New study
in islet transplantation
 
Now, Open enrollment!

Allotransplantation for patients with T1DM

OPEN ENROLLMENT

A Safety, Tolerability and Efficacy Study of Sernova’s Cell Pouch™ for Clinical Islet Transplantation.

Funded by JDRF/Sernova

Dear Patient, 

I am writing to let you know about an opportunity to participate in a research study designed for patients with Type 1 Diabetes. This study is being conducted by myself, Dr. Piotr Witkowski at the University of Chicago.

This research study will assess the safety, tolerability and efficacy of the Sernova Cell Pouch™ that will be implanted under the skin, and transplanted with human pancreatic islets.

You may be eligible for this study if:

  • you are between the ages of 18-65,

  • have been diagnosed with Type 1 Diabetes for longer than 5 years, 

  • suffer from sudden and unpredictable drops of blood glucose leading to confusion or passing out despite the best medical treatment of insulin under the guidance of an experienced diabetologist.

If you are interested in learning more about this study, please review "Brief description" and "the patient information sheet" and contact Lindsay Basto, RN, BSN, Lindsay.Basto@uchicago.edu or 773-702-2504, for more information.

 

It is important to know that this letter is not to tell you to join the study.

It is your decision, and your participation is voluntary.

Whether you show interest, and participate in the study or not, it will have no effect on your treatment with your doctors. 

Thank you for your interest and consideration, 

 

Piotr Witkowski M.D. Ph.D​​

Information for Patients,

I am writing to let you know about an opportunity to participate in a research study designed for patients with Type 1 Diabetes. This study is being conducted by myself, Dr. Piotr Witkowski at the University of Chicago.

This research study will assess the safety, tolerability and efficacy of the Sernova Cell Pouch™ that will be implanted under the skin, and transplanted with human pancreatic islets.

You may be eligible for this study if:

  • you are between the ages of 18-65,

  • have been diagnosed with Type 1 Diabetes for longer than 5 years, 

  • suffer from sudden and unpredictable drops of blood glucose leading to confusion or passing out despite the best medical treatment of insulin under the guidance of an experienced diabetologist.

If you are interested in learning more about this study, please review "Brief description" and "the patient information sheet" and contact Lindsay Basto, RN, BSN, Lindsay.Basto@uchicago.edu or 773-702-2504, for more information.

 

It is important to know that this letter is not to tell you to join the study.

It is your decision, and your participation is voluntary.

Whether you show interest, and participate in the study or not, it will have no effect on your treatment with your doctors. 

Thank you for your interest and consideration, 

 

Piotr Witkowski M.D. Ph.D​​

Brief Description

 

Who can participate? Patients with type 1 diabetes who suffer from sudden and unpredictable drops of blood glucose leading to confusion or passing out despite the best medical treatment with insulin under the guidance of an experienced diabetologist.

 

What is the procedure? Instead of whole pancreas transplantation, you will have islet cells producing insulin  (isolated from a deceased donor pancreas) infused into a small devices- Sernova Pouch implanted under your skin. You may require 2 or 3 sequential islet transplants to obtain beneficial effect and still the curative outcome is uncertain.

There will be 3-6 superficial surgeries for your comfort performed when your are fully asleep (under general anesthesia). Surgery will include implantation of the pouches, transplantation of the islets and explantation of the pouches. It will involve the skin and muscles of your lower abdomen in the front, without getting into the abdominal cavity containing bowels. 

Several follow up visits will be required, for which the cost of travel will be reimbursed.

You will need to take anti-rejection mediation daily, which is the same requirement as for patients receiving a whole pancreas, kidney or heart transplantation.  

 

What are the risks?

Islet transplant may not work at all so you may not have a clinical benefit.

There is risk related to the repeated minor surgical procedure (pain, infection)

There is risk of side effects related to anti-rejection medications (infection, cancer, leukemia, kidney damage).

 

What are the benefits?

You will get access to the novel, minimal invasive intervention with a potential for improved blood glucose control and prevention of sudden blood glucose drops

You may benefit from being closely watched by the study team coordinators and Dr. Witkowski.

You will help scientists learn how to improve therapy for other patients with type 1 diabetes

Have there been any unexpected complications in the previous study?

No, there were no unexpected complications. Superficial infection was successfully treated with antibiotics.

Are there any preliminary results indicating potential for success?

Yes, results in small and large animals showed improved blood vessel development around the site of islet implantation and their improved survival. Results in first few patients in another center, showed also robust blood vessel development with some islet survival but without clinical benefits for patients. In the current study, we modified the protocol and hope for an improved outcome. See below.

Reference

1. Pepper AR , Pawlick LR , Gala-Lopez BL, , MacGillivary A, MazzucaDA, WhiteDA, Toleikis PM, Shapiro AMJ.Diabetes Is Reversed in a Murine Model by Marginal Mass Syngeneic Islet Transplantation. Using a Subcutaneous Cell Pouch Device. Transplantation 2105; 99, 11, 2294-2300.                                                                                                                                                         

 

 

2. Gala-Lopez BL, Pepper AR, Dinyari P, Malcolm AJ, 1, Kin T, L.R. Pawlick LR, 1, P.A. Senior PA, 1, Shapiro AMJ. Subcutaneous clinical islet transplantation in a prevascularized subcutaneous pouch – preliminary experience. CELLR4, 2016; 4 (5): e2132.                                                          

List of Surgical Procedures for the Sernova Cell Pouch™

 
Enroll Here! 
If, after reading the Brief Description of this study and the Information package, you are still interested in participating in this study, please proceed to the pre-screening questions below:
STEP 1.
Let's check first, if you qualify for the study:
- Have you had Type 1 diabetes for over 5 years?
- Are you over 18 and under 65 years old?
- Have you been suffering from sudden and unpredictable drops of blood glucose leading to confusion or passing out despite the best medical treatment of insulin under the guidance of an experienced diabetologist?
  • If one of the answers is no, you do not qualify and we would like to thank you for your interest and time. 
  • If you answered yes to all 3 questions, please proceed to the Step 2 below.
STEP 2.
Now, let's check if you might have a condition, which does not allow you to participate in the study:
- Is your BMI >30kg/m2?
-Do you have any kidney dysfunction with serum creatinine over 2mg/dl?
-Female: Are you pregnant, planning on being pregnant in the next 4  years, or breastfeeding?
-Male: Do you intend to procreate during the duration of the study or within 4 months after discontinuation?
-Have you encountered a presence or history of active infection including hepatitis B, hepatitis C, HIV, or Tuberculosis?
-Have you had an invasive Aspergillus, Histoplasmosis, or Coccidioidomycosis infection within last year?
-Do you have a history or malignancy/cancer (except for completely resected squamous or basal cell carcinoma of the skin)?
-Do you have any alcohol or substance abuse (except cigarettes)?
-Have you had a previous islet transplant?

If one of the answers is YES, we are sorry but you cannot participate in the study.

If you unsure, you can always contact us with additional questions for clarification:

Lindsay.Basto@uchicago.edu or fax 773-702-2127.

If all answers are NO to all questions above, please proceed to the step 3.

STEP 3.
Please download, fill out the questionnaire:

Patient Pre-Screening Questionnaire 

and send it by email to Lindsay.Basto@uchicago.edu or fax 773-702-2127.

STEP 4. 
Only for those individuals who received an invitation from us to proceed to this step!
Please download the form and take it to your diabetologist to be filled out, signed and emailed to Lindsay.Basto@uchicago.edu, or fax to 773-702-2127.

Physician Pre-Screening Questionnaire 

CONTACT:

 

 

 

 

 

 

 

 

Transplantation Institute

Clinical  Research Center

 

Islet and Kidney Transplantation

Manager, Lindsay Basto RN MSN 

Lindsay.Basto@uchospitals.edu

tel. (773) 702-2504

fax (773) 926-0671

 

Islet and Cell Processing and Research

Manager, Karolina Golab, PhD

kgolab@surgery.bsd.uchicago.edu


Transplantation Institute

University of Chicago Medicine

5841 S. Maryland Avenue

MC 5026, J-517

Chicago IL 60637

Polish-American Transplant Center

Clinical Coordinator

Patrycja Ulijaszyk RN 

Patrycja.Ulijaszyk@uchospitals.edu

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© 2018 by Kajetan Witkowski