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JDRF Funded Research

JDRF-Funded Research:  Lay Abstract

Name:   Mark Atkinson ,Ph.D.
University of Florida, USA
Lab Website:  

Project duration:   01-SEP-2012   to   28-FEB-2014
Strategic Research Agreement

Project grant award:   $118,932.00*

* Total Grant award amount may vary depending on budget adjustments and it is contingent upon research progress and availability of JDRF research funds.
File No:   17-2012-541

(Abstract Dt: 01-SEP-2012)

Therapeutic Area:   Immune Therapies

Grant Status: Active
Project Title
Ex Vivo Analysis of the Cell Educator System
Objective
Seek independent validation of early key issues with Cell Educator therapy as follows: "What changes does Cell Educator Therapy impart on leukocytes?" "Are the observed effects with Cell Educator Therapy specific or unique to patients with T1D (versus healthy controls)?" "Does allogeneic human cord blood provide specific (and beneficial) properties in the Cell Educator?"
Background/Rationale
The findings from the Cell Educator clinical trial not only demonstrated the feasibility and safety of this form of therapy but quite remarkably, noted that T1D patients achieve improved metabolic control that (thus far) has lasted for many months following a single treatment. Notably, this trial provided intriguing evidence that the treatment may lead to either regeneration of islet ß cells, or a restoration of existing ß cells to produce insulin; this, based on elevations (post-therapy) in Cpeptide production. Taken collectively, this study demonstrated the safety and therapeutic efficacy of Cell Educator therapy in Chinese T1D patients.
Description of Project
In terms of T1D, cord blood derived cells have been noted for their ability to alter the pathogenesis of T1D in the NOD mouse model of the disease. Based on these findings, an investigator of this SRA (Zhao) developed the novel Cell Educator therapy as a means for intervening in patients with T1D. With this procedure, a patient's blood is "educated" by cord blood stem cells ex vivo. The findings from the Cell Educator clinical trial not only demonstrated the feasibility and safety of this form of therapy but quite remarkably, noted that T1D patients achieve improved metabolic control that (thus far) has lasted for many months following a single treatment. Notably, this trial provided intriguing evidence that the treatment may lead to either regeneration of islet ß cells, ora restoration of existing ß cells to produce insulin; this, based on elevations (post-therapy) in Cpeptide production. Taken collectively, this study demonstrated the safety and therapeutic efficacy of Cell Educator therapy in Chinese T1D patients. With any "breakthrough" discovery, an important follow-up phase is one involving independent scientific validation. This is the purpose of this SRA; through collaboration with the inventor of this technology, seek independent validation of early key issues.
Anticipated Outcome
To determine 1) if, and 2) how a potential cord blood educator therapy clinical trial would be devised. This would, again, rest on a series of observations including not only this proposed validation study, but other observations within the field (e.g., results of additional/ongoing Chinese cell educator trials).
Relevance to Type I Diabetes
We posit the program to represent an effective "first step" to utilize cord blood therapies for persons with T1D and potentially, for those at increased risk for the disease.