Islet Transplantation for Patients With Type 1 Diabetes

Islet Transplantation for Patients With Type 1 Diabetes and Stable Renal Allografts Using Steroid Sparing Immunosuppression

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00073281

Enrollment

Registered

2003-11-20

Start date

2003-08-31

Completion date

2004-12-31

Last updated

2010-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

diabetes, autoimmunity

Brief summary

This protocol will test whether Type 1 diabetes (T1DM) can be reversed in patients with stable renal allografts by islet transplantation.

Detailed description

We will test whether pancreatic islets isolated from cadaveric human donor pancreata can be transplanted into the portal vein of patients with T1DM who have stable renal allografts to achieve insulin independence for the recipient. The protocol will employ a defined islet isolation procedure, percutaneous islet infusion into the recipient's portal vein via an intra-portal catheter, tight glycemic control during the peri-transplant period, and an immunosuppressive protocol that avoids glucocorticoids.

Interventions

PROCEDUREIslet transplantation

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Patients with type 1 diabetes with stable renal allografts

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026