Stem Cell Therapy and the FDA Approach to It

Stem Cell Therapy and the FDA Approach to It

Dec 03, 2020 | Author : MedicW

Stem cell therapy has witnessed a positive emergence in recent years. This is due to its application to treating a wide range of diseases that continue to affect humankind. Generally classified as regenerative medicine, this treatment aids the regeneration of diseased cells and injured tissues in humans.

Still, while this medical treatment’s positives are considerable, it is not without its side effects. As such, like most medical emergence, this treatment has attracted its fair of negative reviews. As expected, the Food and Drug Administration (FDA) has had significant impacts on this treatment.

It has approved various products in recent times. Even more, a few more remain in clinical development and are set to get approved in the coming years. The FDA also maintains various legislations to ensure the regulation of the application of stem therapies. This article provides an overview.

Stem Cells and FDA Regulation

Currently, the FDA is responsible for regulating stem cell products within the United States of America. This body oversees the assessment of products to determine their effectiveness, and more importantly, their safety.

This gets achieved through controlled studies in humans regarded as clinical trials. These trials allow the FDA to obtain reports and data of the trial to determine whether the procedures and processes comply with the acceptable standards.

The FDA also manages a comprehensive review of the production process to stem cell products. It achieves this by obtaining details of the manufacturing process. In turn, it determines whether the product’s purity, potency or strength, and safety satisfy the necessary industry standards. There is also the need for the provision of associated and potential risks.

So far, only a few treatments have received the FDA’s approval concerning the application of stem cell therapy. Regardless, various clinics continue to advertise stem products inappropriately and falsely without the FDA’s prior approval.

Worse, some clinics have falsely advertised that the approval of the FDA is somewhat unnecessary. Unfortunately, this is far from the facts, but it is also dangerous for patients to succumb to such false statements as it can negatively affect their health.

Note that in recent times the FDA has responded to these various inappropriate statements through various publications. These various publications are statements to clarify the false hopes circulated by various clinics.

Similarly, in June 2019, the FDA made a release that projected a permanent injunction against various stem cell clinics within the country. This is to reduce the widespread risk that false clinics pose to the health of the general community. 

Subsequently, the FDA took various steps to provide extra protective layers for patients. This is thanks to the significant risk that comes with the use of stem cell products that have failed to receive the FDA’s approval.

In the same vein, new regulations emerged to ensure reduced stem cell therapy availability to people within the United States. This was to increase and implement stringent quality control measures to protect the lives of the citizens of the United States of America. 

Safety Issues for Unapproved Stem Cell Therapies 

The application of medical treatments usually attracts both advantages and disadvantages. These advantages take the form of recovery from the illness. The disadvantages, on the other hand, takes the form of side effects. This is the same with stem cell treatments.

With approved treatments, the goal is to minimize side effects to the barest minimum and, where possible, eliminate them. However, with unapproved treatment, the risk of these side effects becomes greatly increased. This is the case with unproven and unapproved stem cell treatments.

In 2016, at the FDA public workshop, various cases of severe side effects to stem cell treatment emerged as a topic for discussion. For instance, a participant got blind upon the eye insertion of stem cells. There was also the case of spinal tumor growth upon spinal cord insertion. These, among others, establish a high level of risk that patients can face from opting for an unproven procedure. 

Unfortunately, this is far from the only risk posed by stem cell treatment. Other possible side effects include:

  • Reactions in the administration area
  • Failure to obtain the expected cell activities
  • Emergence of tumors
  • Movement of cells from placement area and multiplying inappropriately or transitioning to inappropriate types of cells 

Keep in mind that these reactions do not get excluded because the cells are your cells. With unproven treatments, these risks remain ever-present.

Patients and FDA 

Patients must keep in mind that the FDA’s activities are to protect patients from unnecessary medical issues when seeking treatment. As such, patients must understand that the FDA plays an essential role in the oversight of stem cell treatment. The fact that they are your cells does not exclude the oversight of the FDA.

Even more, keep the following in mind when considering treatment within the United States of America.

  • Ensure that the FDA has reviewed and approved the treatment. You can confirm with your healthcare provider about this. You can also request the Investigational New Drug Application Number from the clinic. You can always go further to assess the correspondence with the FDA. Now, ensure you do this before you start treatment. 
  • Always ask for clarification concerning anything you do not understand—request for the brochure to get the hang of all relevant information.

If you are obtaining the stem cell treatment outside the US, do well to keep the following in mind.

  • Obtain information about the relevant regulations in that country 
  • Keep in mind that the authority of the FDA does not extend to that country 
  • Exercise caution and request clarification on all issues

Final Thoughts

The FDA is the primary regulatory authority when it comes to stem cell treatment. Over the years, it has taken a stringent approach to ensuring the protection of patients’ rights. This is to ensure quality health care.

As such, it is necessary as a patient to understand that the FDA exists to protect you. In turn, do well to utilize only its approved treatments.