The SA Journal Diabetes & Vascular Disease Vol 12 No 2 (December 2015)

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82 VOLUME 12 NUMBER 2 • NOVEMBER 2015
RESEARCH ARTICLE SA JOURNAL OF DIABETES & VASCULAR DISEASE
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Pearinda 4. Each tablet contains 4 mg perindopril tert-butylamine. Reg. No.: RSA S3 41/7.1.3/0649. NAM
NS2 10/7.1.3/0476. Pearinda 8. Each tablet contains 8 mg perindopril tert-butylamine. Reg. No.: RSA S3
41/7.1.3/0650. NAM NS2 10/7.1.3/0477. For full prescribing information, refer to the package insert approved
by the Medicines Control Council, April 2009. Pearinda Plus 4. Each tablet contains 4 mg perindopril tert-
butylamine and 1,25 mg indapamide. Reg. No.: RSA S3 41/7.1.3/0633. NAM NS2 10/7.1.3/0611. For full
prescribing information, refer to the package insert approved by the Medicines Control Council, April 2010.
1) Department of Health website http/ – Accessed on 26/03/2015.PAD168/04/2015
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Encapsulated beta-cell replacement therapy for type 1 diabetes
Beta-cell encapsulation therapy is a procedure that involves
implantation of cells, contained in a protective barrier, with
the ability to secrete insulin into the body in a glucose-responsive
manner.
On 17 July 2014, the Juvenile Diabetes Research Foundation
(JDRF) announced that its partner, ViaCyte, Inc, had filed an
Investigational New Drug (IND) application with the US Food and
Drug Administration (FDA), seeking to conduct a phase 1 and 2
clinical trial in patients with type 1 diabetes. The purpose of this trial
is to evaluate the safety and efficacy of the VC-01 product, a stem
cell-derived, encapsulated-cell replacement therapy. In addition to
the IND, ViaCyte also submitted a medical device master file (MAF)
to the FDA regarding the Encaptra® drug-delivery system, a device
component of the VC-01 product.
Beta-cell encapsulation therapy is a procedure that involves
implantation in a protective barrier of cells with the ability to
secrete insulin into the body in a glucose-responsive manner. The
advantage of these encapsulated beta-cells is that they can assess
the patient’s blood glucose level and secrete the correct amount
of insulin, while their barrier protects them from being destroyed
by the autoimmune system.More importantly, encapsulation therapy
also helps prevent the requirement of lifetime administration of
powerful and toxic immunosuppressive drugs designed to protect
the newly introduced islets from the immune system.
VC-01 therapy is the combination of PEC-01 cells (a proprietary
pancreatic endoderm cell product derived through directed
differentiation of an inexhaustible human embryonic stem cell)
and an Encaptra drug-delivery system (a proprietary immune-
protecting and retrievable encapsulation medical device.) The
VC-01 combination product is expected to be implanted under the
skin of the patient through a simple out-patient surgical procedure.
Once inside the body, the cells are expected to differentiate and
become mature pancreatic cells with the ability to produce and
secrete insulin based on the patient’s glucose level.
Based on pre-clinical studies, VC-01 therapy has been shown to
be effective in mice. Normal blood glucose levels for mice range
from 160–200 mg/dl (8.88–11.1 mmol/l) , which are considered
hyperglycaemic in humans. However, when the mice received
the VC-01 combination product, their blood glucose levels were
closer to human levels. In addition, when these mice received STZ,
a chemical designed to kill native mouse beta-cells, the mice still
maintained their blood glucose levels.
Study of the synergy of cell therapy and the Encaptra medical
device also showed positive results. In the mouse study, host blood
vessels began to grow into the VC-01 combination product at
week four, supplying a steady amount of oxygen and nutrients
to PEC-01 cells. At week eight, vascularisation developed quickly.
Meanwhile, the Encaptra device protected the PEC-01 cells from
immune rejection with a protective permeable membrane.
The VC-01 cell replacement therapy could be a potential cure
for type 1 diabetes.
References
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