Unauthorized Stem Cell Therapies Could Do More Harm Than Good

Stem cells have the potential answers to severe incurable diseases. However, the unauthorized and unproven uses of stem cells could be dangerous and even fatal. The US Food and Drug Administration (US FDA) has cracked down on clinics in the United States carrying out stem cell therapy without proper approvals. Stem cells are undifferentiated cells that have the potential to differentiate into other types of cells. They have a huge potential in the treatment of several incurable diseases like degenerative diseases due to their potential to repair, restore, replace and regenerate cells.

Stem cell therapy using bone marrow or cord blood is used in the treatment of blood disorders like leukemia. Corneal grafts and skin grafts obtained from stem cells are approved for use in some countries. There are several other stem cell treatments in various stages of development, which have not received approval for use in the general population.

Many people with incurable diseases sign up for clinical trials with stem cells. These patients are an extremely vulnerable group and many times take part in such trials desperately looking for a cure for their condition. Unfortunately, with the wrong treatment, they could land up with more problems, in addition to the huge costs incurred by the treatment. It is therefore necessary for anyone going in for a stem cell therapy to ensure that the clinical trial or the treatment has been approved by the regulatory authorities of the particular country.

The US FDA recently took cognizance of a stem cell treatment from a center in California due to the fact that the treatment was not only unproven but also potentially dangerous. The center used a product that was a combination of stem cells derived from body fat and the vaccinia virus vaccine to treat cancer patients. The vaccine is only used in individuals that are at a high risk for contracting smallpox, a serious viral infection that has been eradicated. The availability of the vaccine is very limited, and therefore questions have also been raised as to how the center got hold of the vaccine.

The treatment with the vaccine had the potential of causing myocarditis and pericarditis, which is inflammation of the heart muscle and its surrounding tissue, respectively, in patients with reduced immunity. Pregnant women, or people with heart disease, reduced immunity or chronic skin disease could be at a risk of suffering these complications if they came in contact with the vaccine or with individuals who have received the vaccine.

The US FDA has also issued a warning to another stem cell center for marketing stem cell products without their approval. There were also problems with the manufacturing process that could have affected the sterility of the products, thereby putting the patients at a risk of infection. The clinic used stem cells derived from body fat for conditions like Parkinson’s disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease and pulmonary fibrosis without receiving appropriate approvals from the FDA.

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The potential for stem cells in therapy is immense, and there is no doubt about it. However, all the dangers of the treatment are not yet clear and certain precautions have to be followed while going into any clinic to use such a treatment.

Thus, as a patient, if you wish to try out a stem cell treatment, it is advised not to heed to the claims of a definite cure for any condition. Ensure that the clinic you go to has adequate approvals from regulatory authorities to conduct studies on the stem cells or use them for treatment. Such precautions are necessary even if the clinic assures you that the cells will be obtained from your own body and therefore nothing can go wrong; approvals are required if the cells are reintroduced to perform a different function in your body than their original. Health care providers should also inform regulatory authorities if they come across any unauthorized practices with stem cells.

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Reference:

1. FDA acts to remove unproven, potentially harmful treatment used in ‘stem cell’ centers targeting vulnerable patients -(https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm573427.htm)
2. FDA warns US Stem Cell Clinic of significant deviations - (https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm573431.htm)

Source-Medindia