New study
in islet transplantation
Sernova Pouch Study
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
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 a whole pancreas transplantation, you will have islet cells producing insulin (isolated from a deceased donor pancreas) infused into a small device- Sernova Cell 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 diabetic animals were positive. Improved blood vessel development was shown in the Cell Pouch and the site of islet transplantation. The survival of islets was demonstrated within the Cell Pouch with the ability to produce insulin and other hormones that are known to control blood sugar. The animals with diabetes also showed an improvement in control of blood sugar during the studies. The blood sugar control was lost after the Cell Pouches were intentionally removed. Results obtained from a few patients tested for the first time in another center, showed the Cell Pouch was safe. The islets transplanted into the Cell Pouch were also shown to make insulin and other hormones (see picture below), but this initial test did not show clinical benefit for the patients. Based on what was learned in the first few patients, the protocol was modified for the current study for a potential improvement in patient clinical outcomes. You can read published reports- links 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, Kin T, L.R. Pawlick LR, Senior PA, Shapiro AMJ. Subcutaneous clinical islet transplantation in a prevascularized subcutaneous pouch – preliminary experience. CELLR4, 2016; 4 (5): e2132.
