What’s Happening?
A new Breakthrough T1D publication lays out the first clear preclinical testing and manufacturing roadmap for getting islet cell therapies for type 1 diabetes (T1D) into human clinical trials faster.
What is This Publication About?
Before any new therapy—including islet cell therapies for T1D—can move into in-human clinical trials, they need to go through rigorous testing in labs to confirm that they are likely to work and be safe in people. These are called preclinical studies.
In addition, therapies or drugs that are made in large enough quantities to support clinical studies need to undergo thorough validation and quality control testing to ensure that every pill, cell, or injection a person receives meets certain quality standards.
That’s where this publication authored by Breakthrough T1D staff and collaborators comes in. Islet cell therapies manufactured in labs are already in clinical trials. With more on the way, researchers need to think about the best approaches to preclinical studies and manufacturing to accelerate these therapies as quickly as possible.
In other words, we need a lot more cells to study these therapies in a lot more people. This paper is the roadmap to do that efficiently.
Islet Cell Therapies for T1D: Your Questions, Answered
Islet cell therapies are in clinical trials, and people are coming off external insulin. You may be wondering about how islet transplants work or how you or a loved one can get involved. Learn about what’s available now, eligibility requirements, recruiting clinical trials, and more.
This publication was spearheaded by Marjana Marinac, Pharm.D. (Associate Vice President of Regulatory Affairs) and Chanel Press, Ph.D. (Director of Regulatory Affairs), in addition to Esther Latres, Ph.D. (Senior Vice President of Research), Nicholas Mamrak, Ph.D. (Senior Scientist), and several expert collaborators across the field.
Why Does This Matter?
Manufactured islet cell therapies for T1D are still new. This publication takes general guidance from regulatory agencies like the U.S. Food and Drug Administration (FDA) and gives developers a roadmap for the types of studies, information, and data that regulators need to give the green light for clinical trials of manufactured islet cell therapies.
With a clear path to first-in-human studies, manufactured islet cell therapies can progress faster than ever. This is key to our Project ACT initiative to accelerate cell therapies on a large scale for anyone with T1D who wants them. This publication will help us get there.
Project ACT
Scientific progress takes time, resources, collaborations, and effort. To get islet cell therapies to people with T1D faster than ever, Breakthrough T1D launched Project ACT (Accelerate Cell Therapies) to simultaneously advance research, development, regulatory policies, access, and adoption of islet cell therapies that do not require broad immunosuppression.
What’s Next?
This paper will be presented as a poster at the International Society for Stem Cell Research 2026 Annual Meeting in Montreal, Canada, opening the doors to conversations with researchers in the field who can turn the roadmap into action. If you are attending, visit the poster during Poster Session 2 on Thursday, July 9, 2026, from 4:00 to 5:15 p.m.
In September, Breakthrough T1D and the National Institute of Diabetes and Digestive Diseases (NIDDK) are co-hosting a workshop that will bring together leaders from academia, industry, government, and the T1D community to discuss challenges and strategies around islet cell therapies, including manufacturing and nonclinical considerations. Learn more about the workshop and register today.
Key Takeaways
- Before clinical trials, researchers need to show regulators that manufactured islet cell therapies are safe and can make insulin.
- This publication outlines best practices to generate consistent and safe islet cell therapies, with quality control at every step.
- With a roadmap to follow, developers can more easily navigate challenges and accelerate islet cell therapies that meet requirements for regulators to agree to clinical studies.
