Safety of ENC-201-CED ENCRT | NCT06408311

Studies
Safety of ENC-201-CED ENCRT

NCT06408311

Sponsor

Encellin

Status

Active, not recruiting

Last Update Posted

Mar 11, 2026Actual

Enrollment

10Estimated

Phase

Phase 1

Conditions

Diabetes Mellitus, Type 1

Interventions

ENC-201-CED hPI

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2024Actual

Primary Completion Date

Jul 31, 2026Estimated

Completion Date

Oct 30, 2026Estimated

First Submitted Date

May 2, 2024

First Submission Date that Met QC Criteria

May 6, 2024

First Posted Date

May 10, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2026

Last Update Posted Date

Mar 11, 2026Actual

Name	Class
resCON Research	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ENC-201-CED hPI	Experimental		Combination Product: ENC-201-CED hPI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ENC-201-CED hPI	Combination Product	macro-encapsulated human primary islets	ENC-201-CED hPI

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Grace Wei, PhD	Encellin	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UHN		Toronto	Ontario	M5G 2C4	Canada
McGill University Health Centre

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003922	Diabetes Mellitus, Type 1
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided