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A Comparison of Islet Cell Transplantation With Medical Therapy for the Treatment of Diabetic Eye Disease

NCT00853424 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2014-03-17

No results posted yet for this study

Summary

Diabetic eye disease remains a major cause of visual loss for individuals with type 1 diabetes, despite currently available treatments. Preliminary studies indicate that islet cell transplantation, a new treatment for type 1 diabetes, may be beneficial for some people. This study is designed to test the hypothesis that islet cell transplantation is more effective than current medical therapy in preventing the progression of diabetic eye disease.

Conditions

Interventions

PROCEDURE

islet cell transplant

Human pancreases are retrieved from multiorgan donors and processed with intraductal collagenase perfusion, continuous digestion, and density gradient purification with impure tissue fractions cultured in vitro and then repurified to retrieve additional islets. Islets are implanted by ultrasound guided percutaneous portal embolization, to provide more than 12, 000 islet equivalents (IE) per kilogram of body weight (infusions from 1-3 donors per patient) Immunosuppression consists of antithymocyte globulin, basiliximab, mycophenolate mofetil and tacrolimus as described (Warnock et al Arch Surg 2005;140:735).

OTHER

Medical therapy

subjects receive all recommended medical treatment for diabetes and diabetic eye disease

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • David M. Thompson, MD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-12-31
Completion
2010-12-31

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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 NCT00853424 on ClinicalTrials.gov