Lung Institute to Attend FDA Hearing on Stem Cell Regulation

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The Lung Institute offers stem cell therapy for people with chronic lung diseases. Lung Institute staff members will be in attendance at the FDA Hearing on stem cell regulation on Sept. 12 and 13 to be a part of the conversation.

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The new cell-based therapies are altering how medicine is practiced, and the previous checks and balances that had served the field well for so long must be changed to keep pace with the progress being made.

Lung Institute staff members, specializing in stem cell therapy for chronic lung disease, will attend the FDA hearing on stem cell regulation on Sept. 12 and 13. The hearing will bring together policymakers, researchers, clinicians and patients to discuss regulation of clinical application of stem cell therapy. The hearing will potentially increase regulation for stem cell therapy clinics.

“We’re looking forward to being a part of the conversation, and support new regulations that put patient safety first,” stated Jack Coleman, Jr., M.D., medical director of the Lung Institute. “The new cell-based therapies are altering how medicine is practiced, and the previous checks and balances that had served the field well for so long must be changed to keep pace with the progress being made.”

According to Dr. Coleman, there will be two main groups in attendance at the hearing: those who are pushing for more research and those who are pushing for clinical application today.

The group that is calling for more research before clinical practice believes we have not yet confirmed the efficacy or safety of stem cells. Some criticize anecdotal evidence, such as patient testimonials, claiming it is not enough evidence to prove success.

The other side asserts that patients don’t have time to wait for costly double-blind placebo-controlled studies. They are also confident that the existing evidence is sufficient in showing that stem cell treatments are safe and effective.

“I support the researcher’s efforts. What they want to achieve is completely understandable, and laudable,” said Dr. Coleman. “However, we do not, and cannot expect the perfect cure before we try to help people.”

Although in its early stages, stem cell research suggests that stem cell therapy for lung disease is safe and effective.

Phase I clinical trial of cell therapy in patients with advanced chronic obstructive pulmonary disease: follow-up of up to 3 years, published in the Brazilian Journal of Hematology and Hemotherapy, states that:

The results showed that autologous cell therapy in patients having chronic obstructive pulmonary disease is a safe procedure and free of adverse effects. There was an improvement in laboratory parameters (spirometry) and a slowing down in the process of pathological degeneration. Also, patients reported improvements in the clinical condition and quality of life.

Further, in, Mesenchymal stem cell therapy in lung disorders: Pathogenesis of lung diseases and mechanism of action of mesenchymal stem cell, published in the National Center for Biotechnology Information, the following conclusion is drawn:

Availability of MSCs [mesenchymal stem cells] from different sources provides a safe, rich and inexpensive source of MSCs for treatment of lung diseases. Their unique properties in homing, immunomodulation, regeneration, and secretion of anti-inflammatory cytokines make them an ideal candidate for the treatment of challenging lung conditions like chronic asthma, ARDS [acute respiratory distress syndrome], COPD [chronic obstructive pulmonary disease], and ILD [interstitial lung disease] and considered to be well placed in reducing morbidity and mortality associated with such lung conditions.

Both of the aforementioned studies are specifically centered around lung diseases. Many stem cell clinics claim that stem cell therapy is a “cure all,” miraculously healing a myriad of diseases. Researchers advise to stear clear of clinics making claims that sound too good to be true. Further, the clinic should collect and publish data that summarizes their outcomes. These are just a few topics that will likely be discussed at the hearing.

The Lung Institute collects and publishes patient outcomes. They released updated findings yesterday, building on the number of patients included in their in-house pilot study, Autologous Stem Cell Therapy and its Effects on COPD, authored by Dr. Coleman.

The new data indicates that 84.5 percent of COPD patients perceive some sort of improvement in their quality of life after receiving stem cell therapy from the Lung Institute. Further, 60 percent of COPD patients studied saw an improvement in their pulmonary function test scores. Of those who saw pulmonary function improvement, 49.1 percent saw improvement of 10 percent or higher.

Just over 149,000 people die each year in the United States alone from chronic lung disease-related problems.

“I cannot, in good conscience, tell someone with two years to live that I will offer him nothing new because there will be a ‘cure’ available in four years,” said Dr. Coleman. “That does my patient no good, and I will have failed him. But if there is something I can do to extend or maintain his quality of life, or, ideally, prolong his life to when a cure is available, then I will have performed consistently with my calling.”

The FDA hearing on Sept. 12 and 13 will take place at the National Institutes of Health Campus near Washington, D.C. The hearing will facilitate an open conversation among all stakeholders – policymakers, clinicians, researchers and the public. Those with opposing views will discuss draft guidances relating to the regulation of human cells, tissues and cellular and tissue-based products (HCT/Ps). Many key influencers will present at the conference, including Johnson & Johnson, American College of Surgeons, NYU Langone Medical Center and Alliance for Regenerative Medicine, among others.

Many patients who have personally experienced success from stem cell therapy will also be in attendance, including one man who claims he was cured of blindness.

“People like [him], who have benefitted so greatly from these new medical breakthroughs, are the voice of those who are suffering and in need right now,” said Dr. Coleman. “I admire, respect and applaud him, and encourage him to continue to carry the banner for these people through the halls and into the offices of our representatives in our nation’s capitol.”

For more information about the hearing, visit

About the Lung Institute

The Lung Institute is a leading medical provider of regenerative cellular therapy for lung diseases such as chronic obstructive pulmonary disease (COPD), pulmonary fibrosis and interstitial lung disease in the United States. To date the organization has treated over 2,500 patients. The Lung Institute’s in-house outcomes summary shows that 83 percent of patients studied saw an improvement in their quality of life. Founded in 2013 in Tampa, Fla., the Lung Institute currently operates clinics in Tampa, Fla., Nashville, Tenn., Scottsdale, Ariz., and Pittsburgh, Pa. and Dallas, Texas. For more information, please visit or call (800) 382-8095.

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