Advances and Shortcomings in Cell Therapy for Type 1 Diabetes, With Archana Sadhu, MD

Although their widespread clinical use is still some distance away, cell therapy for type 1 diabetes (T1D) has made great strides in the last few years and continues to grow in promising directions.1

This presentation was given at the American Association of Clinical Endocrinology (AACE) Annual Meeting 2026 in Las Vegas, NV, by Aaron Kowalski, PhD, chief executive officer at Breakthrough T1D, and moderated by Archana Sadhu, MD, director of transplant endocrinology, pancreas transplantation, and the system diabetes program at Houston Methodist. In an exclusive interview with HCPLive, Sadhu discusses the timeliness of this presentation and the need for education on the future of gene-based T1D therapies.

“We already have islet cell transplant available, but now we’re embarking on new stem cell-derived islets that should be a clinical option very, very soon,” Sadhu told HCPLive. “We want to educate all of our endocrinologists and the endocrine care team on which patients would qualify for these therapies, where you go to offer them for your patients, and an overview of how far we’ve come. And we’ve come a long way.”

Donor-derived islet cells are still the primary source of available therapy for T1D; however, their efficacy is limited in that several donor pancreases are often needed for a single transplant. Although it works on an individual basis, this process is not scalable due to an ongoing shortage of donor organs. To this end, most cell therapies are limited to patients with unstable blood sugar management and severe hypoglycemia.1

To this end, stem cell transplant is a growing focus of the therapeutic industry. The process involves injecting lab-grown pancreatic beta cells into patients, enabling restoration of the body’s insulin production. If administered early in T1D development, stem cell transplant could potentially cease insulin dependency outright.2

In 2025, the first successful stem cell therapy was completed in a patient with T1D. In a publication in World J. Stem Cells, the investigative team reported the patient’s complete insulin independence in 3 months after receiving autologous iPSC-derived islet-like cells. Though this success is only preliminary and requires further research to validate its mechanics and confirm that this insulin independence is maintained, the trial marks a substantial step forward in 1 of the more promising avenues for cell therapy in T1D.2

However, the shortcomings and roadblocks of islet cell therapy are also applicable in stem cell transplants, limiting their practical application. Foremost among these issues is immune system modulation – T1D is characterized by the immune system directly attacking the body’s beta cells. Given that stem cell transplantation relies on replacing these cells, any successful procedure will need to account for this autoimmune angle, either by protecting the administered cells or by altering the immune response. Various techniques have been suggested and tested towards this end, but currently, cell therapy still largely relies on in-depth patient selection.1,2

“The biggest thing we’ve learned is that patient selection is important – each of these therapies have different risks and different benefits, and choosing the right patient is key,” Sadhu said. “You need to select someone who can follow the tight protocols after transplant to comply with a tedious medication regimen to a T, to make sure that there’s no rejection and other complications. But when you have that patient, they’re going to get the best solution in terms of diabetes treatments.”

Editors’ Note: Sadhu reports disclosures with the Houston Methodist Academic Institute, Weill Cornell Medicine, and Texas A&M Health Sciences.

References

1. Kowalski A. Cell Therapies in T1D: Are we close to cures? Presented at the American Association of Clinical Endocrinology Annual Meeting 2026, Las Vegas, NV. April 22-24, 2026.

2. Kumar D, Tanwar R, Gupta V. First-ever stem cell therapy restores insulin independence in type 1 diabetes: A medical milestone. World J Stem Cells. 2025;17(7):106856. doi:10.4252/wjsc.v17.i7.106856