Treatment for Diabetes type1

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Alberta Hospital, Edmonton, Canada
Diabetes type1+1 More
cePolytreg - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

The transplant of the insulin-producing cell into the liver (Islet transplant) has been proven an effective and valuable treatment for type 1 diabetics patients with poor blood sugar. However, Islet transplant is currently limited by the number of pancreas organ donors and the need for lifelong medication requirements such as antirejection drugs. The investigators have learned that Regulatory T cells (Tregs), a small subset of a cluster of differentiation 4+ (CD4+) T cells, have emerged as the major contributor to self-tolerance by preventing the initiation of unwanted immune activation and by suppressing ongoing immune responses to limit bystander tissue destruction. It has been suggested that infusion of Tregs before extensive graft damage may improve long-term graft outcomes. In this trial, we propose to study Analogous cryopreserved PolyTregs (cePolyTregs). cePolyTregs is a product with the same in vivo functionality to that of the non-cryopreserved PolyTregs.

Eligible Conditions

  • Diabetes type1

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 58 weeks

58 weeks
Adverse Events
Week 58
Stimulated C-peptide level

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Control
1 of 2
Treatment
1 of 2
Active Control
Experimental Treatment

11 Total Participants · 2 Treatment Groups

Primary Treatment: Treatment · No Placebo Group · Phase 1

Treatment
Biological
Experimental Group · 1 Intervention: cePolytreg · Intervention Types: Biological
ControlNoIntervention Group · 1 Intervention: Control · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 58 weeks
Closest Location: University of Alberta Hospital · Edmonton, Canada
Photo of university of alberta hospital  1Photo of university of alberta hospital  2Photo of university of alberta hospital  3
2009First Recorded Clinical Trial
1 TrialsResearching Diabetes type1
275 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have reduced awareness of hypoglycemia, as defined by the absence of adequate autonomic symptoms at plasma glucose levels < 3.
You have diabetes mellitus type 1 or type 2 and you have a ketoacidosis that lasts more than 24 hours.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 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.