Long Term Follow up of Recipients of Functional Islet Allografts

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Long Term Follow up of Recipients of Functional Islet Allografts

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01999374
• Other study ID #: 20130034
• Status: Recruiting
• Start date: March 2013
• Est. completion date: December 2027

Study information

• Verified date: January 2024
• Source: University of Miami
• Contact: David A Baidal, MD
• Phone: 305 243-7740
• Email: dbaidal[@]med.miami.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Since its inception, the Diabetes Research Institute (DRI) has made significant contributions to the field of diabetes, pioneering many of the techniques used in diabetes centers around the world. Through several clinical trials, DRI has demonstrated that diabetes can be successfully reversed as a result of islet cell transplant.

Over the years the following protocols in islet cell transplantation have been initiated:

2000/0329; 2000/0196; 2004/0205; 2000/024; 2006/0200; 2006/0508; 2006/0210.

All of the studies listed above will be source of study subjects for this study. Approximately 30 subjects are expected to be enrolled and followed in this trial.

After islet-cell transplantation in the parent studies, each subject receives maintenance immunosuppressive medications.

The purpose of this protocol is to collect additional follow-up for safety and efficacy from subjects with graft function after their completion in their parent study. It is expected that most subjects will retain measurable islet function and, in the islet-alone studies, continue to receive immunosuppressive medications at the time of completing their parent study.

Description:

To provide long term follow up in subjects with functional islet allografts.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2027
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Participation in any of the following parent studies: 2000/0329; 2000/0196; 2004/0205; 2000/0024; 2006/0200; 2006/0508; 2006/0210

2. A functioning pancreatic islet graft (absence of graft failure as defined in parent study) requiring immunosuppression.

3. Willingness of participants to continue to use an approved method of contraception during and 4 months after study participation.

4. Ability to provide written informed consent.

Exclusion Criteria:

1. For female subjects: Positive pregnancy test, presently breast-feeding, or unwillingness to use effective contraceptive measures for the duration of the study and 4 months after discontinuation. For male subjects: intent to procreate during the duration of the study or within 4 months after discontinuation or unwillingness to use effective measures of contraception. Oral contraceptives, Norplant®, Depo-Provera®, and barrier devices with spermicide are acceptable contraceptive methods; condoms used alone are not acceptable.

2. Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Locations

Country	Name	City	State
United States	Diabetes Research Institute	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Rodolfo Alejandro

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of sustained islet allograft function	The primary endpoint is duration of sustained islet allograft function as determined by evidence from Mixed Meal Tolerance Test of c-peptide production. A c-peptide level >=0.3 ng/ml at 0, 60, or 90 minutes will be considered evidence of islet allograft function.	3 years