Safety of ENC-201-CED ENCRT

A Safety and Tolerability Study of ENC=201-CED in Participants With Type 1 Diabetes Receiving Islet Infusion

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06408311

Enrollment

Registered

2024-05-10

Start date

2024-05-01

Completion date

2026-10-30

Last updated

2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism, Islet Infusion, Pancreas Transplant

Brief summary

The purpose of the study is to evaluate the safety and tolerability of ENC-201-CED in a subcutaneous space in patients with Type I diabetes.

Interventions

COMBINATION_PRODUCTENC-201-CED hPI

macro-encapsulated human primary islets

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Candidates must satisfy site's eligibility for standard of care islet infusion.

Exclusion criteria

* Candidates are excluded based on the site's criteria for standard of care islet infusion.

Design outcomes

Primary

Measure	Time frame	Description
Safety	Day 1 through Day 134	Rate of device-related Adverse Events (AE)

Secondary

Measure	Time frame	Description
Containment	post Day 120	Assessment of number of islet equivalents (IEQ) in explants
Engraftment	post Day120	Histopathology to examine degree of fibrosis (mm) from surface of CED.

Countries

Canada

Contacts

STUDY_DIRECTORGrace Wei, PhD

Encellin

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026