Exhale

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 therapy 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 therapy is 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 treatment, 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 therapy uses your body’s very own cells (autologous), 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 888-745-6697 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.

* 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 of COPD patients.

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.