Encellin Partners with Breakthrough T1D to Advance Immune-Protected Cell Therapy for Type 1 Diabetes
September 22, 2026 / Business wire
SAN FRANCISCO, NEW YORK, MONTREAL, Sept. 22, 2026 — Encellin, Inc., a clinical-stage biotechnology company developing Encapsulated Cell Replacement Therapy (ENCRT), today announced a partnership with Breakthrough T1D, the leading global Type 1 Diabetes (T1D) research and advocacy organization, and an award through its Industry Discovery and Development Partnership (IDDP) program to support the advancement of Encellin’s ENCRT-103-hPI clinical program in T1D.
The new trial (NCT07680673) will bring ENCRT-103-hPI, Encellin’s immune-protected implant configuration, into the clinic. ENCRT-103-hPI builds on the successful completion of NCT06408311, Encellin’s first-in-human Phase 1 study, which demonstrated non-fibrotic tissue integration, vascularization, and viable human islets within retrieved ENC-201 implants. ENCRT-103-hPI is designed to test whether this next-generation implant can safely support and protect transplanted islets in people with T1D, and will be conducted in Canada. The planned study will assess safety, tolerability, and local tissue response, including vascular integration around the implant, the ENCRT membrane’s ability to exclude immune cells, and survival of the donor islets.
For people living with T1D, replacing the insulin-producing cells lost to the disease has the potential to address the underlying disease rather than continually managing its consequences. Today, however, islet transplantation requires systemic immunosuppression to protect transplanted cells. Encellin is developing ENCRT with the long-term goal of enabling cell replacement therapies that can survive and function while being protected from the immune system, without the need for immunosuppression.
“People with Type 1 Diabetes manage their disease every hour of every day. Our vision is a future where replacing the cells lost to T1D and protecting them instead of suppressing the patient’s immune response can become a practical therapeutic option for many more people,” said Crystal Nyitray, PhD, founder and CEO of Encellin. “This study represents an important step toward that goal. We are grateful to Breakthrough T1D for sharing that vision and for supporting the careful clinical work required to determine whether an immune-protected cell replacement approach can ultimately deliver meaningful benefit to people living with T1D.”
“Islet Cell replacement has enormous potential to transform the lives of people with Type 1 Diabetes, but protecting transplanted insulin-producing cells from the immune system without the need for immune suppressive drugs remains one of the field’s central challenges,” said Asja Guzman, Associate Director at Breakthrough T1D. “Breakthrough T1D is committed to advancing approaches to help overcome this barrier. Encellin’s clinical program provides an opportunity to validate a retrievable, immune-protective device can safely support the long-term function of transplanted islets in people with T1D, and we are pleased to collaborate in this next stage of development.”
About the Encellin–Breakthrough T1D Collaboration
Breakthrough T1D’s Industry Discovery and Development Partnership program supports promising industry programs with the potential to accelerate the development of therapies for the treatment, prevention and cure of T1D. Under the 24-month, $2.5 million award, Breakthrough T1D will support advancement of Encellin’s ENCRT-103-hPI clinical program, including the planned Phase 1 study in adults with T1D.
About Encellin
Encellin, Inc. is a clinical-stage biotechnology company developing Encapsulated Cell Replacement Therapy (ENCRT), a retrievable thin-film platform designed to enable therapeutic cells to survive and function in the body. Encellin’s lead clinical programs are focused on advancing cell replacement approaches for people living with Type 1 Diabetes.
For more information, visit www.encellin.com.
About Breakthrough T1D, Formerly JDRF
As the leading global Type 1 Diabetes research and advocacy organization, Breakthrough T1D helps make everyday life with Type 1 Diabetes better while driving toward cures. We do this by investing in the most promising research, advocating for progress by working with government to address issues that impact the T1D community, and helping educate and empower individuals facing this condition.
Forward-Looking Statements
This press release contains forward-looking statements regarding the potential benefit of the ENCRT platform, including its ability to address fibrosis, immune protection, viability of human cells, and potential applications in Type 1 Diabetes and other endocrine or metabolic diseases, development plans and vision for future programs or potential therapeutic applications. The ENCRT platform’s development for use with allogeneic islets in patients with Type 1 Diabetes is being evaluated in clinical studies, and its safety and effectiveness for this use has not been established. These statements are based on current expectations and are subject to risks and uncertainties including risks associated with early-stage clinical development, the possibility of unfavorable preclinical or clinical results, regulatory review and approval process, manufacturing challenges, and the ability to advance programs as planned. Actual results may differ materially from those expressed or implied. Encellin undertakes no obligation to update forward-looking statements contained in this press release as a result of new information or future events.
On January 6th, 2026, Encellin (California, Quebec) reported positive interim results of its Phase 1 clinical trial of encapsulated islets in people with type 1 diabetes (T1D), which is being carried out in Toronto and Montreal.
Trial Details:
In Encellin’s trial, cadaveric human donor islets are being encapsulated in Encellin’s Encapsulated Cell Replacement Therapy (ENCRT) device and implanted into adults with T1D. This first-in-human trial is assessing (1) safety and adverse events, (2) cell survival within the device, and (3) fibrosis, or scarring, around the implants.
Interim Results:
As planned, ENCRT devices were removed from the initial five participants after 4 months of implantation. Analysis of the removed devices show:
minimal to no fibrosis (formation of scar tissue around the device);
robust formation of blood vessels around the device;
viable islets inside the device.
These results indicate that the device has the potential to host islet cells while maintaining sufficient oxygen and nutrient flow for the cells to work effectively.
Historically, macroencapsulation devices (which act like a teabag to enclose the islet cells) have had limited success due to high levels of fibrosis that prevents cell survival, reduces the ability of the cells to access oxygen and nutrients, and limits the release of insulin. The preliminary finding that fibrosis is not occurring with Encellin’s device is therefore a critical step toward overcoming the barrier of fibrosis with islet encapsulation devices and advancing the development and delivery of cell-based therapies for people with T1D.
We will continue to report updated results as they become available.
Breakthrough T1D’s Role:
Encellin’s technology was originally developed within the Lab of Dr. Tejal Desai (University of California San Francisco) with funding from Breakthrough T1D, which was crucial in the formation of Encellin as a company and attracting subsequent venture capital.
Source: businesswire