Installment 82 - Ask The President/Kathy Hebert/AACT

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Jeannine

Pioneer Founding member
About the AACT

Kathy Hebert is the President and Co-Founder of the Alliance for the Advancement of Cellular Therapies (AACT).She works to build strategic alliances and to implement collaborative projects for the mission of advancing regenerative medicine and increasing access for patients to cellular therapies.

AACT is a grassroots movement raising awareness for regenerative medicine for and educating medical professionals and consumers on the facts and benefits of regenerative medicine. AACT supports an evidenced based approach built on open collaboration among industry thought leaders, professional medical associations and healthcare advocates through public and industry events and promotions to support the clinical translation of research into technologies and treatments that serve patients and improve their quality of life.

Kathy's personal experience with life-changing cellular therapies ignited her passion to be involved with an innovative new area of medicine bringing together the industry leaders in regulatory, science, and medicine to yield the best possible patient outcomes. Her skills include non-profit development and compliance, regenerative medicine regulatory information, international and domestic conference planning, and digital marketing/analytics. Kathy participates in the organizational branding, business strategy, membership procurement, marketing, conference and event planning/implementation, financial decisions and budgeting.

Kathy Hebert
Kathy@AACT.co
AACT.co
864-353-5781

Questions & Answers

Q: The AACT website says "We have an exclusive focus on research utilizing autologous and allogeneic adult stem cells." What is the reason for this? Are there different stem cell therapies; aren't they all the same?
A: There are many different types of cellular therapy.
Because adult stem cell knowledge is farther along in its translation from research to the clinic than other therapy methods, adult stem cells are, therefore, being tested for many different diseases in human clinical trials.

Diseases treated by adult stem cells include Osteoarthritis • Arthritis • Tendonitis • Variety of cancers • Non-healing bone fractures • Cardiovascular Disease • Neurodegenerative Diseases • Psoriasis • Alopecia • Non-healing ulcers • Diabetic wounds • Stress incontinence • Multiple Sclerosis • Diabetes, and many more.

Sources for these cells are derived from bone marrow, fat (adipose) or blood. Because the cells originate from your own body (autologous), they do not carry the added concerns of rejection or the spread of communicable diseases.

The adult stem cell category also includes umbilical cord derived tissue. This tissue is called allogeneic because it does not come from your body. This therapy has shown to modulate the immune system so that the disease is attacked rather than the person’s body.

AACT focuses on both autologous and allogeneic stem cells because they have the highest likelihood of providing therapies for patients either currently or in the near future.

Induced Pluripotent Stem Cells (IPSC), which are also a form of adult cell therapy, is not as far along in the pipeline. IPSCs are taken from your own skin cells. But they must then be transformed in the lab into the needed cell type. IPSC technology is rapidly moving forward but is still not available for most disease applications. Therefore, AACT is focused on therapies that can help patients now. These "man made" cells will be very expensive, while adult stem cells from your own body (autologous) are cost effective, making them more accessible to patients.

From an ethical perspective, AACT does not support the use of embryonic or fetal tissues. By remaining focused on adult stem cells, AACT negates the need for a patient having to choose between their health and their beliefs.

Q: I have arthritis and would like to try stem cell therapy to avoid knee replacement, Can AACT help me find a doctor?
A: AACT’s mission is to educate and provide awareness about stem cell therapies. AACT does not make referrals. However, AACT is currently in the process of developing patient education on the different types of therapies available in the US for arthritis so you, along with your physician, can make an informed decision.
Currently, there are many orthopedic clinics and sports clinics utilizing cellular therapy for those people who are good candidates for stem cell therapy as an alternative to knee replacement surgery. These protocols are less invasive, have significantly less recovery time, and may be less expensive. In some cases, insurance may pay for some elements of the procedure.

Q. Where can I find a clinical trial for my daughter who has Lupus?
A: AACT’s member section has a searchable clinical trial web page for specific diseases that connects with clnicaltrials.gov for both national and international trials.

Q. I have a friend who has experienced great relief from using her own stem cells for osteoarthritis. But I can't afford the cost. If stem cells work so well for so many conditions, why isn't every university hospital using them?
A. Unfortunately, the science of stem cells and their benefit for osteoarthritis has not spread completely through the medical community. This is one of the reasons AACT was formed. AACT provides scientific and medical education for medical professionals so as to impact access to stem cell therapies for patients. As collaborations are made and more workshops are completed around the US whether through AACT or other organizations, more doctors will offer these options to patients.
In the meantime, patients can ask their doctors about these new therapies. It has been proven that patients have an extreme amount of power to effect change, and it starts with patients asking their doctor for a treatment they have heard about.

Q. My father died recently of a heart attack. It runs in my family, so I've been researching stem cells. Does anyone at AACT know what the general medical consensus is today on using stem cells after heart attacks?
A:
As mentioned, I am not a doctor and cannot speak for the medical community or the medical consensus, but I can point you to Leslie Miller, MD who is an authority on cardiovascular disease and is on the Executive Board of AACT. He recently published what is considered the textbook on “Stem Cell and Gene Therapy for Cardiovascular Disease”.
At the AACT conference, Dr. Miller spoke about the fact that the heart is no longer considered “terminally differentiated”. In other words, it is now known that with cell therapy, the heart has an opportunity to improve. Fortunately, there are currently two (2) clinical trials for the heart that have entered the Phase III stage and, if approved by the FDA, will become commercialized. There are many more in Phase IIb, so the opportunity for patient access to cellular therapy for cardiovascular disease is on the horizon.

Q. I have a 7 year old son with type 1 diabetes. I was excited to see in the news that the AACT conference reported on using stem cells for this. How long will it be before my son can get this therapy?
A: AACT hosted international speakers who are conducting clinical trials in their country for Type I Diabetes with promising patient outcomes. It is my opinion that it will be about 5 years before children will have the opportunity to be treated with cellular therapies for diabetes unless they are enrolled in a clinical trial. AACT was established to advance and expedite cellular therapies to the clinic so that patients will have the opportunity to have a better quality of life.

Q. The University of Virginia School of Medicine published a report June 2015 that the brain has vessels that are part of the lymphatic system. If stem cells were injected into the lymph nodes, would this be another way to get stem cells past the blood brain barrier for neurologic conditions?
A:
As mentioned, I am not a doctor, but William Frey, II, Ph.D. and Lusine Danielyan, MD spoke at the AACT 2015 Conference about intranasal delivery of insulin and stem cells for neurologic and neurodegenerative conditions. Because the patented delivery system they developed is through the intranasal cavities, the cells go directly to the brain and do not affect the rest of the body. This is a tremendous benefit because the cells are placed exactly where they are needed in order to accomplish the purpose for which they were intended.

Q. Do you think insurance agencies will start to cover more of these procedures? Blue Cross/Blue Shield covers some very expensive stem cell transplants for CIPD and possibly MS, but it does so only in a few states from what I understand. It is doing so because a stem cell transplant is far cheaper than the annual cost of traditional pharmaceutical drug management of these diseases. There is ample evidence supporting the use of autologous bone marrow derived stem cells and orthobiologics, such as platelet rich plasma, for treating many orthopedic injuries. These alternative treatments are far cheaper, and usually far more efficacious than traditional invasive orthopedic surgeries which are not very effective at all, have little research demonstrating efficacy, and often have to be repeated once a decade; the traditional surgeries also result in long-term narcotic dependencies. It seems obvious that insurance would save a lot of money by covering these procedures. How can we get insurance to see the benefits of covering these procedures?
A.
This project is a long-term goal of AACT. An organization such as AACT can “act” on the behalf of the industry by working with insurance company statisticians and orthopedic doctors to create studies concerning cost effectiveness. Once studies such as these are completed, the insurance companies will most likely see the cost effectiveness of autologous treatments and make changes in their payment procedures.

Q. Big Pharma has a huge affect on politicians who can effect regulatory change. I don't see how any group or groups can cut through this massive hold that Big Pharma has to make the changes necessary for patients to be able to access treatments that are available and affordable. Big Pharma also has influence at universities, with the media, with doctors, etc. It seems a monumental (and next to impossible) task to cut through that influence. Unless there is a massive outcry by the public (which there isn't), how can AACT or any of us expect any change in the near future?
A.
Currently AACT is working with businesses, academics, physicians, professional societies and other stakeholders to collaborate as a group for this purpose. It is only through the collaboration of highly respected groups working in a collaborative manner to find a solution which all parties can accept that change will come about.

Q. I have COPD, the 3rd leading cause of death in the U.S. I am dumbfounded by the lack of interest in the research community for this disease. Research is poorly funded as compared to other diseases and most research concentrates on remakes of old drugs it seems. AACT was founded to advance therapies, so how can those in the COPD community help shine awareness on the lack of stem cell research for COPD/lung disease, especially as compared to other diseases that receive so much more attention and yet have far fewer afflicted?
A.
There are so many possibilities for an organization such as AACT to engage in in order to advance the industry as a whole. Tasks such as the one you mentioned will require volunteers to drive such an initiative. It has been shown, and the FDA along with other healthcare organizations recognize that patient involvement and patient advocacy drives change. AACT’s patient constituency is a platform to accomplish your mission, so I invite you to volunteer with AACT to assess the needs in this area, create a plan, and help AACT implement that plan to accomplish this purpose.

Q. I am frustrated at hearing news reports about stem cells only to realize that I don’t have access to the treatment spoken about in the media. What can I do to help AACT?
A
: There are many opportunities for you to help AACT accomplish its vision of “making regenerative medicine standard”. In addition to sharing information and spreading awareness about AACT on Facebook, please contact AACT for volunteer activities.
Anytime something new is presented, there are early adopters. Arnold Caplan, the “Father of the Mesenchymal Stem Cell” and a Keynote Speaker at the AACT 2015 Conference quoted Winston Churchill by saying that “We are at the end of the beginning.”
We are at the beginning of a new era of medicine. AACT invites you to join the organization and volunteer to raise awareness in your community. AACT is an alliance; many working together towards a common purpose. I believe that together we can make a difference and can find ways to expedite the process of taking the knowledge to the clinic so patients can benefit.
 
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