in Gdansk, Poland, where first 2 patients with stable kidney graft function received islet transplant the end of  October of 2018 and in March of this year. Over last 5 months the first patient lowered his daily  insulin requirements in 50%.. More importantly  patient improved his overall glucose control significantly- A1c declined from 8.0 to 6.6. However, as he main benefit, patient stopped having severe hypoglycemic episodes and stop fearing of sudden death caused by that. His and his family quality of life improved substantially, patient now seeks to be active in his community running for a public office in his neighborhood. 

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  • See below his CGM records before and after the islet transplant. 

Poland Pre islet Tx.jpg

Blood glucose control prior to islet Tx: 

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

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

  • life- threatening drops below 54mg/ml

After islet Tx.jpg

Blood glucose control after to islet Tx:

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  • 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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