For quite a while there San Diego-based stem cell business Stemedica had a good run of publicity with reports of high-profile professional sports legends getting stem cells and the media reporting apparent good outcomes for stroke recovery, but more recent times have yielded some different publicity. An investigative report by KPBS reporter David Wagner raised some issues regarding the company. Here my take on Wagner’s report.
In his two-part piece (here and here), Wagner in part chronicled the story of stroke patient Jim Gass who ended up with a tumor on his spine after receiving several different stem cell interventions around the world over a period of years including one recently down in Tijuana administered by Dr. Cesar Amescua, who is not an employee of Stemedica.
According to Wagner’s report that last treatment involved two kinds of stem cells, one of which (adult stem cells) was reportedly manufactured by Stemedica. The other cells, fetal neural stem cells, were produced by Global Stem Cell Health. A Stemedica director was reportedly the one who referred Gass to the doctor down in Tijuana.
Many questions remain unanswered.
Where did Jim Gass’ tumor come from? Was Gass’ situation a one of a kind rare bad outcome? How many American patients have had stem cell treatments in Mexico? Barring some future new public release of genetic data on Gass’ tumor and on the various types of stem cells he received, no one will know which of the various cells and treatments he received over the years were related to that spinal tumor he later developed. However, fetal neural stem cells injected into the spine theoretically could pose a risk for development of a spinal tumor.
It is possible that administration of MSCs systematically could have contributed indirectly via immunosuppression and/or secretion of growth-promoting factors or instead they may have had nothing to do with the tumor at all. We need more data to be sure what happened here and answer these kinds of specific questions.
More broadly, after all this, where does Stemedica go from here?
Will it stay the course or change something about its practices? Could it move to focus entirely on its FDA-approved clinical trials with INDs here in the US? Will it sever the reported ties to administrations of stem cells in Mexico? What does the future hold?
I asked the company for comment on these kinds of questions about their future and while they declined to do so by email, they again invited me to come visit them and talk there. They have been very friendly with their invitations, which is appreciated. I also think it’s important to point out that Stemedica is one of the few stem cell businesses of this kind with its own high-quality cGMP facility.
It’s quite easy to determine whose cells are whose.
I’m also interesting in knowing whether the cells used for transplantation have any mutations that would increase their likelihood of forming tumors. I did offer several years ago to analyze for free the material that a patient receives as a therapy – so far no clinic has allowed the patients to keep a sample of what they are given.
“….so far no clinic has allowed the patients to keep a sample of what they are given”
Don’t you think that statement is a bit over simplistic, not to mention the fact that you seem to imply that something must be wrong since everyone doesn’t give live cell samples to their patients at your behest?
“Company X’s product might be tainted,” said competing Company Y’s VP of Propaganda. “We’ve offered to analyze their product many times to ensure its safety and so far, they’ve failed to send us a single sample,” she added with consternation.
It’s not like the patient can put a small vial of live cells in their pocket, bring them back from Mexico or China, and drop them off with your receptionist a few days later.
As you well know, transporting live stem cells properly (especially between countries) is a little more complicated (and expensive) than simply “allowing the patient to take a sample home” suggests.
And why would any stem cell lab/clinic send a sample of anything to someone openly opposed to them and actively advocating their demise anyways?
Bill Jones,
We study the cells by genomic methods so we don’t need or want live cells- we use non-viable, frozen samples. We’ve analyzed such frozen samples from around the world and developed a database of thousands of genomic profiles of stem cells, tissues, and differentiated cells, to identify unknown cell types by comparison.
In other words regardless of results cells could go on ice from any facility to Dr Loring’s facility with the permission of the patient AND the other facility. I am sure the costs of transport would not be the burden of the donating facility or the patient. This is research for safe and effective stem cells. This gives answers for not only safety but for profiles which may have promise in emergent interventions for regenerative medicine.
Dr. Loring,
Thank you for the clarification. It’s provided me, and possibly others, valuable information.
That being said, my last question remains unanswered. I could envision a clinic or lab sending samples to an impartial, independent, 3rd party lab for analysis. However, I’m skeptical that any of them would consider your lab to be impartial or you to be unbiased. That’s not meant to be an accusation.
Bill:
Just to clarify- the whole genome-based methods we use are intrinsically unbiased. It’s not possible for me to influence the results. So, my lab is about as impartial and unbiased as is possible.
Wow. A tumor of unknown origins it the worst kind of result. Did either cell type catalyze tumor stem cell activity? If I were the clinics involved, I would want to know and report.
Paul,
Your comments raise an interesting questions. Should stem cell providers maintain a repository (a couple of 100,000 cells or so) on ice (frozen) to do DNA (parent testing) of any possible tumors? Clearly, old people (and I am one of them) get tumors that may be unrelated to stem cells or not.
Certainly, the technology is well defined for parent identification and I would suspect that it can be used in the case of a discrete tumor if one had a sample from injected stem cells. While it would seem that the liability issues would discourage this, I would argue that the makers of the adult stem cells could use data from their adult cells in against any possible claims and prove it wasnt their cells (which I think existing data supports). LIkewise, with the fetal cells, assuming that the tumor arose from one of the previous stem cell injections?
And I suppose that if the tumor did arise from a US source of injected stem cells, waivers for release of liability would cover “legal issues”. On the other hand, it does gives us all a “bad hair day”.
Rick
Yes, they do make those offers all the time to speak to you in person and give you a tour of their facilities, but somehow they never actually volunteer to pay travel and lodging expenses. Given that I’m not about to pay for a plane ticket to San Diego and a night or two in a hotel there just for the honor of listening to McGuigan and Howe try to persuade me how wrong I’ve been about them and how dedicated Stemedica is to science. If they want me to listen to that pitch, they need to pay for my travel and lodging.