12 People Hospitalized With Infections From Stem Cell Injections in the USA


How to protect yourself and your loved ones

On December 20, 2018, the New York Times issued an article on the cases of 12 people who got seriously ill following stem cell injections. “The people who became ill after receiving the Genetech (Ed: the Californian company responsible for the contaminated blood products) products had been given injections into their knees, shoulders or spines to treat painful conditions like arthritis or injuries. They contracted infections in their bloodstreams or joints, and all were hospitalized.”

As reported by the Times, the victims received contaminated products – some products were even contaminated by fecal matter. Two main issues are highlighted by this very serious, dangerous and preoccupying situation: the offering of fee-for-service unproven “stem cells therapies” and the administration of contaminated products.

Quality manufacturing of cell therapy products is of outmost importance. Our mission at CellCAN is to improve the quality, safety and feasibility of cell and gene therapy in Canada through optimal manufacturing practices. We believe that cell and gene therapy manufacturing in Canada should operate under a common seal of quality to increase capacity and rapidly and effectively migrate innovative treatment concepts into standard clinical practice.

Although this happened in the United States, Canadians are also at risk to be victims of similar scams due to fee-for-service clinics operating outside of the regulations. Authorities like, Health Canada, are aware of the situation and CellCAN is collaborating on the current regulatory reform to protect the health and safety of Canadians. Cell and gene therapy is an emerging, rapidly evolving field and regulatory reform is underway to design a new regulatory framework that is better suited to this new reality. Many clinics offering fee-for-service stem cell therapies use autologous therapies that they claim are for homologous use (aka reinjecting one’s own cells into the body for the same purpose/function) and claim that they are minimally manipulated so they do not fall under some of the existing regulations. They rather claim these therapies fall under medical practice. Unfortunately, these perceived “loopholes” are actually false and represent inaccurate interpretation of the current regulations. This thus explains why the administration of contaminated products could occur for unproven therapies that are being offered even here in Canada.

A study published in September 2018 by Leigh Turner paints a picture of the Canadian landscape of the direct-to-consumer marketing of stem cell interventions by Canadian businesses (see full article here). The study found that 30 Canadian businesses were offering stem cell-based therapies at 43 clinics. Rather than focusing on scientific evidence to promote their treatment, clinics use marketing techniques and prey on the hope of patients willing to pay out-of-pocket money to receive a treatment that has not proven its safety nor its efficacy. That also means the cellular products that are administered could have been manufactured in less than ideal manufacturing conditions, proving to be a liability for the patient.

The tricky part in all of this is that although stem cell therapies and regenerative medicine are very promising, most advances are still at the research stage – it’s an exercise of patience for thousands of patients who know we are just on the verge of having a treatment that could improve their daily quality of life (for arthritis for instance). Going through all the requirements to offer a proven therapy is a lengthy, rigorous process but one that is necessary to ensure the safety of patients.

As a knowledge mobilization network funded by the federal government, it is critical to us at CellCAN to provide reliable and comprehensible information to patients and the general public so that they can remain safe and healthy. We have developed a series of information flyers that is available for free on our website. ‘’From microscope to stethoscope’’ explains the steps to developing a novel therapy and details the importance of the process and why it matters that these steps are followed. We have also developed a pamphlet on the “Potential dangers of medical tourism” which is also now in our backyard. We understand that some patients can be tempted to try anything when they feel like they have no other option. However, this could have serious consequences and even worsen their condition (as sadly demonstrated in the NYT article and another recent article of three patients going blind after receiving stem cell injections). We provide patients with a list of facts to be aware of and the key elements they should be looking out for before receiving ANY therapy, whether abroad or here in Canada.

Ultimately, your primary caregiver, your physician, should be able to give you a complete outlook on the therapies available to you for your condition. If you find a clinic that offers a therapy for your condition, discuss it with your doctor who will be able to help you distinguish a legitimate clinic from one making fraudulent claims. Your doctor could also direct you towards a legitimate clinical trial, which is an experimental treatment, but that undergoes rigorous regulatory oversight and review by authorities such as Health Canada.

You should always consult with your doctor before making any decision about your health. Remain assured that the authorities are working on this issue and that the health and safety of Canadians is the utmost priority for all those working in the ‘’legitimate’’ path to developing new therapies. As such, the US FDA has conducted a crackdown on fraudulent clinics in the past year and it is expected that more of these clinics will be shut down in the near future.

Finally, safety should always be the primary focus for any level of cell manipulation, and CellCAN will continue to develop proactive initiatives with Health Canada, to ensure that actions are being taken before any adverse reactions are being reported in Canada.

More resources
If you are looking for information on cell and gene therapies and more broadly about the therapies available for your condition, patient advocacy groups and foundations typically have reliable information on their websites. You can also consult CellCAN’s website and information flyers or contact us on our Helpdesk if you have specific questions.

  • 21/12/2018

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