One of our latest reports, “Type 1 Human Clinical Trials That Target a Practical Cure”, evaluated the research designs of projects in type 1 clinical trials to determine if any aim to deliver a result that could satisfy the JDCA’s definition of a Practical Cure. The results were eye opening- only 5 projects had the possibility of delivering a cure-like lifestyle for people with established type 1 diabetes.
Shortly after this report was sent to the printer, news broke about a new stem cell treatment, The Stem Cell Educator, that could hold the key to a type 1 cure. The Stem Cell Educator, led by Dr. Yong Zhao, an assistant professor in the section of endocrinology, diabetes and metabolism at the University of Illinois at Chicago, just completed phase one clinical trials.
We received questions via email and on Facebook, so we had our Director of Research Analysis review the project design to determine if it could achieve a Practical Cure.
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Dr. Zhao’s Phase 1 study using the Stem Cell Educator takes a novel approach to curing type 1 and some interesting results were demonstrated. Although the initial Phase 1 results appear promising, we do not believe that this treatment qualifies as a potential Practical Cure.
It is encouraging that the study involved individuals with established type 1 in either moderate or severe form, with a median period of 8 years after diagnosis. It is also encouraging that this phase 1 trial that primarily focused on safety also demonstrated some efficacy. The results showed reduced insulin requirements over the measurement periods, improved C-peptide levels, and lower A1c readings. That’s all good. However, when evaluating a treatment as a potential Practical Cure we consider the treatment’s design and what it is intending to accomplish.
We believe that the “Stem Cell Educator” only targets a portion of a potential Practical Cure. Autoimmunity is directly addressed and this is where the treatment seems to be effective. The cells that are treated by the stem cell educator and then returned to an individual seem to stop or lessen the autoimmune response. With a diminished autoimmune attack, beta cells are permitted to regenerate naturally.
Research studies have already determined that established diabetics can naturally regenerate beta cells.
However, after new beta cells are manufactured, the autoimmune attack subsequently destroys them. If autoimmunity is stopped or impeded, then the effects from natural beta cell regeneration might be seen. That appears to us what is being demonstrated in this study and is resulting in reduced insulin requirements and improved C-peptide levels.
No artificial beta cell regeneration agents are introduced to stimulate beta cell regeneration as part of this treatment. Therefore, it seems that any endogenous insulin production may be due to natural beta cell re-growth. However, no studies have demonstrated that natural beta cell regeneration alone is sufficient to eliminate the need for exogenous insulin for established diabetics.
We believe the “Stem Cell Educator” potentially could be part of a Practical Cure. It might need to be combined with an agent to regenerate beta cells or with a beta cell mass that can survive and deliver the efficacy that is required by a Practical Cure and be developed and approved by 2025. As a standalone treatment, however, it is not a potential Practical Cure, in our view.
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It is important to keep in mind that the JDCA is not judging the success of any projects. We are not scientists- we evaluate what the project is working to achieve. Moreover, projects that do not meet our definition of a Practical Cure could be part of a future treatment therapy. Our definition of a Practical Cure focuses research on the end result that people with type 1 and their families would consider a cure-like lifestyle. We want to see this result delivered to people now living with the disease.
Cara
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