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Drugs Vs Treatment: Where Stem Cell Therapy Stands with the FDA

8 Aug 2016
| Under FAQs | Posted by | 8 Comments
Drugs Vs Treatment: Where Stem Cell Therapy Stands with the FDA

Stem cell therapy is classified as a treatment and not a drug. So what’s the difference?

A common question we receive at the Lung Institute is whether stem cell therapy is approved by the FDA? As we’ve mentioned before, our stem cell therapy procedures comply with FDA regulation; however, there are a variety of procedures involving Human Cells, Tissues and Cellular and Tissue-based products (HCT/Ps) that do fall under FDA regulation. The understandable follow-up is often why? The answer is that the need for regulation directly depends on several factors: are the HCT/P’s withdrawn and returned to the patient (autologous)? Are they delivered to the patient within a same-day procedure? And are the cells that are being used manipulated, and to what degree? This simple distinction could mean the difference between being classified as a drug or a treatment.

With your health in mind, the Lung Institute is here to focus on HCT/P manipulation and treatment classification, providing a breakdown on the complexities of FDA regulation and giving you a concrete and simple answer to the question of Drugs vs Treatment: Where Stem Cell Therapy Stands with the FDA.

Minimally Manipulated (Treatment)

When it comes to FDA regulation of HCT/Ps, the primary distinction between treatments and drugs are whether they have been minimally manipulated or significantly manipulated. In the case of minimal manipulation, more often than not, a procedure will be exempt from further FDA regulation under the clauses provided in regulations 1271.10 and 1271.15.

Specifically, these three criteria must be met:

  • The treatment must remove and implant the HCT/Ps into the same individual from whom they were removed (autologous use)
  • The treatment must implant the HCT/Ps within the same surgical procedure (same day procedure); and
  • The treatment must allow the HCT/Ps [to] remain in their original form (minimal manipulation)

If the treatment is able to meet these required regulations, particularly the “same procedure” clause, then it falls under the practice of medicine as a surgical procedure.

Drugs Vs Treatment: Where Stem Cell Therapy Stands with the FDA

Manipulated (Drugs)

On the other hand, in regards to HCT/Ps that are determined to be more than minimally manipulated—or significantly manipulated—they immediately fall under the category of drugs and must, therefore, follow further FDA regulation. During this process, an HCT/P classified as a drug must follow the appropriate steps of a typical Investigational New Drug (IND). It must first apply, then devote about 10-15 years to conducting clinical trials.

A notable example of changes to genetic material that can alter an HCT/P from minimally manipulated to significantly manipulated would be the use of amniotic membrane. If you were to decellularize the membrane and leave it as a whole sheet, this would be considered minimal manipulation. However, if you were to use this genetic material and turn it into a powder after decellularization, this would be considered more than minimal manipulation because the processing alters the membrane’s ability to serve as a membranous barrier, and ultimately drug manufacturing. The deciding factor rests in the integrity of the tissue.

Here’s the Short Version

  • Our stem cell therapies meet exemption status by the FDA due to the fact that they are not considered a drug.
  • For a treatment to be considered a drug, it must be more than minimally manipulated before being introduced to a patient.
  • For a stem cell treatment to be considered minimally manipulated, the processing of cell or non-structural tissue must not alter any relevant biological characteristics of the cells or nonstructural tissues.
  • Autologous stem cells must be administered within same surgical procedure to meet FDA exclusion requirements.

Drugs vs Treatment: Where Stem Cell Therapy Stands with the FDA? And What This Means for You…

If you’re looking to take a more proactive approach to treatment, it’s time to consider stem cell therapy. Rather than only addressing the symptoms of lung disease, stem cell therapy may directly affect disease progression, may improve quality of life and pulmonary function within patients. For those who suffer from lung disease, a change in quality of life could mean the difference between struggling to walk to the mailbox and riding a bike.

If you or a loved one suffers from a chronic disease like COPD, pulmonary fibrosis, emphysema or other symptoms of lung disease, the Lung Institute may be able to help with a variety of adult stem cell treatment options. Contact us today at (800) 729-3065 to see if you qualify for stem cell therapy, and find out what stem cell therapy could mean for you.

Still wondering about Drugs vs Treatment: Where Stem Cell Therapy Stands with the FDA? Share your thoughts and comments below.


  1. PB

    7 months ago

    Dear DeWayne,

    At this time, insurance companies, including passport insurance, don’t cover treatment. While we are hopeful that treatment will be covered in the future, it will take some time before insurance companies see a financial benefit in their favor and then decide to cover treatment. Treatment cost varies depending on treatment type, so it’s best to speak one-on-one with one of our patient coordinators. They have a wealth of knowledge about stem cells, treatment options, candidacy and cost. Feel free to contact us at (855) 313-1149. We look forward to speaking with you soon.

    Kind Regards,

    The Lung Institute

  2. PB

    7 months ago

    Dear DeWayne,

    Unfortunately, at this time, insurance companies don’t cover treatment. However, we’re hopeful that treatment will be covered by insurance companies in the near future. Keep in mind that it will take some time before the insurance companies see a financial benefit in their favor and then decide to cover it. In the meantime, you can learn more about stem cell treatment options and have your questions answered by one of our patient coordinators. Feel free to contact us at (855) 313-1149 for more information. We look forward to hearing from you soon.

    Best Regards,

    The Lung Institute

  3. DeWayne S Williams

    7 months ago

    Does passport insurance cover this,how much does all this cost?

  4. DeWayne S Williams

    7 months ago

    Does passport insurance cover this

  5. Cameron Kennerly

    8 months ago

    Hello Jeanne,

    First and foremost we’d like to thank you for your question. Unfortunately, at this time traditional insurance companies such as HMO’s and Medicare have not yet begun to cover stem cell therapy as a form of treatment. However, this doesn’t mean that stem cell therapy is necessarily out of reach. For more information, please give us a call at (855) 313-1149 to speak with one of our patient coordinators on a few alternative methods to cover treatment.

    We look forward to hearing from you,

    -The Lung Institute

  6. Jeanne

    8 months ago

    Does medicare cover this treatment?

  7. PB

    8 months ago

    Dear Christa,

    Thanks for your questions. We have treated patients of all ages. Some of our patients have been in their forties while others have been in their eighties and nineties, so age isn’t an issue. We’re happy to answer your questions regarding stem cell therapy, so feel free to contact us at (855) 313-1149 to speak one-on-one with a patient coordinator to have your questions answered. We look forward to speaking with you soon.

    Kind Regards,

    The Lung Institute

  8. Christa Byars

    8 months ago

    How does one know whether the stem cells taken from their blood are viable/capable of being of value as a treatment for one’s lung disease?? I am 73 years old, are my stem cells good enough to be used to treat my IPF??

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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. 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.