NIH-funded research Sbir 2 grant

A safer stem-cell treatment to replace insulin-producing pancreatic cells for diabetes

Official title: Development of a safer stem cell-based diabetes therapy via suicide gene-mediated ablation of proliferative cells

Funded at Regenerative Medical Solutions, INC. · NIH-11184143 · Data updated 2026-11-12

This project aims to create a stem-cell-derived therapy that restores insulin-producing cells for people with diabetes while adding a built-in safety switch to remove dangerous dividing cells.

More Diabetes research and trials

Quick facts

Grant typeSbir 2 grant
Study typeNIH-funded research
Funding institutionRegenerative Medical Solutions, INC.
NIH-funded
Lab location1 site (Chicago, United States)
Project startMarch 1, 2022
Project endJuly 31, 2027
Funding year2025
Award (this year)$915,136
NIH project number2R44DK133008-02
Project IDNIH-11184143 on NIH RePORTER

Who could benefit from this research

Could help

Ideal candidates would be people with insulin-dependent diabetes (especially type 1 diabetes) who have poor glucose control or severe hypoglycemia despite current treatments.

Less likely to help

People with non–insulin-dependent type 2 diabetes, those unable to receive cell-based therapies, or those who cannot take the antiviral drug ganciclovir may not benefit from this approach.

What this research studies

This effort is developing islet-like clusters made from engineered human induced pluripotent stem cells to replace the insulin-producing cells you’ve lost. The cells are modified to help them hide from the immune system so they won’t require lifelong immunosuppressive drugs. They also carry a FailSafe suicide-gene that lets doctors eliminate any dividing cells by giving the approved drug ganciclovir to reduce tumor risk. The goal is to manufacture these cells in larger amounts so more patients could receive an off-the-shelf transplant without chronic immune suppression.

Why it matters

Potential benefit: If successful, this approach could restore normal blood sugar control for people with diabetes without the need for lifelong immunosuppression and lower the risk of graft-related tumors.

How similar studies have gone: Donor pancreas and islet transplants have restored normal blood sugar in some patients and stem-cell-derived islets show promising preclinical results, but using a suicide-gene safety switch in humans is a newer, less-tested idea.

Where this research is happening

  • Regenerative Medical Solutions, INC.
    Chicago, United States
    Active

Researchers

  • Principal investigator: Cohen, Dena E — Regenerative Medical Solutions, INC.
  • Study coordinator: Cohen, Dena E

Related research

Other NIH-funded projects on the same topics.

About this research

  1. This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
  2. Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
  3. For full project details, budget, and progress reports, visit the official NIH RePORTER page.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.