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.

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