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Islet Cell Transplantation Alone and CD34+ Enriched Bone Marrow Cell Infusion in Patients With Diabetes Mellitus: Steroid-Free Regimen

NCT00021801 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2010-03-02

No results posted yet for this study

Summary

The goal of islet cell transplantation in Type 1 diabetics is to provide those affected with constant normal blood glucose levels, thereby reducing or eliminating altogether the need for injected insulin. This normalization may prevent or slow progression of diabetic complications, result in a healthier lifestyle, and lead to a better quality of life.

Participants who meet the inclusion criteria will undergo an extensive screening process which typically includes a series of blood tests, EKG, chest x-rays, and a psychological evaluation, among others. Those who are eligible for and chose to participate in the trial will receive an islet cell transplant and bone marrow infusion from the same donor, together with following immunosuppressive medications: tacrolimus, sirolimus, daclizumab and infliximab. Because the bone marrow infusion may successfully prevent the transplanted islet cells from rejecting, some participants may be able to stop taking the immunosuppressive medications after a year.

The islet cell transplant is done under local anesthesia in a special procedure radiology room. Several days after the islet cell transplant, the participant is admitted to the hospital as an outpatient in order to receive bone marrow via a simple intra-venous infusion procedure.

All participants will need to be seen at the Diabetes Research Institute after the transplant for follow-up testing and post-islet cell transplant care.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

PROCEDURE

Islet Cell Transplantation

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Rodolfo Alejandro, MD · University of Miami Diabetes Research Institute

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-03-31
Completion
2000-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00021801 on ClinicalTrials.gov