u.s. doctors

[karl wagner]

I talked with a doctor today that said he could treat me in the u.s. using bone marrow stem cells. Does anyone know the laws or differences between the U. S. doctors and the companies we are all using over seas.

Karl

Treated 3/5/08

 

[barbara]

Unraveling the mystery

Karl - Some applications are legal in the U.S. Treatment for leukemia for instance has been going on for years. There are many cardiac trials and the clinic in Colorado is able to do treatment for orthopedic patients legally. I have no idea if the doctor you spoke to is offering to treat you for a disease that can be legally treated with stem cells. They are used for cancer treatment legally in the U.S. also. As for treatment for COPD such as I got, that is not a legal application at this time. It is very confusing, but you can bet on it that there would be an abundance of clinics if stem cell therapy was legal for all applications here in the U.S. Of course, if you are treated for something else (say arthritis at the Colorado clinic) and this treatment should prove to help your lungs or heart or whatever else ails you, then you have gotten a substantial bonus out of the orthopedic treatment. I hope others with a much vaster knowledge than me of how the FDA works will respond to your question.

 

[barbara]

Karl - Since there hasn't been anyone with an answer for you (Harv is out of town, Darn!), I am going to pass this question on to Dr. Ghen for the Ask the Doctor forum for April.

 

[barbara]

FDA mandates

Karl - I did find something that may be of interest in response to your question. It is in Steenblock and Payne's book, "Umbilical Cord Stem Cell Therapy". The following was taken from there:

Q. What is the current status of FDA approval for stem-cell treatments?

A. The FDA has not approved embryonic stem-cell treatments for any disease or condition. However, bone marrow and other sources of adult stem cells have been approved for about eighty-six diseases. And cord blood--but not pure umbilical-cord stem cells--is allowed by the FDA for certain hematopoietic diseases such as leukemia.
The National Institutes of Health (NIH) and private companies are funding research, but a great deal of the research is focused on working out the basic biology in lab animals, so progress is slow. And although several state governments have passed legislation to actively encourage stem-cell research, these laws do not mean that physicians in these states can give umbilical-cord blood or isolated stem cells to patients in need (outside of approved conditions or as part of government-sanctioned clinical trials). Federal law is supreme above state law, so even if a state were to pass a law permitting medical doctors and osteopathic physicians (D.O.) to give stem cells to their patients, this statue would surely be struck down at the federal level.

It goes on to state the the FDA has a legal mandate to protect medical consumer's health and welfare. Since embryonic stem-cell therapy is truly a "vast undiscovered country" in terms of efficacy and long term safety, the FDA is careful to enforce restrictions and regulations that keep it confined to the lab or the research center until it can be proven safe and effective. The Canadian Health Ministry has a similar policy The sad part is that this may be true for embryonic stem cells, but umbilical cord stems cells have been used for more than 40 years, they point out, with virtually no secondary illness or complications.

 

[steenblock]

bone marrow stem cells are legal in the USA

According to my very expensive FDA lawyer any licensed physician who has the knowledge to do so may give his or her patients bone marrow from the person's own body as long as it is given back to that same patient with only minimal manipulation. The problem is that advertising or making claims for this treatment as a method to treat a condition is considered to be making a drug claim and then that is illegal. I have been doing bone marrow transplants for patients for the last two years with no hassle from the authorities but I only talk about the results I have and do not make claims that this treatment will be helpful for any of your problems. The patient must sign forms indicating that it is experimental and that no claims for success have been made or implied by myself or my staff.

David Steenblock, DO

 

[JC the Fox]

I'm ready

Sign me up - where, when, how?

 

[barbara]

Welcome Dr. Steenblock

Thank you for your response to this question we have been kicking around for quite awhile. We are pleased that you have joined us on the forum. As for JC, you may contact Dr. Steenblock since he is now a member through this forum for more information. For those of you that don't know how to do this, click on members, then go to the appropriate first letter of the person you want to contact and you can send a private message there or an e-mail if the member signed up for e-mail messages.

 

[JC the Fox]

Making contact

Thanks, Barbara. I was just being anxious. I went to his website and then onto the bone marrow stem cell site, where I filled out the form requesting further information. In the meantime, I'm seeing if I can get donations for the expenses Since I do not wish to fly or go out of the states, this is the most exciting opportunity I've seen since I missed out on the Osiris trials.

 

[hlichten]

According to my very expensive FDA lawyer any licensed physician who has the knowledge to do so may give his or her patients bone marrow from the person's own body as long as it is given back to that same patient with only minimal manipulation. The problem is that advertising or making claims for this treatment as a method to treat a condition is considered to be making a drug claim and then that is illegal. I have been doing bone marrow transplants for patients for the last two years with no hassle from the authorities but I only talk about the results I have and do not make claims that this treatment will be helpful for any of your problems. The patient must sign forms indicating that it is experimental and that no claims for success have been made or implied by myself or my staff.

David Steenblock, DO

You are not permitted to isolate any cell types from the marrow, correct?
Are you permitted to do any laboratory counting of particular cell types before the re-injection? And, obviously, you can not call this a "stem cell treatment". We had understood that orthopedics provided the only "loophole" allowing marrow re-injection in the USA, but you are saying that any doctor can do this. If so, why is it not more commonly done?