Clinical Research Directory
Browse clinical research sites, groups, and studies.
The Purpose of the Study is to Evaluate the Safety and Performance of ENCRT-103-hPI in Patients With Type I Diabetes. ENCRT-103-hPI is an Implantable Product Shielding Primary Islets From the Immune System.
Sponsor: Encellin
Summary
This study will evaluate the safety and performance of ENCRT-103-hPI, which is a cargo of primary islets inside Encellin's ENC-103-CED. The 103 offers a soft pillow-like encasing to contain and protect the cells from the immune system. The product is implanted in the upper arm or abdomen and is approximately the size of a quarter. Eligibility is open to both patients on a standard of care islet infusion wait list, as well as those who are not. Participation in this trial does not preclude future Encellin trial participation. The study duration is 4.5months and requires keeping the implant for 4 months, as well as adhering to a standard of care schedule of follow ups during the implant period.
Official title: Evaluation of ENCRT-103-hPI, an Immune-protected Combination Product Containing Primary Human Islets in Adults With Type 1 Diabetes, With and Without Standard-of-care Portal Vein Islet Infusion.
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2027-01-06
Completion Date
2029-01
Last Updated
2026-07-02
Healthy Volunteers
No
Conditions
Interventions
ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo.
The ENC-103-CED is a unique device on the landscape. It is a soft, device made of non-fibrosis inducing material and design features. ENCRT-103-hPI that will be implanted consists of this device loaded with primary islets. Both cohorts A and B will receive the intervention of an ENCRT-103-hPI implant.
Locations (3)
Vancouver General Hospital
Vancouver, British Columbia, Canada
UHN
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada