Who ever knew that a horse named Jim would change the face of medicine?
True story. Back in 1901 a serious diphtheria epidemic was sweeping through St. Louis. Back then doctors used antitoxins prepared in horses to treat people with diphtheria. Unfortunately unbeknown to the doctors, Jim, one of the horses they used to create these antitoxins had contracted tetanus. The antitoxins prepared in Jim then spread that tetanus to patients and 13 children died.
As a result of all that Congress passed the Biologics Control Act of 1902 to regulate the manufacture of vaccines and antitoxins. In future all those involved in creating these life-saving medications had to show they had Good Manufacturing Practices or GMP.
Today GMP has become a byword, or at least a by-acronym, for ensuring that therapies designed to promote health and fight disease don’t have the opposite effect.
So what does that have to do with the stem cell agency? For the answer you just have to take a tour of the GMP facility at Dr. Jan Nolta’s Stem Cell Program at the UC Davis Institute for Regenerative Cures. The facility was created by Gerhard Bauer, who is something of an engineering genius.
Here’s our video about that facility:
Dr. Nolta’s team is working hard trying to find stem cell therapies for a number of nasty neurological disorders such as Huntington’s disease. An essential element in that work is having a consistent supply of high quality stem cells that meet rigorous scientific standards – namely that they are all the same stem cell line, all consistently produce the same therapeutic effect and are not contaminated in any way.
That’s where Gerhard comes in. CIRM funds have helped him create a state-of-the-art GMP facility that is so sophisticated and advanced it has raised the bar on what a GMP facility should be.
The importance of this particular facility is not just that it can produce high quality stem cells for laboratory research, but as soon as research identifies promising candidate therapies based on these stem cells it can produce those therapies for use in clinical trials immediately. And of course if those therapies ultimately prove to be effective, Gerhard’s GMP facility can then produce them for use in patients – and not just at UC Davis but potentially anywhere they are needed.
In effect the stem cell agency is helping fund a pipeline that takes research from the lab, through clinical trials, and directly to people.
We’ve come a long way since the days of Jim when therapies were incubated in horses. Clearly we still have a long way to go before we have effective therapies for so many deadly diseases and disorders. But when you see first hand the skill, ingenuity, dedication and passion that people like Gerhard Bauer and Dr. Nolta bring to their work every day, it’s hard to have any doubts that the pipeline we have helped create is going to produce therapies that have the potential to help so many people in need.