Allogenic Islet Cell Transplantation for Diabetes, Autoimmune

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Diabetes, Autoimmune+1 More
Allogenic Islet Cell Transplantation - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether islet transplantation is safe and can better control blood sugar than state-of-the-art insulin treatment in people with type 1 diabetes who have had severe hypoglycemic episodes.

Eligible Conditions
  • Diabetes, Autoimmune

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: within 1 year of transplant

Year 1
Incidence of procedure related adverse events
Insulin independence achieved
Proportion of subjects free of severe hypoglycemic events between 6 and 12 months from the time of first islet cell infusion or from the time insulin therapy is withdrawn
Proportion of subjects with HbA1c less than or equal to 7.0%

Trial Safety

Trial Design

1 Treatment Group

Allogenic Islet Cell Transplantation
1 of 1
Experimental Treatment

10 Total Participants · 1 Treatment Group

Primary Treatment: Allogenic Islet Cell Transplantation · No Placebo Group · Phase 1 & 2

Allogenic Islet Cell Transplantation
Biological
Experimental Group · 1 Intervention: Allogenic Islet Cell Transplantation · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: within 1 year of transplant

Who is running the clinical trial?

Kenneth Brayman, MDLead Sponsor

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a reduced awareness of hypoglycemia.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 22nd, 2021

Last Reviewed: October 27th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

What state do they live in?
Ohio100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Virginia100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%