ViaCyte is a California-based regenerative medicine company that is developing products they hope will “free patients with type 1 and type 2 diabetes from long-term insulin dependence”.

The company was initially established in 1999 under the name “Novocell” and was renamed to ViaCyte in 2010. ViaCyte has received millions of dollars in funding from various organizations, including the Juvenile Diabetes Research Foundation (JDRF).

The Technology

The company has two type 1 diabetes-specific products in their pipeline that are already undergoing human clinical trials. The products consist of implanted stems cells in an encapsulation device. The cell delivery system can be implanted through a simple outpatient surgical procedure.

Once the cells are fully mature, they will be able to secrete insulin (among other hormones) in response to blood glucose levels. If successful, it is expected that patients will no longer need to administer insulin.

The encapsulated stem cells offer several advantages over traditional islet transplants. The cell supply is virtually unlimited (see below), and the grafts can be removed from the patient if needed for any reason. Excitingly, one of the products (PEC-Encap) appears to be functional without the need for immunosuppressive drugs.

The Cells

The ViaCyte products are developed using stems cells. Stem cells are cells that can mature into different cell types under different conditions. Specifically, the products were developed using the embryonic stem cell line called CyT49.

The CyT49 cells were originally isolated in 2008. The cells can be frozen and later thawed, expanded, and differentiated into different cell types. This is considered an “inexhaustible human embryonic stem cell line.” This means there is no need to obtain any more cells from human tissues; the cells are already available and can be propagated indefinitely.

ViaCyte developed a specific protocol to differentiate these stem cells into beta cell progenitor cells, pancreatic endoderm cells (PEC-01). “PEC-01 grafts mature over the course of several months to form islet-like tissue capable of regulating blood glucose,” the researchers explain.

PEC-Direct

PEC-Direct is a product developed specifically for patients with “high-risk” type 1 diabetes. This refers to those patients who may be especially vulnerable to acute complications due to factors like hypoglycemia unawareness, recurrent severe hypoglycemia, and/or frequent and extreme blood glucose fluctuations that are difficult to control.

The main disadvantage of this product is that (unlike the PEC-Encap, discussed below), immunosuppressive drugs must be administered to prevent the immune system from attacking the cells.

Because PEC-Direct patients must be on immunosuppressive medications, there will be a certain risk/benefit scenario for this treatment, and as a result ViaCyte has identified high-risk T1D patients as the most appropriate candidates for the PEC-Direct product candidate. ViaCyte believes that pursuing the PEC-Direct product candidate will be the most rapid way to get the invaluable PEC-01 cell replacement therapy to those who need it most, the high-risk T1D.

You can learn more about the PEC-Direct product here.

PEC-Encap

PEC-Encap (VC-01) also utilizes the PEC-01 cells. The major difference from the PEC-Direct product is the utilization of the Encaptra cell delivery system, which is a “proprietary immune-protecting and retrievable encapsulation medical device.” This means that patients receiving the PEC-Encap implant will not require the use of immunosuppressive drugs.

Essentially, if successful, PEC-Encap would represent a “functional cure” for type 1 diabetes.

You can learn more about the PEC-Encap product here.

Early Trials

Both the PEC-Direct and PEC-Encap products have demonstrated their efficacy in regulating blood glucose levels in mice. Human clinical trials are currently ongoing for both products, and the early results appear promising.

Specifically, the research team reports that early safety studies demonstrate that the systems are well-tolerated. Excitingly, early studies show that the Encaptra device appears to be effective in protecting the cells against immune attack.

You can learn more about ongoing and new clinical trials here.

Next Steps

Researchers are working to utilize incoming trial data to assess and improve product performance. We will continue to update this page with any relevant news about these products.

Learn More

Here are some other posts discussing ViaCyte technologies from Diabetes Daily:

Is a Functional Cure for Type 1 Diabetes on the Horizon?

Implantable Insulin Capsule Begins Human Trials in Type 1 Diabetes

The Pursuit of Curing Type 1 Diabetes Through Stem Cell Therapy

ViaCyte In the News

Here are some major recent press releases about ViaCyte technologies:

Early Data Demonstrates Insulin Production in Humans

Start of European Clinical Trial

Early Clinical Trial Data

Read more about cure research, stem cells, type 1 diabetes.