A Bioassay for Diabetes

The content for this column is provided by the Iacocca Foundation

Helping to Advance Research

May 1, 2005

In 2001, researchers led by Denise Faustman, MD, PhD, at Massachusetts General Hospital (MGH) reversed and cured type 1 diabetes in mice. The development and refinement of a bioassay is part of their ongoing research to bring these findings to human trials. Their first human trial, an FDA-approved trial using a bacillus Calmette-Guerin (BCG) vaccine, is expected to start later this year once sufficient funding has been raised.

What Is a Bioassay?

A bioassay is a blood-based test. The bioassay being developed by the Faustman lab will, hopefully, allow the researchers to measure the concentration of diseased cells in blood samples from type 1 diabetics; measure T cell levels to evaluate how well any tested therapies work; and determine the most optimal times and doses to administer the tested therapies.

Not only will the bioassay provide the researchers with useful information, it will also automate a process of blood testing that has been done by hand (taking up to one and a half days to complete each individual blood sample), thus speeding up the process significantly.

The Importance of This Blood Test

Developing a human cell-based assay for autoimmunity has never been done before. This technology will be extremely important for the human trials. For example, if someone discovered insulin but did not have a way of checking blood glucose levels, what would be the chance a trial testing insulin could uncover the correct, beneficial dosing of insulin? This is the concept of the human cell-based assay for autoimmunity— the researchers need to know how much of a drug to use to produce a response.

In the first human trial, they will need to measure the pathogenic (disease-causing) T cells to see if BCG is eliminating them. If they are being eliminated, they need to know what the best dosing of the drug is. If they cannot measure these T cells, there is a reduced chance they can achieve correct BCG dosing. The successful development of a bioassay will allow researchers to conduct the first phase 1 trial and then move to later-stage clinical testing as quickly and cost-effectively as possible.

How Can I help?

The first three years of this program—including refinement of the experimental therapy, technology development and the first phase 1 clinical trial—will cost an estimated $11 million. Contribute to Join Lee Now and support these efforts to cure type 1 diabetes in humans.

Donations may be made over the Internet or by mail.

To make a donation over the Internet, please visit www.JoinLeeNow.org and click on “Donate Now.”

U.S. mail:
To mail your donation, please make checks payable to “Iacocca Foundation.” Please write “Join Lee Now” in the subject line. All donations can be sent to the following address:

The Iacocca Foundation
17 Arlington Street
Boston, MA 02116

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