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Stem Cell Therapy and the FDA: Is it Approved?

13 Jun 2016
| Under Resources | Posted by | 3 Comments
Stem Cell Therapy and the FDA: Is it Approved?

It’s a straightforward question, so here’s a straight answer.

At the Lung Institute, where we utilize autologous stem cell therapy–stem cells collected from the patient’s own body–for the treatment of lung diseases such as COPD, pulmonary fibrosis and emphysema, one of the most frequently asked questions we receive is whether or not stem cell therapy is approved by the FDA. Understandably, current and potential patients wish to gain a deeper understanding as to how and why the Lung Institute exists—particularly in a field of medicine that may feel new and rapidly advancing.

With your health in mind, the Lung Institute is here to break down the role of the FDA, its approval process and exactly where stem cell therapy falls on the spectrum of FDA regulation and guidelines.

Quick Overview

In short, the use of same-day autologous stem cell therapy is approved for exemption status by the FDA.  So, what does exemption status mean exactly? In this case, exemption status simply means that when criteria and guidelines are met in the practice of stem cell therapy, the FDA has preemptively permitted its use and has determined that no further regulation or oversight is required. In this sense, the Lung Institute is firmly in accordance with the conditions set by the FDA for exemption status and conducts itself in full accordance with current guidelines.

Stem Cell Therapy and the FDA: Is it Approved?

What is the FDA?

In 1906, journalist Upton Sinclair drafted the novel The Jungle—a fictionalized expose of deplorable meatpacking conditions in industrial Chicago. At a time in which virtually all consumers were unaware of the safety and cleanliness of their sources of food, once the novel broke, public outrage over the conditions presented in the book led to immediate action in the form of two bills: the Meat Inspection Act and the Pure Food and Drug Act of 1906. These bills would eventually lead to the establishment of the Bureau of Chemistry, which in turn, would become what we know today as the Food and Drug Administration (FDA).

So, what exactly does the FDA do? In short, the FDA is responsible for protecting and promoting public health through the regulation and supervision of food, tobacco and medical products. They exist as an extension of their original purpose: to protect the health of the consumer by regulating the industries that are most important to public health.

Stem Cell Therapy Moving Forward

Under current FDA guidelines and regulations 1271.10 and 1271.15, the Lung Institute is in compliance with all necessary requirements for operation. Our procedures are same day, involve minimal manipulation and are, therefore, considered office-based medical procedures in much the same way that one might go to the dentist. Although stem cell therapy can seem new and unfamiliar, rest assured these procedures fall under the practice of medicine and do not require further FDA oversight.

At the Lung Institute, we believe stem cell therapy is quickly growing to become the dominant form of treatment for lung disease. However, time can be a factor in any decision. If you’re looking to take control of your health, don’t wait. If you or a loved one suffers from COPD or another lung disease, the Lung Institute may be able to help with a variety of stem cell treatment options. Contact us at (800) 729-3065 today to find out if you qualify for stem cell therapy.

Still wondering about Stem Cell Therapy and the FDA: Is it Approved? Share your thoughts and comments below.


  1. Pingback: Drugs Vs Treatment: Where Stem Cell Therapy Stands with the FDA | Lung Institute

  2. PB

    2 years ago

    Dear Linda,

    Thank you for your question. Unfortunately, stem cell treatment is still not covered by insurance companies. It can take some time for procedures to become covered by insurance companies. We agree with you that it would be wonderful if insurance companies covered treatment. However, we are hopeful that treatment will be covered in the future. We’re happy to answer any questions you have about stem cell treatment options, so feel free to contact us at (855) 313-1149 to speak with a patient coordinator. We look forward to hearing from you soon.

    Best Regards,

    The Lung Institute

  3. Linda Mann

    2 years ago

    So does that mean some of the insurance companies may be willing to pay for this procedure now. It would be wonderful if they would.

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* All treatments performed at Lung Institute utilize autologous stem cells, meaning those derived from a patient's own body. No fetal or embryonic stem cells are utilized in Lung Institute's procedures. Lung Institute aims to improve patients' quality of life and help them breathe easier through the use of autologous stem cell therapy. To learn more about how stem cells work for lung disease, click here.

All claims made regarding the efficacy of Lung Institute's treatments as they pertain to pulmonary conditions are based solely on anecdotal support collected by Lung Institute. Individual conditions, treatment and outcomes may vary and are not necessarily indicative of future results. Testimonial participation is voluntary. Lung Institute does not pay for or script patient testimonials.

Under current FDA guidelines and regulations 1271.10 and 1271.15, the Lung Institute complies with all necessary requirements for operation. The Lung Institute is firmly in accordance with the conditions set by the FDA for exemption status and conducts itself in full accordance with current guidelines. Any individual who accesses Lung Institute's website for information is encouraged to speak with his or her primary physician for treatment suggestions and conclusive evidence. All information on this site should be used for educational and informational use only.

As required by Texas state law, the Lung Institute Dallas Clinic has received Institutional Review Board (IRB) approval from MaGil IRB, now Chesapeake IRB, which is fully accredited by the Association for the Accreditation of Human Research Protection Program (AAHRPP), for research protocols and stem cell procedures. The Lung Institute has implemented these IRB approved standards at all of its clinics nationwide. Approval indicates that we follow rigorous standards for ethics, quality, and protections for human research.