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NCT07680673
ENCRT-103-hPI: Evaluation of an Immune-protected ENCRT-103-hPI Containing Primary Human Islets in Adults With Type 1 Diabetes, With and Without Standard-of-care Portal Vein Islet Infusion.
Conditions: Type 1 Diabetes
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 10
Sponsor: Encellin
Location: Vancouver General Hospital Vancouver British Columbia
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.
Eligibility Criteria
Inclusion Criteria:
* follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).
Exclusion Criteria:
* \- follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).
Source: ClinicalTrials.gov (NCT07680673). StuddyBuddy aggregates publicly available trial information.