Islet Cell Transplantation Alone in Patients With Type 1 Diabetes Mellitus: Steroid-Free Immunosuppression

Summary

SPECIFIC AIMS:

1. To reverse hyperglycemia and insulin dependency in patients with Type 1 Diabetes Mellitus by islet cell transplantation;
2. To eliminate the incidence of hypoglycemia coma and unawareness in patients with Type 1 Diabetes Mellitus by islet cell transplantation;
3. To assess long-term safety and function of successful islet cell transplants in patients with Type 1 Diabetes Mellitus;
4. To determine whether the natural history of the microvascular, macrovascular and neuropathic complications of Diabetes Mellitus are altered following successful transplantation of islet cells; and
5. To assess the effect of infliximab in preventing early islet destruction, and thereby eliminating the need for a second donor's islet cells.
6. To assess the effect of etanercept in preventing early islet destruction.
7. To assess the effect of exenatide to improve islet graft function and survival in subjects that have returned to using exogenous insulin.
8. To assess the ability of exenatide to improve islet survival at time of transplantation.

Conditions

• Diabetes Mellitus, Type I

Interventions

DRUG

islets

Intraportal infusion of islets

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• Health Resources and Services Administration (HRSA)

  collaborator FED

• Diabetes Research Institute Foundation

  collaborator OTHER

• University of Miami

  collaborator OTHER

• National Center for Research Resources (NCRR)

  collaborator NIH

• Rodolfo Alejandro

  lead OTHER

Principal Investigators

• Rodolfo Alejandro, M.D. · University of Miami, Diabetes Research Institute

• Camillo Ricordi, M.D. · University of Miami, Diabetes Research Institute

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2000-12-31

Primary Completion

2004-07-04

Completion

2004-07-04

FDA Drug

Yes

Countries

• United States

Study Locations