Evaluating the safety of ENC-201-CED for Type 1 diabetes
A Safety and Tolerability Study of ENC=201-CED in Participants With Type 1 Diabetes Receiving Islet Infusion
This study is testing a new treatment called ENC-201-CED to see if it's safe for people with Type 1 diabetes when given under the skin.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Encellin Industry-sponsored |
| Locations | 2 sites (Toronto, Ontario and 1 other locations) |
| Trial ID | NCT06408311 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and tolerability of ENC-201-CED when administered in the subcutaneous space of patients with Type 1 diabetes. It involves a Phase 1 interventional approach, focusing on candidates who meet the eligibility criteria for standard of care islet infusion. The study will monitor participants for any adverse effects and overall response to the treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with Type 1 diabetes who qualify for standard of care islet infusion.
Not a fit: Patients who do not meet the eligibility criteria for standard of care islet infusion may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve glucose metabolism and overall management of Type 1 diabetes.
How similar studies have performed: There have been other studies exploring similar interventions, but the specific approach of ENC-201-CED is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Toronto, Ontario and 1 other locations
- Uhn — Toronto, Ontario, Canada (Recruiting)
- McGill University Health Centre — Montréal, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: ENC Trial Info
- Email: info@encellin.com
- Phone: 6504340987
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.