Diabetes Mellitus, Type 1Phase 1NCT06408311
Safety of ENC-201-CED ENCRT
A Phase 1 study testing ENC-201-CED hPI in people with Diabetes Mellitus, Type 1, run by Encellin at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- ENC-201-CED hPI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesCanada
- Study dates
- 1 May 2024to 30 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates must satisfy site's eligibility for standard of care islet infusion.
Who cannot join
- Candidates are excluded based on the site's criteria for standard of care islet infusion.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McGill University Health Centre
Montreal, Quebec, H4A 3J1
UHN
Toronto, Ontario, M5G 2C4
About this study
Official title: A Safety and Tolerability Study of ENC=201-CED in Participants With Type 1 Diabetes Receiving Islet Infusion
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.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- ENC-201-CED hPI
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism, Islet Infusion, Pancreas Transplant
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ENC-201-CED hPICombination product
macro-encapsulated human primary islets
| Study group | Role | What they receive |
|---|---|---|
| ENC-201-CED hPI | Experimental | Not described Receives: Combination Product: ENC-201-CED hPI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Rate of device-related Adverse Events (AE)
Measured: Day 1 through Day 134
Secondary outcomes (2)
Containment
Assessment of number of islet equivalents (IEQ) in explants
Measured: post Day 120
Engraftment
Histopathology to examine degree of fibrosis (mm) from surface of CED.
Measured: post Day120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start1 May 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Encellin
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- resCON Research
- Responsible party
- Sponsor
- Investigators
- Grace Wei, PhD, Study director, Encellin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06408311
- Sponsor's protocol ID
- ENC201PD
- Status last verified
- Mar 2026
- First submitted
- 2 May 2024
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Safety and Tolerability Study of ENC=201-CED in Participants With Type 1 Diabetes Receiving Islet Infusion
- ClinicalTrials.gov ID
- NCT06408311
- Acronym / sponsor ID
- ENC201PD
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Glucose Metabolism, Islet Infusion, Pancreas Transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- EncellinIndustry (pharma, biotech, devices)
- Collaborators
- resCON Research
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ENC-201-CED hPI | Experimental | Combination Product: ENC-201-CED hPI |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Candidates must satisfy site's eligibility for standard of care islet infusion.
Key exclusion criteria (1 listed)
- Candidates are excluded based on the site's criteria for standard of care islet infusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ENC-201-CED hPImacro-encapsulated human primary islets | Combination product | ENC-201-CED hPI |
Primary outcome
Safety
Time frame: Day 1 through Day 134
Rate of device-related Adverse Events (AE)
2 secondary outcomes
Containment
Time frame: post Day 120
Engraftment
Time frame: post Day120
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grace Wei, PhD study director
Encellin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ENC-201-CED hPI in people with Diabetes Mellitus, Type 1, run by Encellin at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Day 1 through Day 134). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.