Stem Cells 101: Uses and legal issues in the US

Update: It has been a long summer. I wish I could say I am seeing improvement but unfortunately that is not the case. I am hanging in there but my legs have gotten noticeably weaker over the last few months. I still do everything I can to manage. I have medicine that helps give me energy when I need it but generally my best time of day is the morning so that is when I am most productive and generally comfortable venturing out on my own. We still have hope stem cells might have an impact so I am currently planning a trip back to Panama in late February. I am always thankful for the continued support of Rich, my family, and friends.

A few months ago a doctor from Houston gave a presentation to our Lions Club on stem cell therapy, which is often referred to as regenerative medicine. I thought the presentation was very informative and pretty accurate regarding what I already knew about stem cells. But it raised some questions. Why can’t I receive stem cell treatment in the U.S. for MS? I know the type of treatment I have received is not being done in the U.S. but why? Is it illegal? There are stem cell clinics everywhere. What are the legal guidelines for stem cell use in the U.S.?

So I decided to do my own research and share some of the basic facts and information. Information about stem cells can be confusing so I’ll try to keep it basic.

Stem cells can be obtained from many tissue sites in the body, bone marrow, and blood. However the quality of the cells can vary. Stem cells can also be used from umbilical cord tissue and blood which is donated after birth. Embryonic cells are controversial because they come from tissue of an unborn embryo and have the potential to develop into any cell in the body. Their use and research is highly regulated and illegal in some states. My treatment consisted of donated umbilical cord tissue stem cells.

The truth is the FDA is having a hard time keeping up with the growing field of stem cells. Stem cell use is currently being studied for diabetes, heart disease, cancer, and many other conditions all across the world. The stem cell clinics in the United States are weakly monitored. The U.S. clinics typically focus on orthopedic problems such as pain, inflammation, and joint or soft tissue injury. There are some clinics claiming to treat a variety of conditions like heart disease, Parkinson’s disease, and autoimmune diseases such as MS.

Legal stem cell use

• Bone marrow and several cord blood products are the only approved stem cell products approved by the FDA. Cord blood is taken from the umbilical cord or placenta after child birth. According to the FDA, “Cord blood contains blood-forming (hematopoietic) stem cells that can be used in the treatment of patients with blood cancers such as leukemias and lymphomas, as well as certain disorders of the blood and immune systems.”

• There are no current treatments approved by the FDA using umbilical cord tissue stem cells. These are mesenchymal stem cells which have the potential to regenerate into a variety of tissue throughout the body.

• Under current U.S. regulations, stem cells can be removed from tissue in the body such as fat tissue, and re injected into the same person at the same location it was removed with minimal manipulation. This is commonly done for orthopedic conditions and pain relief.

Stem cell clinics

• There are over 500 stem cell clinics all across the U.S.

• The FDA recently set forth new regulations regarding stem cells but is waiting 3 years before they begin enforcing them.

• Most of these clinics have not been following FDA regulations. They’re doing more than minimal processing of the tissue before transplanting. They’re also putting the processed stem cells into locations other than the area where the tissue was removed.

• Many clinics are using stem cell products such as umbilical cord tissue cells even though they are not currently approved for treatment.

What does this mean? There seems to be clear evidence and plenty of patients who have benefited from stem cell treatment for orthopedic

ailments and pain. Some procedures may be covered by insurance and some doctors offer stem cell treatment in their office or medical practice. For the most part I believe stem cell therapy is harmless. In my opinion though, clinics offering treatments for diseases and other conditions in the US are probably not reliable unless they can provide detailed information and research regarding the conditions they are treating. I am not aware of any clinics in the US that do and would not trust them. There are even some in Houston. Stick to clinics that focus on tissue repair for things like injury, arthritis or pain.

The most important thing to consider when selecting a clinic is their professional practices. Do they have physicians on staff? Where do they get the stem cells and how are they processed? How long have they been in business? What conditions do they treat? What type of research can they provide on the condition you’re being treated for?

Personally, I do truly believe stem cell therapy has the potential to help heal many conditions. The research over the next decade will hopefully reveal a lot more about the benefits of stem cell therapy.

There is a therapy for MS that has been studied and proven to be relatively successful although with some risk called HSCT. According to the National Multiple Sclerosis Society, “HSCT (Hematopoietic Stem Cell Transplantation) attempts to “reboot” the immune system. Hematopoietic stem cells, which are derived from a person’s own bone marrow or blood, are collected and stored, and the rest of the individual’s immune cells are depleted by chemotherapy. Then the stored hematopoietic stem cells are reintroduced to the body. The new stem cells migrate to the bone marrow and over time produce new white blood cells. Eventually they repopulate the body with immune cells.”

Although there is no definitive number, some patients have gone into long term remission from MS symptoms after HSCT and others have seen improvement only to have symptoms reappear over time. There is a risk of toxicity and death from the chemotherapy agents used as well. Studies and trials have been conducted all over the world although different regimens have been used. Because the procedures and medicines used in HSCT are already approved by the FDA, you could see more clinics and doctors offering this treatment legally.

I am not considering HSCT because I believe the risks are too great for me. I would be excluded from most clinical trials because of my history of metastatic cancer. My body has been through a lot. I have already done chemotherapy and I’m not sure my body could handle the toxicity of this treatment.

All of my research has led me to believe I made the right decision to use the stem cell clinic in Panama. While I have said from the beginning there are no guarantees I will see improvement, the Stem Cell Institute of Panama has extensive experience and research on stem cell treatment for degenerative diseases. Neil Riordan, PA, PhD is the founder and has published numerous scientific articles on MS and many other conditions. His clinic team was formed in 2005 eventually moving to Panama in 2007. Specifically they are pioneers in using umbilical cord tissue stem cells. The cells they use are donated after birth and collected from local hospitals in Panama. Although they originally used mostly stem cells removed from fat tissue, their work has shown umbilical cord stem cells to be more effective for a variety of conditions including MS. It makes sense. Stem cells from our bodies are old. Stem cells from an umbilical cord are brand new and have not been pre-programmed giving them great potential to regenerate and restore diseased or injured tissue.

Do they make a profit? Of course they do but they also offer hope. And all of us faced with a life changing illness and limited or no options are looking for hope. It’s easy to get duped or taken advantage of. We are all looking for the “miracle” cure and there are plenty of empty promises out there ready to take our money.

But I believe some of those “miracle” cures do work for some people. I don’t look at it as a miracle but as finding what will work for your body. People do recover from conditions when they are told there is no hope, but not every diet, therapy, medicine or procedure works for every person.

So my strategy is to do my research and decide what feels right for me. I know I am taking my chances but I believe at this point it is my best option. I did it for cancer and now I’m doing it for MS. I know it is possible. I’ve met the proof. If all it costs is money we’re willing to take a chance that it will work for me. Maybe the US will catch up some day on their research but for now I’m thankful I have the means to travel to Panama.