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ATLANTA — A new stem cell therapy could create a replacement pancreas — helping patients with Type 1 diabetics regulate their blood sugar levels, a new study reveals. Researchers with the Endocrine Society say it could end the need for some people with the condition to inject themselves with insulin.

People with Type 1 diabetes find their pancreas produces little to no insulin, but the therapy called PEC-Direct could create an alternative. The new study found people who used the treatment saw increases in the amount of C-peptide — a substance the pancreas makes alongside insulin — their body produces.

C-peptide and insulin are released from the pancreas at the same time in roughly equal amounts, which means measuring C-peptide can show how much insulin the body is making. It is the first time substantial increases in C-peptide have been shown in type 1 diabetics using a stem-cell based therapy.

The therapy could end the need for people with diabetes to use finger sticks, regularly inject themselves with insulin shots, and carry around bulky devices. Instead, it could give people a long-term source of insulin so their blood pressure levels can stay stable without the need for such devices. PEC-Direct also cuts the risk of someone accidentally cutting their blood sugar to dangerously low levels, which can happen when someone injects insulin.

How does PEC-Direct work?

The new device contains a pouch containing stem-cell derived pancreatic cells which mature into insulin-producing cells once implanted into the body.

The open device membrane allows blood vessels to grow into the device to contact the cells. Users have to take immunosuppressive drugs to avoid an immune reaction.

The treatment is meant for patients with high-risk Type 1 diabetes, who may be especially vulnerable to acute complications due to factors such as recurrent severe low blood sugar or frequent and extreme blood sugar fluctuations that are difficult to control.

Patients cut insulin usage by 70 percent

For the study, 10 people with Type 1 diabetes diagnosed at least five years before the start of the study received the stem cell therapy. Participants had hypoglycemia unawareness, which means they were not able to tell when their blood sugar levels were too low.

Initial data from one patient revealed a significant increase in the amount of C-peptide their body was producing, which led to improvements in their body’s ability to regulate blood glucose levels six months after starting PEC-Direct.

Since then, increased C-peptide levels were recorded in multiple patients, along with decreases in average blood sugar levels over the past three months by as much as 1.5 percent. The patients also saw the amount of insulin they needed to administer, falling by as much as 70 percent.

“This research represents the first instance in multiple patients of clinically relevant increases in C-peptide, indicative of insulin production, with a stem cell-based therapy delivered in a device,” says Dr. Manasi Sinha Jaiman, chief medical officer of ViaCyte Inc., which created the therapy, in a media release.

“The results suggest stem cell-based replacement therapy has the potential to provide blood glucose control and could one day eliminate the need for injecting or dosing insulin externally,” Jaiman adds. “The study provides further proof-of-concept that continued optimization of PEC-Direct has promise as a functional cure for Type 1 diabetes.”

The team presented their research at ENDO 2022, the Endocrine Society’s annual meeting.

South West News Service writer Gwyn Wright contributed to this report.

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