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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 134
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if ENC-201-CED is safe and well-tolerated when injected under the skin of patients with Type I diabetes.
Who is the study for?
This trial is for individuals with Type 1 Diabetes who meet the criteria for standard islet cell infusion therapy. It's not open to those who don't qualify for this standard treatment according to the site's specific rules.
What is being tested?
The study tests ENC-201-CED, a new intervention administered under the skin, to check its safety and how well patients can tolerate it in managing Type 1 Diabetes.
What are the potential side effects?
Since this trial aims to assess safety, potential side effects are being studied. However, common side effects may include reactions at the injection site or other systemic responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 through day 134
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 134
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety
Secondary study objectives
Containment
Engraftment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: ENC-201-CED hPIExperimental Treatment1 Intervention
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Who is running the clinical trial?
EncellinLead Sponsor
resCON ResearchUNKNOWN
Grace Wei, PhDStudy DirectorEncellin
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