Autologous Stem Cells—Hope for the Future

by Barbara Hanson

12 June 2009

Barbara Hanson is cofounder of Stem Cell Pioneers, the largest patient-moderated forum for stem cell discussion and support for those who have had treatment and are considering it. Many different diseases are represented and ages range from very young children to octogenarians. She says, "We have one thing in common however, and that is that we are all seeking something that will help us or our loved ones find a cure or relief from the myriad of terminal and chronic diseases that the membership represents. The Pioneer forum represents hope." She speaks passionately of that hope and the FDA's attempts to...Well, I'll let her tell you:

If someone had told me 20 years ago that I would have a terminal lung disease that would disrupt my life and my family's as well, and that I would be spending every free moment trying to convince people that what my own government is doing is wrong, I'd have said they were crazy. You see, I believe that the FDA is out to eradicate millions of people just like me who are ill and considered end stage, which means that there is nothing else that one's doctor can do to change the result of the prognosis.

In my case, there is one more possible avenue—a lung transplant. I'm still young enough to qualify for the $300,000-400,000 operation, but the statistics do not seem that favorable for long term survival. There is also the daily dosage of 50 or more pills to prevent organ organ rejection, not to mention that even a slight cold might mean the end of the line. Quite frankly, this is horribly frightening to me, especially when there is so much promise of my own stem cells providing lung regeneration and a chance at life again.

A person’s own stem cells are called autologous adult stem cells (A-ASC). I have had 3 treatments using my own stem cells, and so far my disease has not progressed since the first one. In fact, my last pulmonary function test showed a 2% increase in lung function. I believe this to be quite an accomplishment for someone who had lost 5% the previous year. This doesn't take into account my energy level. I used to sit on the couch most of the day and night because any exertion caused painful and stressful shortness of breath. I have chronic obstructive pulmonary disease (COPD), the 4th leading cause of death in the U.S. I inevitably got every respiratory infection that came around, including several bouts of pneumonia. I was in bad shape.

In 2007, I saw a post on a COPD forum by a man who had tried A-ASC stem cell therapy. He was so enthusiastic, claiming it had saved his life. He was immediately thrown off the forum and there were denunciations of him as a con artist, snake oil salesman, flimflam man, etc. A few of us, however, wanted to hear more. The press didn't say much about stem cell treatments back then. It was a new frontier. So, we formed a small group, dubbed ourselves the Pioneers and tracked him down.

Nassin is world-traveling octogenarian diagnosed with COPD, the same condition I have. He now only needs to use supplemental oxygen at night. Recently, he took a driving trip through Israel and England, and he regularly flies Guatemala and El Salvador to visit relatives. He's a truly caring gentleman.

Learning From Experience

One of the group's ladies, Jeannine, found companies that provided A-ASC treatment in Argentina and Tijuana, Mexico. It was necessary to go outside the country because most stem cell treatment is not legal in the United States, no matter how ill a person is. (The FDA advises against this, apparently preferring we stay home and die.)

We both had umbilical cord stem cell treatment—or so we were told—on April 5, 2007 in Tijuana. The procedure was very simple—an IV drip in the arm. I literally collapsed upon getting the infusion. I thought I was being euthanized. She had no problems the day of treatment. The owner of the company said what happened to me was perfectly normal and all side effects did disappear within 30 minutes.

About one week after returning home, we both became very seriously ill. Jeannine was hospitalized for 8 days. I felt worse than I had ever felt with pneumonia. We thought we were going to die and even wanted to. We were babes in the woods back then, with no idea of what we were doing. There was no one to provide support for us. The company didn't return our calls. One kindly doctor who did the original consultation with us did come through. He believed it must have been a bug we picked up on our travels.

We actually did feel better once we recovered from the initial illness, and that improvement lasted for many months. To this day, we do not know what kind of cells were given to us. We were provided with no certificate of purity. We could have gotten animal cells for all we knew. We were babes in the woods. The company that gave us this treatment is now being sued by the kindly doctor who helped us. As it turned out, they weren’t following his protocols on most patients. There are other investigations of the CEO underway.

Why did we rush off to have this treatment, knowing little or nothing about it than what we were told by a salesman? We were desperate. We each have a terminal illness that left us with no real life. Currently, in the U.S. alone, it is estimated that over 110 million people suffer from some type of terminal or chronic condition that might benefit from stem cell treatment.

Helping Others Avoid Our Mistakes

After our recovery, we started the Stem Cell Pioneers, because we didn't want anyone else to have to go through what we did. We started to attract members and then slowly doctors, PhDs, nurses, researchers and other professionals joined us. This allowed us to add a popular feature called Ask the Doctor—sometimes changing to Ask the CEO or Ask the PhD—where members can ask professionals any question they wish. From our new associations with these truly remarkable individuals, Jeannine and I learned that what happened to us was not normal. Most agreed that we had gotten a very unsafe stem cell treatment of unknown origin.

I have done a lot of reading and listening to the professionals on the forum and others in the field of biotechnology, and no longer feel like a babe in the woods. Jeannine has graduated too. We were truly pioneers, albeit foolish ones, to do what we did, but that is where the real story begins.

Failures of Our Own Government

Our own government is not compassionate towards millions of its citizens. Although it may sound foolish to have run off to Tijuana and accepted such risky treatment, our alternative was certain death at a fairly early age. Both Jeannine and I are in our 50's.

Many people, including the media, seem to think that all stem cell research and treatment is based upon embryonic stem cells. This isn't true. President Bush, I believe, is responsible for years of lost research that has put the U.S. behind in many ways because of his role in vetoing embryonic stem cell research.

Partly because of the political brouhaha surrounding embryonic stem cell research, the public has never understood that there are different stem cell types. Indeed, just the other day, a reporter said that I must be happy since President Obama had lifted the restrictions on federal funding, so people could now get stem cell treatments. But in the U.S. that isn't true—they can't!

President Bush vetoed a bill that would have provided federal funding for embryonic stem cell research. At the veto ceremony, a couple dozen snowflake babies, created from unused fertility clinic embryos, were brought together with their adoptive parents. Groups behind creating snowflake babies receive federal grants from the Department of Health and Human Services, which according to Congresswoman Diana DeGette in her book, Sex, Science and Stem Cells, were over $10 million in 2006, about $77,000 per child. At the time President Bush vetoed the bill, 130 snowflake children had been born as a result of the program and your tax dollars. In 2006, it was estimated that over 400,000 unneeded embryos will ultimately be destroyed.

While money is being granted for this purpose, promising research for nonembryonic stem cells has gone unfunded by Congress. Eight long years—especially for those suffering from terminal diseases—have passed while federal funding has not been allowed for embryonic stem cellresearch.

Types of Stem Cells

Personally, I believe that both most pro-embryonic stem cell research politicians and the Christian Right have a narrow field of vision. They focus so much on this single type of stem cell that they overlook the potential of adult stem cell therapy. Umbilical cord stem cell treatments also offer great potential for many diseases. Both embryonic and umbilical cord stem cells are deserving of research and funding, but this will take time because they both involve using another person's cells to treat a patient. There is one stem cell treatment, however, that is available to all of us now and avoids any type of rejection—our own stem cells. Our bodies are full of stem cells. They circulate inside of us, helping to repair and regenerate when and where needed.

Many Cannot Afford or Travel to A-ASC Treatment

I have had 3 treatments using my own autologous adult stem cells. Because of the need to leave the country, it's been a great hardship traveling to the destinations where these treatments can be done. I must pay for all of my own treatment, though in contrast to a lung transplant, it's very reasonable. A-ASC treatments start at around $2000 and can range to well over $60,000. Variations depend on several factors, such as whether stem cells are delivered via catheterization or injection. Consider though that, if I'd had a lung transplant, my insurance would have paid for it and all the years of medications that come with it.

The desire to live is very strong and I do what I have to do. Unfortunately, many cannot. They are too ill to travel or simply do not have the money. I cannot let my good fortune leave these people behind. In April, we lost a dear lady on the Pioneer forum. She would have given anything to be able to have the stem cell treatments that might have saved her life, but she was simply too ill to travel. She is not the first one we've lost and undoubtedly won't be the last. In fact, I just received word today from a distraught husband whose wife died en route to treatment outside the U.S. The plane trip was simply too much for her. His words to me echo my own sentiments: The U.S. is responsible for her death.

The FDA Prevents A-ASC Treatment

I blame these deaths on the FDA. They have declared our own stem cells to be drugs if they are cultured, which is generally necessary to make the stem cells clinically relevant. As we age, there are fewer stem cells for harvest. Culturing allows the cells to grow to a number significant enough to treat a disease. One's own body provides stem cells to heal but cannot always provide enough stem cells to the right place at the right time. This is why culturing is so important.

Dr. Christopher Centeno, M.D. compares the current state of stem-cell medicine to that of fertility treatments. "If you're an infertility specialist, you have to grow a woman's fertilized oocytes at least to the blastocyst stage before implanting them, and the FDA has no control over that. If the FDA had gained control, you wouldn't have individual fertility practices—instead you'd have just a few big labs across the country." The reason the FDA didn't get control over the fertility clinics is simple, Dr. Centeno says. "They organized, put their own standards in place, and created a case, saying "Listen, this is the practice of medicine, and you, by charter, are not allowed to regulate the practice of medicine."

Why would the FDA want to do this? Personally, I believe, as do others, that one only needs to look at the cozy relationship between big pharmaceutical companies and the Food and Drug Administration. I don't see an all out conspiracy, but the two are so intertwined that I believe the problem is aggravated by the relationship. The FDA is like a slow moving turtle that is not keeping pace with what is needed to help terminally and chronically ill patients in this country. They are mired in conflicts of interest, stagnant policies, hints of corruption and the attitude that only the FDA knows best. The drug companies undoubtedly exert pressure as they are desperately trying to figure out a way to profit from A-ASC's.

For more information on how and why the FDA and USDA take such stands, see Codex Alimentarius (Part 1)—Evil as a Medieval Cabal and Codex Alimentarius (Part 2)—Food Defined As A Bunch of Chemicals.

The stakes are high. Legalizing treatment for orthopedic care alone could mean replacing $60 billion in drugs and device care with $6 billion in stem cell care, according to Dr. Centeno. Patients might actually get well and not need cradle-to-grave drugs. The FDA says that any doctor who cultures stem cells in any way has turned them into a drug. This requires doctors to file a new drug request, conduct endless clinical trials for all diseases to include all applications and follow good manufacturing practices, half of which currently make no sense with stem cell therapy.

We are at a crossroads today. The stakes are high, and not just in dollars. If Big Pharma controls our own stem cells via the FDA, innovation will slow to a crawl and costs will escalate. Millions of lives could be lost. Dr. Centeno founded American Stem Cell Therapy Association (ASCTA), which has developed strict guidelines and stem cell standards. Dr. Centeno explains that the group envisions "hundreds of people across the country doing this work (stem cell therapy) under the ASCTA Guidelines." Patients will have the benefit of selecting a doctor who is an ASCTA member. All members must follow the ASCTA Guidelines, which are very thorough. They include a Compassionate Use section for those who are in the end stages of their disease and have no other options. The Guidelines provide for safe treatment. They were put together by some of the best doctors and researchers in the stem cell community, who realize that A-ASC treatment is revolutionary and will change the way that medicine is practiced forever.

If the FDA continues as it is now, this revolutionary new medicine may forever be lost in the U.S. Therapies could become the exclusive domain of the pharmaceutical industry. This could mean 15-20 years before these treatments would be readily available to physicians. The cost in lives in this time period is nothing short of a catastrophe. There are already thousands of peer reviewed articles available and hundreds of animal model studies have been performed. ASCTA Guidelines are far more specific than the FDA's own guidelines because they are based on autologous stem cell therapy and not on drug regulation.

Carrying the Fight for Autologous Stem Cells Forward

ASCTA is a grassroots effort. I devote a great amount of my time to it, and am outraged that I have to beg for my life and for the lives of others who want to use their own stem cells to try to heal our disease-ridden bodies.

Some comments made in response to posts I've made on blogs and forums astound me. To the comments that the treatment might not be safe, I reply by asking how safe COPD (chronic obstructive pulmonary disease) or ALS (alateral sclerosis) or IPF (idiopathic pulmonary fibrosis) or any of the multitude of diseases that may treated with stem cells are. It's been pointed out that a small child developed a tumor after getting treatment in the Ukraine. This child had a strange concoction of fetal cells among other things, yet the same story is brought up in almost every negative response I get. The arguments are beginning to sound like a broken record.

The media often quotes treatments starting at $25,000.00. This is misleading. Most doctors base costs on what type of treatment is required. It isn't one size fits all. Reporters come up with some of the strangest arguments! "The FDA advises against anyone getting treatment outside the U.S." So? "Dr. Soandso does not have a graduate degree in stem cell medicine." How many do? Most work closely with researchers and collaborate with specialists. They also gather information from treatments performed in other countries. No reputable doctor promises cures. They say that stem cell treatment is in its infancy, and the patient is made well aware of that. Many still practice conventional medicine in the U.S. while providing A-ASC treatments outside its borders. They are doctors who are denied the ability to treat many patients with in the manner they feel is best.

Big Pharma must have an army of people out there who simply do not understand that this is not something that I, or any others I know, are going to be scared out of doing. I can't believe the average Joe would be fighting this issue, so it must be the big boys doing the dirty deed.

I do not deny that there are disreputable doctors and companies, but instead of trying to negate all stem cell therapy, ferret these out and report on them. The industry itself does not deserve the condemnation.

In my view, people are being bombarded with so much misinformation that they want to tell me what I should do with my life and what choices I should make. People who need stem cell treatment want it to be safe, done in the U.S. by physicians near where we live, and we want it now. We do not want to have to travel outside the country. The good doctors I know who treat outside the U.S. do so only out of necessity, because it is illegal to do so inside the country. These doctors are not rogues or quacks, as some would like to insinuate, but are caring and able to practice medicine using a remarkable set of tools: A-ASC's. What happened to Jeannine and me should not happen to anyone, yet the FDA's poor judgment continues to force desperately ill patients to seek treatment wherever they can get it.

I would like to encourage everyone to join ASCTA, . which also offers a website for doctors. We must act quickly by contacting the FDA, legislators and the media. Sample letters are available on the ASCTA site.

We are in a real battle in this country. We can sit by and do nothing or we can actively participate in the future of stem cell medicine. I do not want a life full of drugs and surgeries for myself or my child or grandchildren. I don't want my future dictated by an uncaring government agency, lobbyists, the media or pharmaceutical companies. I want to be able to determine with my own physician what is right for me, and one of the choices I insist upon is treatment with my own stem cells. I also am an advocate for research using other types of stem cells, but A-ASC is right for me and years ahead of other therapies in terms of safety and research.

Join ASCTA today!