Type 1 DiabetesPhase 1NCT07680673
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.
A Phase 1 study testing ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo. in people with Type 1 Diabetes, run by Encellin at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo.
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesCanada
- Study dates
- 6 Jan 2027to Jan 2029
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).
Who cannot join
- - follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites
UHN
Toronto, Ontario
Site coordinator, DDM, 416-340-4800, honey.lad@uhn.ca
Trevor Reichman, MD
Vancouver General Hospital
Vancouver, British Columbia
Michael Bleszynski, MD
About this study
Official title: Evaluation of ENCRT-103-hPI, an Immune-protected Combination Product Containing Primary Human Islets in Adults With Type 1 Diabetes, With and Without Standard-of-care Portal Vein Islet Infusion.
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.
Read the detailed description
This study is a dual-arm, three-centre, non-randomized, FIH trial that will evaluate the safety of the ENCRT-103-hPI in patients with T1D. Study subjects may be receiving standard of care islet infusion (cohort A), or not (cohort B). Cohort B will receive a different drug regimen compared to cohort A's standard of care immune management.
Both cohorts will experience equivalent processes: donor matching, comparable ENCRT-103-hPI dosages, implant into the upper arm or abdomen, explant at 4 mo and post surgical followup.
The primary objective is to evaluate the safety, tolerability, and local tissue response of fully immune-protected ENCRT devices containing primary human islets in adults with Type 1 Diabetes. Included in assessments are vascular integration and immune cell exclusion.
The secondary objectives are to evaluate of the activity, function, and survival of the donor islets from the retrieved ENCRT-103-hPI.
The exploratory objectives include measures of circulating and stimulated C-peptide, HbA1c, insulin use doses, and when available, CGM trends.
- Conditions
- Type 1 Diabetes
- Being tested
- ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo.
- Keywords
- islets, islet cell transplantation islet transplantation, Diabetes Mellitus, Diabetes Mellitus Type 1, Glucose Metabolism
- 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.
ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo.Device
Also called ENCRT, ENCRT-103, ENCRT-103-hPI, ENC-103
The ENC-103-CED is a unique device on the landscape. It is a soft, device made of non-fibrosis inducing material and design features. ENCRT-103-hPI that will be implanted consists of this device loaded with primary islets.
Both cohorts A and B will receive the intervention of an ENCRT-103-hPI implant.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: ENCRT-103-hPI with standard of care | Experimental | Patients receive standard of care islet infusion and the intervention of an ENCRT implant on the same day. Cohort A also receives standard of care drug regimen for immune management. Receives: Device: ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo. |
| Cohort B: ENCRT-103-hPI only | Experimental | Patients receive only an ENCRT implant (the intervention) and a drug for engraftment and immune management. Receives: Device: ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of device-related adverse events (AEs)
The primary objective is to evaluate the safety, tolerability, and local tissue response of fully immune-protected ENCRT devices containing primary human islets in adults with Type 1 Diabetes. Included in assessments are vascular integration and immune cell exclusion.
Measured: 4.5-5 months
Secondary outcomes (1)
Assessment of IEQ (islet equivalent) population present in explants
The secondary objectives are to evaluate of the activity, function, and survival of the donor islets from the retrieved ENCRT-103-hPI through marker expression in histological sections.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start6 Jan 2027 (estimated)
- Primary completion6 Jul 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Encellin
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680673
- Sponsor's protocol ID
- ENCRT-103-hPI
- Other IDs
- 2-IND-2026-1973-I-X
- Status last verified
- Aug 2026
- First submitted
- 24 Jun 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Participating institutions may restrict.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of ENCRT-103-hPI, an Immune-protected Combination Product Containing Primary Human Islets in Adults With Type 1 Diabetes, With and Without Standard-of-care Portal Vein Islet Infusion.
- ClinicalTrials.gov ID
- NCT07680673
- Acronym / sponsor ID
- ENCRT-103-hPI
- Conditions
- Type 1 Diabetes
- Keywords
- islets, islet cell transplantation islet transplantation, Diabetes Mellitus, Diabetes Mellitus Type 1, Glucose Metabolism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- EncellinIndustry (pharma, biotech, devices)
- Study start
- 6 Jan 2027 (estimated)
- Primary completion
- 6 Jul 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 2 Jul 2026 (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.
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.
Detailed description
This study is a dual-arm, three-centre, non-randomized, FIH trial that will evaluate the safety of the ENCRT-103-hPI in patients with T1D. Study subjects may be receiving standard of care islet infusion (cohort A), or not (cohort B). Cohort B will receive a different drug regimen compared to cohort A's standard of care immune management.
Both cohorts will experience equivalent processes: donor matching, comparable ENCRT-103-hPI dosages, implant into the upper arm or abdomen, explant at 4 mo and post surgical followup.
The primary objective is to evaluate the safety, tolerability, and local tissue response of fully immune-protected ENCRT devices containing primary human islets in adults with Type 1 Diabetes. Included in assessments are vascular integration and immune cell exclusion.
The secondary objectives are to evaluate of the activity, function, and survival of the donor islets from the retrieved ENCRT-103-hPI.
The exploratory objectives include measures of circulating and stimulated C-peptide, HbA1c, insulin use doses, and when available, CGM trends.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: ENCRT-103-hPI with standard of care | Experimental | Device: ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo.Patients receive standard of care islet infusion and the intervention of an ENCRT implant on the same day. Cohort A also receives standard of care drug regimen for immune management. |
| Cohort B: ENCRT-103-hPI only | Experimental | Device: ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo.Patients receive only an ENCRT implant (the intervention) and a drug for engraftment and immune management. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).
Key exclusion criteria (1 listed)
- - follows those of the institutions' standard of care (cohort A) or care team's guidelines (cohort B).
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 |
|---|---|---|
| ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo.Also: ENCRT, ENCRT-103, ENCRT-103-hPI, ENC-103The ENC-103-CED is a unique device on the landscape. It is a soft, device made of non-fibrosis inducing material and design features. ENCRT-103-hPI that will be implanted consists of this device loaded with primary islets. Both cohorts A and B will receive the intervention of an ENCRT-103-hPI implant. | Device | Cohort A: ENCRT-103-hPI with standard of care, Cohort B: ENCRT-103-hPI only |
Primary outcome
Rate of device-related adverse events (AEs)
Time frame: 4.5-5 months
The primary objective is to evaluate the safety, tolerability, and local tissue response of fully immune-protected ENCRT devices containing primary human islets in adults with Type 1 Diabetes. Included in assessments are vascular integration and immune cell exclusion.
1 secondary outcome
Assessment of IEQ (islet equivalent) population present in explants
Time frame: 4 months
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 20 Aug 2026.
- Individual participant dataSharing planned: Undecided. Participating institutions may restrict.
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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.
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 ENCRT-103-hPI encompasses the ENC-103 device, which will be implanted once loaded with primary islet cargo. in people with Type 1 Diabetes, 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: opening soon, as of the sponsor's last update on 20 Aug 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of device-related adverse events (AEs) (time frame: 4.5-5 months). 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 20 Aug 2026.