Safety of ENC-201-CED ENCRT

Encellin

Status and phase: Enrolling; Phase 1

Conditions: Diabetes Mellitus, Type 1

Treatments: Combination Product: ENC-201-CED hPI

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06408311

ENC201PD

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

ENC-201-CED hPI

Experimental group

Treatment:

Combination Product: ENC-201-CED hPI