The official blog of the Lung Institute.
The American Lung Association directs visitors seeking information about stem cell treatments for lung disease to the International Society for Stem Cell Research (ISSCR). The ISSCR is an independent, nonprofit organization established to promote and foster the exchange and dissemination of information and ideas relating to stem cells, encourage the general field of research involving stem cells and promote professional and public education in all areas of stem cell research and application. The ISSCR has put together a useful list of questions to ask a stem cell clinic. We have put together a list of answers from the Lung Institute team to help you make an educated decision about whether or not stem cell therapy for lung disease is right for you.
Questions to Ask a Stem Cell Clinic
Is the treatment routine for this specific disease or condition?
- The application of stem cell treatments for a variety of disorders has only been performed in clinical settings for a little over a decade—a relatively short period of time in the field of advanced medicine. Because stem cell therapy is still considered new and innovative it has not undergone clinical translation, or the act of becoming a mainstream (Food and Drug Administration sanctioned) treatment for lung disease. Although, it continues to grow in popularity due to the growing number of patients seeing consistent positive results. Credible organizations such as the National Institutes of Health (NIH) and the Mayo Clinic see the potential benefit for stem cell therapy in treating lung disease and continue to make stem cell treatments the subject of extensive research and case studies.
- At the Lung Institute, it is our first priority to treat lung disease with stem cell therapy. Our chief physician has been practicing medicine for over half a century and is considered an expert in the field of regenerative medicine. Since inception, we have helped people improve their quality of life.
Is the treatment part of a formal clinical trial?
- No, the stem cell treatments provided at the Lung Institute are not currently a part of a formal clinical trial. We are an independent organization offering stem cell treatments to individuals looking to treat not only their symptoms, but their disease.
What are the alternative treatment options for my disease or condition?
- This question is dependent on the nature of an individual’s exact condition. However, common treatments for lung diseases such as chronic obstructive pulmonary disease (COPD), emphysema, chronic bronchitis, and pulmonary fibrosis include:
- Inhaled steroids
- Combination inhalers
- Oral steroids
- Phosphodiesterase-4 inhibitors
- Pulmonary therapies and rehab
- Lung volume reduction surgery
- Lung transplant
If I have this treatment, could it affect whether I get into a clinical trial or am I able to have another treatment?
- If you are seeking an opportunity to be a candidate in a clinical trial, this is a question that you will have to discuss with the trial coordinator. There are a multitude of factors that will affect the judgment of this decision. The results of our stem cell therapy typically appear around 3 to 6 months post-treatment. In order to not interfere with your results, we would suggest not participating in a clinical trial if you are undergoing our treatments.
What are the possible benefits I can expect? How will this be measured and how long will this take?
- Our patients are seeing significant improvement in their overall pulmonary function and in the performance of everyday activities. Physical performance varies from patient to patient, as each individual case is different. To view our testimonials, click here.
- We measure performance by administering a pulmonary function test (PFT) prior to treatment, and then again following treatment. We also use various other measurement techniques. Speak to a Lung Institute coordinator to learn more.
- The treatment is performed over the course of three days with each treatment only taking a few hours. All of our procedures are outpatient so you can return to the comfort of your hotel or accommodations after treatment.
What other medications or special care might I need?
- Following your treatment we will put together a care plan based on your needs. This may or may not include recommendations for additional medications. We advise that you stay under the care of your current pulmonologist or PCP for care unrelated to our treatment.
What is the source of the stem cells?
- All stem cells utilized by Lung Institute are autologous, meaning they come from the patient’s own body. Due to this fact, our procedures are considered very safe and there is a minimal likelihood of graft vs. host disease.
How are the stem cells identified, isolated and grown?
- The stem cells are collected either from the blood through the use of an IV, or from bone marrow tissue. The stem cells are then taken to the lab where they are spun in a centrifuge. This will allow the stem cells to separate from the blood or bone marrow; they are then separated, and immediately re-administered back into the patient.
How are the cells delivered to the right part of the body?
- We deliver the stem cells intravenously and/or through the use of a nebulizer.
If the cells are not my own, how will my immune system be prevented from reacting to the transplanted cells?
- All stem cell therapies performed at Lung Institute utilize stem cells from the patient’s own body.
Scientific evidence and oversight
What is the scientific evidence that this new procedure could work for my disease or condition? Where is this published?
- Please review the case studies in our research section supporting our treatments by clicking here.
Have there been (earlier) clinical trials? What was learned from these trials?
- There have been a variety of clinical trials performed to determine the efficacy of stem cell therapies for lung disease. To be directed to the NIH website and learn more about these trials, click here.
- You can search for clinical trials using stem cells (or other methods) to treat a specific disease at ClinicalTrials.gov.
Is there any independent oversight or accreditation of the clinic where the treatment will be done and the facility where the cells are processed?
- We are currently in the process of adopting an Institutional Review Board (IRB) to review our treatments. We will update the answer to this question when our findings have been published.
Is there approval from national or regional regulatory agency, such as the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), for this treatment of this specific disease?
- All of Lung Institute’s medical tools and machinery are FDA-approved. We are also HIPPA Compliant, and First Healthcare Compliant.
- Stem cell treatments are not currently approved by the FDA.
Safety and emergencies
What are the risks of the procedure itself, and the possible side effects both immediate and long-term?
- There are very little risks involved from our stem cell therapy procedures. Because the stem cells come from the patient’s own body, our procedures are considered quite safe and effective. A Lung Institute physician will go over all possible side effects and allergic reactions that can occur. Please give us a call today to learn more.
What will be done if an adverse reaction (bad side-effect) develops? Who is the person to contact in an emergency or research-related injury? Who will provide emergency medical care?
- If a life-threatening emergency occurs, please contact 911 immediately. If you have any questions or concerns about possible side effects contact our office at (800) 729-3065.
Is the clinic adequately prepared to handle emergencies such as a serious allergic reaction?
- Yes, we have an MD on call and an ARNP in our office at all times.
What follow-up treatment will be received, and for how long? What will I need to do?
- Follow-up treatments are contingent on the success of the patient’s outcome. Many patients choose to have a follow-up treatment performed to keep up the positive momentum.
Who is the doctor in charge of the treatment? What specialized training does this doctor have? How well trained are the other doctors and the technical support staff?
- Each clinic is overseen by a board certified physician that has taken the additional steps to educate themselves about the functionality of stem cells in treating lung disease. To learn more about our clinic’s staff, click here.
What are my rights as a participant—for example confidentiality, my right to be informed of any new information that might come up, my right to withdraw from the treatment process?
What are the costs of the treatment? What does this include? What other costs will I incur?
- We offer two different types of stem cell therapy. Each therapy has a different cost, to learn more about the cost of our treatments contact us today at (800) 729-3065. Please note that currently insurance does not cover the cost of treatment.
Please Note: The answers to these questions were put together by the Lung Institute team and have no connection to the ISSCR or the American Lung Association. All of these answers were compiled in an effort to increase transparency in regards to our stem cell practices and to help educate patients.