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The official blog of the Lung Institute.

Why Doesn’t the FDA Approve Our Cellular Treatment?

2 Nov 2017
| Under Disease Education, Resources, Treatments | Posted by | 16 Comments
Why Doesn't the FDA Approve Our Cellular Therapy?

You want to try cellular therapys for your chronic lung disease, but you are hesitant. Even though you’ve tried traditional treatments like inhalers, diffusers, nebulizers, even oxygen with limited results, you’re still not ready to commit.

Our Cellular Treatment Gives You Hope

You’ve done your research, and you have heard cellular therapys are the only treatment that addresses the progression of lung disease, and you know your drugs just give you temporary relief. But, you are concerned that cellular therapy for lung disease is not approved by the U.S. Food and Drug Administration (FDA). Why take the risk if the FDA won’t give its stamp of approval? Well, there is no need to worry. There is a very good reason the FDA has not approved our cellular therapy for lung disease, because currently there is no pathway toward approval and it falls under the practice of medicine, not a drug or device.

The FDA can only approve or deny drugs, medical devices, food and cosmetics. Our cellular therapys use your body’s (autologous) very own cells, so they do not fall under FDA scrutiny.

But, rest assured, under current FDA guidelines and regulations, 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.

We Are FDA Compliant

So, there it is. At this time, we have taken all the major and necessary steps to be as fully compliant and transparent as possible with our treatments. We want to assure you that you are getting the best and most advanced medical treatment available to fight your lung disease, and we want you to be as comfortable as possible with your treatment choices.

Some Want FDA Approval, Some Don’t

Interestingly, there are many people who do not want the FDA getting involved in the approval and regulation of cells. Their reasoning is cells are not a drug, cells are part of someone’s body and they say no government agency should dictate what a person can and cannot do with his or her body.

Others would like the FDA involved so that the cellular therapy business would be more tightly regulated and consequently would drive unscrupulous clinics out of business. In August, the FDA issued a warning to a cellular therapy clinic in the Miami, Fla. area commenting, “products that are reliably and carefully developed will be harder to advance if bad actors are able to make hollow claims and market unsafe science.” The FDA announced it will step up enforcement activity beginning this fall.

While the FDA does not regulate autologous cells, it’s important to note the FDA does regulate “cellular-based products.” cellular-based products are manufactured and marketed. These cells are derived and processed in a lab, and these products may come from a variety of sources.

Time for Treatment?

Cellular therapy may help people in any stage of lung disease, from stage 1 COPD to end stage COPD. If you or a loved one has COPD, emphysema, chronic bronchitis or another chronic lung disease, contact us at (800) 729-3065 to learn more about your cellular therapy options.

The Lung Institute supports National COPD Awareness Month in November sponsored by the US COPD Coalition. November 15 is designated as World COPD Awareness Day.

16 Comments

  1. Lung Institute

    5 months ago

    Tracy:

    Thank you for your comment and question. If you call one of our patient coordinators they would be happy to discuss prices with you. Most clinics and hospitals do not post prices for services online because there are many variables that can influence pricing. We want to be able to give you an accurate quote based on the information you provide.

    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. Tracy shilling

    5 months ago

    I never trust any company that can’t or won’t give me a general price range….I pay in cash.so price range is an important factor..

  3. Lung Institute

    6 months ago

    Fred:

    Thank you very much for your question. We would suggest your friend talk with your primary doctor or specialist to discuss the situation with them. We may offer help for someone with a chronic lung disease but do not and cannot offer any diagnosis for a different situation.

    We’re happy to answer your questions regarding lung diseases. Feel free to give us a call at (855) 313-1149 to speak one-on-one with our dedicated medical team. We look forward to hearing from you soon.

    Sincerely,

    The Lung Institute

  4. Lung Institute

    6 months ago

    Richard:

    Thank you for your comment. We have done research and continue to do research to make sure the patient receives the best quality of care. We have published a White Paper with our latest findings, which you can find on our resources page. 84.5% of patients included in the study report an improvement in their quality of life after receiving treatment from a Lung Institute clinic.

    For more information about treatment options and about our study, please feel free to contact us at (855) 313-1149.

    Sincerely,

    The Lung Institute

  5. fred

    6 months ago

    can you still expect to get better if you had part of your lung taken out due to tumor? this is for my dear friend. please reply, and thank you

  6. Richard

    6 months ago

    lots of info on treatment

    not much on results

  7. Lung Institute

    7 months ago

    Linda:

    Thank you for your question.

    Treatment cost varies depending on treatment type. We understand that each patient is unique and has individual needs. Because of that, we make sure to go over the patient’s history and our treatment options in detail with each patient. In order to determine if someone is a candidate for treatment, we need to gather more of their private medical history in a secure setting. The best way to do that is by giving us a call and speaking one-on-one with someone on our medical team over our secure phone line. We’re happy to answer your questions about cells, treatment options, candidacy and cost.

    So, feel free to contact us lat (855) 313-1149. We look forward to hearing from you soon.

  8. linda grieco

    7 months ago

    what is the cost?

  9. Lung Institute

    7 months ago

    Patrick:

    Thank you for your comment and we are sorry to hear about your condition.

    Treatment cost varies depending on treatment type. In order to best answer your question, we need to gather more private medical information from you over our secure phone line. Our team has a wealth of knowledge about cellular therapy, treatment, candidacy and cost. We’re happy to answer your questions. Feel free to give us a call at (855) 313-1149 to speak one-on-one with our dedicated medical team. We look forward to hearing from you soon.

    Sincerely,

    The Lung Institute

  10. Patrick DJ Torres Sr

    7 months ago

    I am suffering currently with early onset of Fibrosis, and am wondering what the average cost of the cellular treatment is ? While I would love to live longer and manage this horrible affliction, I surely don’t want to wipe out our retirement savings. can you please provide an average dollar amount this therapy would cost me ? thanks for all your wonderful work on our behalf, and I wish you great success always !

  11. Lung Institute

    7 months ago

    Charles:

    Thank you for your question and we are sorry to hear about your condition.

    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

  12. Charles Basiks

    7 months ago

    I have COPD and my doctor tells me I am in the severe stages. Can you tell me if thus treatment us covered by insurance or medicare ? I am 75 and retired and have medicare and United health insurance.

  13. Lung Institute

    7 months ago

    Suhail:

    We are sorry to hear about your mother’s medical condition. We’re happy to answer your questions about cellular therapy for COPD. Our dedicated medical team has a wealth of knowledge about cellular therapy, treatment options, candidacy and more. So, we encourage you to call us at your convenience at (855) 313-1149 to speak one-on-one with someone from our medical team over our secure phone line. We look forward to hearing from you soon.

    Sincerely,

    The Lung Institute

  14. suhail

    7 months ago

    Lung Institute:
    esteemed all, greetings. my name is suhail i am from Kashmir. my mother is suffereing with emphysema and copd. i got to learn about cellular treatment. i would need more details about the same medication. it would be great if you could drop an email or call on given details.
    email: suhail.nabi87@gmail.com
    contact number:- +96596923720.

    i shall be awaiting for your call

  15. Lung Institute

    7 months ago

    Marvin:

    Thank you for the comment. We are glad you are doing your research and due diligence. We know it is a big step. Is there any particular issue that was preventing you from making the move?

    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.

    Sincerely,

    The Lung Institute

  16. Marvin James

    7 months ago

    I am one of those that have been sitting on the sidelines thinking about this treatment. The more I think about it, the more I like what I see and read.

* Every patient is given a Patient Satisfaction Survey shortly after treatment. Responses to the 11-question survey are aggregated to determine patient satisfaction with the delivery of treatment.

^ Quality of Life Survey data measured the patient’s self-assessed quality of life and measurable quality of improvement at three months.

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.

Each patient is different. Results may vary.