It’s a long way to stem cell treatment

Posted on 24. November 2009 by Vince Giuliano

If you are an old timer like me you may remember the World War I marching song: 

It’s a long way to Tipperary,

It’s a long way to go.

It’s a long way to Tipperary,

To the sweetest girl I know!

Goodbye Piccadilly, Farewell Leicester Square!

It’s a long long way to Tipperary,

But my heart’s right there.  

Last year at this time, I expected that by now, at least a Phase I clinical trial of Geron’s embryonic stem cell treatment for spinal injury would be well underway.  However, according to a Reuters press release on October 30 2009, “Geron Corporation (Nasdaq: GERN) today announced the company`s plan to advance clinical development of its human embryonic stem cell (hESC)-based product, GRNOPC1, for the treatment of spinal cord injury. The plan is expected to enable Geron to re-initiate the Phase I clinical trial of GRNOPC1 in patients with complete thoracic spinal cord injury and to support future expansion of the trial to patients with cervical injuries.” The company had plans to move the drug into Phase I clinical trials but put these on hold when preclinical trials produced cysts in some animals. “As announced previously, in one preclinical study, a higher frequency of animals developed cysts in the injury site than had been seen in numerous foregoing preclinical studies with clinical grade GRNOPC1.  These cysts are non-proliferative, confined to the injury site, smaller than the injury cavity,and were not associated with adverse effects on the animals. As part of ongoing work to optimize GRNOPC1 manufacturing and product release, the company developed new candidate markers and assays. Data from studies using the new markers were submitted to the FDA. The IND for spinal cord injury was placed on clinical hold pending FDA review of the data.”  In other words, back to the FDA drawing board for the new trial.

The news item goes on:  “Geron will complete a confirmatory preclinical study using GRNOPC1 that has been characterized by the new markers and assays, as agreed upon in discussions with the FDA. As part of the ongoing plan to advance clinical development to cervical patients, Geron had already initiated this preclinical study in an animal model of cervical injury. — In discussions with the company, the FDA has advised that it concurs with Geron that positive data from this study can be used to support both release of the clinical hold and expansion to cervical patients. Geron expects the data from this study to enable re-initiation of the clinical trial in the third quarter of 2010.” 

So the good news is that when, assuming there is a when a year or more from now, GRNOPC1 goes into human clinical trial it can possibly be for both thorasic and cervical spinal cord injuries.  In the meantime, there is yet-another preclinical study.  Learning about this 18 month delay, I composed this version of the Tipperary song:

It's a long way to stem cell treatment, 

It's a long way to go! 
It's a long way to stem cell treatment,
To the sweetest treatment we’ll  ever know!
Goodbye radiation, Farewell scalpel and chemo! 
It's a long long way to stem cell treatment, 
But my heart's with the new techno.  
 

About Vince Giuliano

Being a follower, connoisseur, and interpreter of longevity research is my latest career, since 2007. I believe I am unique among the researchers and writers in the aging sciences community in one critical respect. That is, I personally practice the anti-aging interventions that I preach and that has kept me healthy, young, active and highly involved at my age, now 93. I am as productive as I was at age 45. I don’t know of anybody else active in that community in my age bracket. In particular, I have focused on the importance of controlling chronic inflammation for healthy aging, and have written a number of articles on that subject in this blog. In 2014, I created a dietary supplement to further this objective. In 2019, two family colleagues and I started up Synergy Bioherbals, a dietary supplement company that is now selling this product. In earlier reincarnations of my career. I was Founding Dean of a graduate school and a full University Professor at the State University of New York, a senior consultant working in a variety of fields at Arthur D. Little, Inc., Chief Scientist and C00 of Mirror Systems, a software company, and an international Internet consultant. I got off the ground with one of the earliest PhD's from Harvard in a field later to become known as computer science. Because there was no academic field of computer science at the time, to get through I had to qualify myself in hard sciences, so my studies focused heavily on quantum physics. In various ways I contributed to the Computer Revolution starting in the 1950s and the Internet Revolution starting in the late 1980s. I am now engaged in doing the same for The Longevity Revolution. I have published something like 200 books and papers as well as over 430 substantive.entries in this blog, and have enjoyed various periods of notoriety. If you do a Google search on Vincent E. Giuliano, most if not all of the entries on the first few pages that come up will be ones relating to me. I have a general writings site at www.vincegiuliano.com and an extensive site of my art at www.giulianoart.com. Please note that I have recently changed my mailbox to vegiuliano@agingsciences.com.
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