Implanted pec-01 cells capable of producing insulin according to new data presented from viacyte

WRITTEN BY: Todd Boudreaux

On October 3, 2019, ViaCyte presented positive preliminary data from the PEC-Direct trial. The data shows that their PEC-01 cells are capable of producing C-peptide in patients with Type 1 diabetes. C-petide is a biomarker for insulin and is used for assessing insulin-producing cells in patients with T1D.

PEC-01 cells are derived from stem cells and designed to mature into human pancreatic islet cells, including glucose-responsive insulin-secreting beta cells, following implant.

“ViaCyte is the first and only company in human clinical trials with a stem cell-derived islet replacement therapy candidate, and we are now the first to demonstrate production of C-peptide in patients receiving implanted stem cell-derived islets. These data show that our PEC-01 cells are functioning as intended when appropriately engrafted,” said Paul Laikind, Ph.D., Chief Executive Officer and President of ViaCyte. “While there is still more work to be done, this is an important milestone. We plan to present additional data in the near future.”

The PEC-Direct trial focuses on implanting PEC-01 cells in patients with T1D who are considered high risk for complications, including coma and death, and still requires the use of immunosuppressive drugs. High risk patients may have hypoglycemia unawareness, high glycemic variability or recurrent severe hypoglycemic episodes. Many of these patients are also eligible for cadaver islet transplants, however cadaver islet cells are in short supply. PEC-01 cells, which can be produced in a lab in potentially unlimited quantities, provide a potential solution to the supply issue.

ViaCyte is currently conducting another trial using the same PEC-01 cells called PEC-Encap, which would deliver the cells from an encapsulated device and would not require the use of immunosuppressants. The positive data reported from the PEC-Direct trial is good news for PEC-Encap as well.

“Today, ViaCyte presented preliminary data from its PEC-Direct therapy clinical trial, which showed that implanted cells, when effectively engrafted, are capable of producing insulin in people with Type 1 diabetes,” said Aaron J. Kowalski, Ph.D., president and CEO of JDRF. “Advancing research in beta cell replacement is a core pillar of JDRF’s research strategy and we have been a significant supporter of ViaCyte and other promising approaches. This progress is an encouraging milestone that shows the research being conducted today is bringing us one step closer to finding cures for Type 1 diabetes.”

Read the full press release here.

1 Like

Exciting! Thanks for posting. I’m particularly pleased to see they have successful encapsulation devices. I hope they have a reasonable lifetime! Even better if they can make cells that resist the immune system without encapsulation.

I know it’s a long way off with significant failure risks. Still excites me to see this kind or progress.

I’ve been following this company for awhile. It seems that the encapsulation devices being grafted (getting blood/oxygen/etc) is their biggest issue.

My understanding of this research is that it shows that the encapsulation device that does not protect the islet cells against the immune system (PEC-Direct) can get blood to the cells so they can survive (are grafted) when placed in the right spots. I suppose that is good, but I wish they’d made more progress by now on the encapsulation devices that will protect the cells from the immune system. I assume it will be trickier to get the cells the blood they need while protecting them from the immune system.

Folks that have the PEC-Direct cells will have to be on immuno-suppressants. The PEC-Direct trial started after the PEC-Encap trial. My personal opinion is that they decided they were taking on too much at once (finding the best site on the body for the devices and trying to find the best encapsulation device to protect the cells from the immune system) and the cells weren’t grafting.

Hopefully they’ve found the best spots to place these devices in the body and the PEC-Encap device will graft in those spots?

That is disappointing. I was on the regional JDRF chapter’s volunteer board about 12 years ago. One of my duties was giving canned presentations to potential donors about the most exciting research JDRF was supporting. There were several sources for functioning beta cells back then, but even a decade ago encapsulation was the biggest barrier. Here’s hoping the immune resistant cell line works!


I have been following this research and it looks very positive. I cannot wait to see if it bears fruit.