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Drugs Vs Treatment: Where Cellular Treatment Therapy Stands with the FDA

8 Aug 2016
| Under FAQs | Posted by | 12 Comments
Drugs Vs Treatment: Where Cellular Therapy Stands with the FDA

Cellular 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 cellular therapy is approved by the FDA? As we’ve mentioned before, our cellular 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 The answer is that the need for regulation directly depends on several factors: are the HCT/P’s withdrawn and returned to the patient? 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 Cellular 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
  • 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 Cellular Therapy Stands with the FDA

Manipulated (Drugs)

On the other hand, in regard 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 cellular 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 cellular therapy 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.
  • Cells must be administered within same surgical procedure to meet FDA exclusion requirements.

Drugs vs Treatment: Where Cellular 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 cellular therapy. Rather than only addressing the symptoms of lung disease, cellular 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 cellular therapy options. Contact us today at (800) 729-3065 to see if you qualify for cellular therapy, and find out what cellular therapy could mean for you.

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

12 Comments

  1. Lung Institute

    5 months ago

    Gary:

    Thank you for your comment. We encourage you to see if the VA would cover it.

    Unfortunately, at this time, Medicare, Medicaid and insurance companies don’t cover treatment. However, we’re hopeful that treatment will be covered 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. We’re happy to answer your questions about cellular therapy for chronic lung diseases. We have a dedicated medical team who have a wealth of knowledge about cellular therapy, treatment options, candidacy, cost and more. So, feel free to give us a call at (855) 313-1149. We look forward to hearing from you soon.

    Sincerely,

    The Lung Institute

  2. Gary Yates

    5 months ago

    I’m going to TALK.My primary care provider see if maybe I can get the VA to cover this, I got shoulder replacement surgery done, took 3 years

  3. Phoebe

    1 year ago

    Dear Santiago,

    Thanks for your questions. After treatment at the Lung Institute, our medical staff follows-up with the patients to see how they are doing and to gather additional information. During that time, the medical staff will let the patients know about booster treatment options. While a booster treatment is not required after the initial procedure, having a booster treatment may help continue to promote healing within the lungs. Our medical staff can answer you questions about cellular treatment, booster treatments, candidacy and cost. So, feel free to contact us at (855) 313-1149, and we look forward to hearing from you soon.

    Best Regards,

    The Lung Institute

  4. Santiago

    1 year ago

    After a treatment, does the patient have to go back to lung institute for another procedure? If so, how often is the frequency? Do we have to pay the same price for another procedure?

  5. PB

    2 years 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 cellular therapy, 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

  6. PB

    2 years 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 cellular 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

  7. DeWayne S Williams

    2 years ago

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

  8. DeWayne S Williams

    2 years ago

    Does passport insurance cover this

  9. Cameron Kennerly

    2 years 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 cell therapy as a form of treatment. However, this doesn’t mean that 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

  10. Jeanne

    2 years ago

    Does medicare cover this treatment?

  11. PB

    2 years 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 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

  12. Christa Byars

    2 years ago

    How does one know whether the 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 cells good enough to be used to treat my IPF??

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.

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 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.