Recently we wrote about a workshop on unproven stem cells treatments that featured Prof. Timothy Caulfield, a member of our Foundation’s Science Leadership Council. Unproven stem cells treatments are scientifically untested, lack regulatory or ethics approval and may lead to serious health consequences.
In order to increase public awareness, the University of Alberta’s Prof. Caulfield and Dr. Zubin Master of Albany Medical College, have developed a booklet called “What you need to know about stem cell therapies.”
The booklet, sponsored by Stem Cell Network, can be found here.
“Most stem cell therapies are still considered research and are a long way from the clinic,” write the authors.
The process of translation from scientific knowledge to the approval of a treatment, or clinical translation, takes several steps. It starts with preclinical research, with scientists using stem cells on animals to show that the treatment is safe and effective.
After a review from independent scientists, or peer review, the research undergoes ethics approval to be tested on humans. With approval, clinical research involving humans, begins, starting at Phase 1 to determine whether the treatment is safe, to Phase 4, which monitors the effectiveness of a treatment and its side effects after it is on the market.
Unproven stem cells therapies have not been properly tested and proven to be safe and effective.
According to Prof. Caulfield and Dr. Master, clinics offering unproven treatments share similar characteristics: They don’t provide scientific evidence of the effectiveness of a treatment and they emphasize its benefits without completely explaining its risks. Instead of scientific publications, they use patient testimonials to show the effectiveness of a therapy. Finally, the costs associated with unproven treatments are often high, while legitimate clinical trials are free.
Patients undergoing unproven stem cell therapies may develop serious health problems, as their condition may worsen, or they may require additional treatments. Undergoing an unproven treatment can also disqualify a patient for enrolment in legitimate stem cell trials.