A recent study estimated there may be more than 500 million people worldwide who have diabetes. That’s an astounding figure and makes diabetes one of the largest chronic disease epidemics in human history.

One of the most serious consequences of untreated or uncontrolled diabetes is kidney damage. That can lead to fatigue, weakness, confusion, kidney failure, and even death. So, two decisions made by the CIRM Board today were good news for anyone already suffering from diabetes or kidney disease. Or both.

Artificial vein

The Board awarded almost $10 million to Humacyte to run a Phase 3 clinical trial of an artificial vein needed by people undergoing hemodialysis – that’s the most common form of dialysis for people with kidney damage. Hemodialysis helps clean out impurities and toxins from the blood. Without it, waste will build up in the kidneys with devastating consequences.

The artificial vein is a kind of bioengineered blood vessel. It is implanted in the individual’s arm and, during dialysis, is connected to a machine that moves blood out of the body, through a filter, and back into the body. The current synthetic version of the vein is effective but prone to clotting and infections, and must be removed regularly. All this puts the patient at risk.

Humacyte’s version – called a human acellular vessel, or HAV – uses human cells from donated aortas, which are seeded onto a biodegradable scaffold and grown in the lab to form the artificial vein. When fully developed, the structure is “washed” to remove all cellular tissue, leaving only a collagen tube. That is then implanted in the patient, and their own stem cells grow onto it, essentially turning it into their own tissue.

Earlier work

In earlier studies, Humacyte’s HAV was shown to be safer and last longer than current versions. As our President and CEO, Randy Mills, said in a news release, that’s clearly good news for patients:

“This approach has the potential to dramatically improve our ability to care for people with kidney disease. Being able to reduce infections and clotting, and increase the quality of care the hemodialysis patients get could have a significant impact on not just the quality of their life but also the length of it.”

There are currently almost half a million Americans with kidney disease who are on dialysis. Having something that makes life easier, and hopefully safer, for them is a big plus.

The Humacyte trial is looking to enroll around 350 patients at three sites in California: Sacramento, Long Beach, and Irvine.

Cost of dialysis

Not all people with diabetes need dialysis, but many need help managing blood sugar, especially those with type 1 diabetes. That’s where the $3.9 million awarded to ViaCyte comes in.

We are already funding a ViaCyte clinical trial that uses an implantable system with stem cell‑derived cells. The device measures blood flow, detects low blood sugar, and releases insulin to restore healthy blood sugar levels.

The new program uses a similar device called PEC‑Direct. Unlike the current version, PEC‑Direct allows a patient’s blood vessels to connect directly with the cells inside. ViaCyte believes this will improve engraftment and help the cells produce insulin more effectively.

Because the device allows direct vascularization, patients will need chronic immunosuppression to protect it. For that reason, it will treat people with type 1 diabetes who face high risk of severe hypoglycemic events due to hypoglycemia unawareness.

In a news release, Paul Laikind, PhD, ViaCyte’s President and CEO, said this approach could help those most at risk.

“This high‑risk patient group is the same group eligible for cadaver islet transplants, which work well but lack donor material. We believe PEC‑Direct could solve this by offering unlimited cells manufactured under cGMP conditions and a safer, more optimal delivery route.”

The Board also approved more than $13.6 million in Discovery program awards. You can see the winners here.