Intraportal infusion of islet cells for Type 1 Diabetes

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Chicago Medical Center, Chicago, ILType 1 DiabetesIntraportal infusion of islet cells - Procedure
Eligibility
18 - 70
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether islet transplantation is safe for people with Type 1 diabetes. Islets are clusters of cells that produce insulin, and the trial will use islets from cadaver donors.

Eligible Conditions
  • Type 1 Diabetes

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 1 year

1 year
HbAlc <7.0% and an absence of severe hypoglycemic events

Trial Safety

Trial Design

1 Treatment Group

Allogenic islet cells (human, U. Chicago)
1 of 1

Experimental Treatment

20 Total Participants · 1 Treatment Group

Primary Treatment: Intraportal infusion of islet cells · No Placebo Group · N/A

Allogenic islet cells (human, U. Chicago)Experimental Group · 2 Interventions: Allogenic islet cells (human, U. Chicago), Intraportal infusion of islet cells · Intervention Types: Biological, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intraportal infusion of islet cells
2008
Completed Phase 2
~10

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

University of ChicagoLead Sponsor
937 Previous Clinical Trials
754,314 Total Patients Enrolled
Piotr Witkowski, MD, PhDPrincipal InvestigatorUniversity of Chicago
1 Previous Clinical Trials
13 Total Patients Enrolled

Eligibility Criteria

Age 18 - 70 · All Participants · 5 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
New York33.3%
Arkansas33.3%
Washington33.3%
How old are they?
18 - 65100.0%
What site did they apply to?
University of Chicago Medical Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

Frequently Asked Questions

Are the criteria for this medical trial compatible with my health profile?

"The clinical trial is presently recruiting 20 participants aged 18-70 who suffer from diabetes and other autoimmune diseases. In order to be eligible, male or female patients must provide written informed consent and demonstrate an age plus duration of insulin dependent diabetes duration of 28 or more; have experienced at least one episode of severe hypoglycemia within the past year; partake in intensive glucose management under a medical professional's direction with 3+ evaluations yearly; display reduced awareness/fear of hypoglycemia as proven by Clarke score >4 or HYPO Score >90th percentile (1047) during screening period & last 6 months OR LI score >90" - Anonymous Online Contributor

Unverified Answer

How many participants is this study accepting for its research?

"Yes, the clinicaltrials.gov website has updated information about this current trial that began on May 1st 2012 and was last revised December 22nd 2020. The research is looking to recruit 20 people from a single location." - Anonymous Online Contributor

Unverified Answer

Is this clinical trial open to individuals younger than 85 years?

"For inclusion in this study, participants must be 18 years of age or older and no more than 70 years old." - Anonymous Online Contributor

Unverified Answer

Are there remaining vacancies in this research project?

"Affirmative. Data hosted on clinicaltrials.gov validates that this medical study, which was originally posted on May 1st 2012, is actively recruiting for candidates. 20 participants need to be enrolled from a single place of care." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.