There is a researcher at the Sun Health Research Institute, Sun City, Arizona (can't remember his name) who is doing research using autologous adult stem cells.

It's been 2 years since I heard this Arizona researcher speak about using autologous adult stem cell treatment for PD. At that time, I asked him about Dr. Levesque's work, but he had never heard of Dr. Levesque or his research, which I found interesting.

Hello,
I went thru the paper published by Dr. L a couple of times last night. This is what I gathered and understood from it. Of course, data is data and can be interpreted in any way. Is the glass half full or half empty kind of scene!

The stem cells came from adult brain, so they are different from ES cells which is a good thing. They have less chances of turning into cancerous cells.
Then these cells were (I couldnt get the # of cells he obtained) grown in vitro for 9 months with factors. This is a very difficult task and I am impressed they could do that. My concerns would be after 9 months of being in culture, are they still "autologous"?
These cells are a mix of various types of cells including glial and variety of neurons; that might be the reason for success

It helped the patient for 3 years, and by 5 years the effect is gone.

This observation alone says lot about the potential of stem cell therapy.
Whatever mechanisms operating to destroy neurons in the first place are still operational and destroy newly implanted cells. The cure is not for life, and we need refills on a regular basis. I am not sure if that is a viable option.

I am optimistic about this line of therapy but also feel we are still a long way off from the cure for PD>

Girija

The full text of Dr. Levesque's article is now avaialable at:
http://www.neurogeneration.com/pdf/Levesque-MS.pdf

It was interesting to find in this article the planned trial design proposed for a phase II trial does not utilize sham surgery as a placebo control. Here's an example of alternative trial design. Will the FDA accept it?
Excerpt:

"Further refinement of the dosage, dose escalation, and a larger clinical trial is currently being planned to insure reproducibility of these findings. This next clinical trial will
consist of a prospective randomized controlled study and will compare best medical treatment to autologous neural stem cell therapy for advanced Parkinson’s disease. Selection criteria based on severity of the disease and genetic background will be among several other aspects that will be analyzed to provide statistically significant data after primary objectives are met."

http://www.neurogeneration.com/pdf/Levesque-MS.pdf

Although according to his web site this trial remains on "clinical hold".

Rayilyn Brown, a member of one of the other PD discussion groups - the Parkinsn List (or the Listserv) has been in email contact with Dennis Turner and Dr. Levesque and received some interesting replies to her questions about the adult stem cell treatment. As a way of spreading this information to others in the PD community Ray gave her permission to repost her messages on Neurotalk. You can also read them on the PIEN website:

Posted on Parkinsn’s list Feb 20, 2009
Subject : Dennis Turner Call
http://www.parkinsons-information-ex.../msg00313.html

“I just talked to Dennis today and he said he was not doing well at all. I asked him his opinion re the latest "breakthrough" and he didn't know anything about it.
He said he wasn't a doctor and would go with whatever Levesque said. We had a hell of a time talking as both our voices are bad and he seemed out of it, but that may be due to the voice problem. He is not aware of what has been going on the internet, although he did answer my email cc to him.

Ray

Rayilyn Brown
Director AZNPF
Arizona Chapter National Parkinson Foundation

Ray's email to Dr. Levesque and his reply:

Posted on parkinsn list Feb 21, 2009
Subject: re: Adult Stem Cell Treatment for Parkinson's
http://www.parkinsons-information-ex.../msg00325.html

“Dr. Levesque:

Thank you so much for taking the time to respond to my queries to Heather. I especially appreciate your clarification of your position regarding embryonic stem cell research as I certainly would not want to misrepresent your views regarding this controversial issue which I was unaware of until now. The fact that interests me is that Turner's PD returned about five years ago.

I assume you are aware that opponents of ESCR, like Steven Ertelt, J. Wesley Smith and David Prentice are using Turner's experience to make the case that ESCR is unnecessary since ASCR is so successful. As late as 2007 Senator Sam Brownback was presenting Turner as an example of an adult stem cell "cure". I called Turner yesterday and he told me he was not doing well. Although his reprieve is to be appreciated and your research should in no way be trivialized, it is not a cure and people are being led to think it is by these people and others on-line. I applaud your recent cautions that more
research is needed to validate Turner's temporary reversal of symptoms. But I have a big argument with David Prentice's 60-80 adult stem cell "cure" claims.

I do have a couple more questions:

How can the efficacy of the transplantation be accurately assessed if the subject still takes PD meds and sometimes has a neurotransmitter turned on? Even though as you explain Turner's DBS was not targeted for STN, doesn't it still qualify as a treatment? DBS is now being targeted to areas of the brain to alleviate clinical depression and epilepsy.
Why does my DBS exclude me from Phase II and Turner's was a part of his treatment package?

It seems to me that Turner's PD symptoms returned at least five years ago. His head was shaking in the 2004 video of his senate testimony. Why has the peer evaluation taken so long? Why now? The fact that his PD returned is never stated in the publicity surrounding Turner. What kind of difference would it make if it was?

DBS provides more than temporary reversal of tremor by stopping it cold, but folks debate its pros and cons rationally, and nobody calls it a "cure" or even a "successful treatment". Some people have had poor results with DBS while others got their lives back.

I just wish that all treatments for PD could be evaluated in the same way as DBS without regard to politics or religion. As a Parkinson's prisoner, I just want a cure and most of all the truth. I don't want any blocks on the road to a cure.

Rayilyn Brown
Director AZNPF
Arizona Chapter National Parkinson Foundation
rbrown@aznpf.org


From: Dr. Levesque
Sent: Friday, February 20, 2009 1:40 PM
To: rayilynlee@cox.net
Subject: RE: Adult Stem Cell Treatment for Parkinson's


Dear Rayilyn,



Thank you for your email and following our work. I would like to explain what makes our recent publication important in view of our current research efforts to treat Parkinson's disease. We did report on Mr Turner's initial outcome in 2002, but this current peer-reviewed publication (attached) presents the long term outcome (5 years post-op) and analyzes in detail several aspects of our methodology and clinical outcom. Mr Turner's initial harvesting was approved when a DBS electrode was inserted in the
thalamus back in 1998. This is not a subthalamic stimulator ( the STN as a target for Parkinson's disease was only approved in 2003, I think). A phase II study using the autologous neural stem cell approach was approved by the FDA in 2001, but the sponsor of the study changed and the FDA came with new regulations covering stem cell therapies (CFR21, part 210/211 and 1271). Our study is approved but is on "clinical hold" until we meet their new criteria. In addition, NeuroGeneration reacquired the technology
and Phase II study in 2005 and I will spare you the details of these additional delays.



As for potential patient like you who have been implanted with a DBS device, you would be excluded in the participation of the Phase II trial. We would eventually like to open the study to out of protocols patients if the FDA allows us to do so.



I would also like to clarify my position as a scientist without any political stance or affiliation. My team has worked with adult stem cells since 1996 and have advanced significantly in the comprehension of normal central nervous system development and in the pathophysiology of Parkinson's disease. We are not opposed to embryonic stem cells for research and cell therapy at all. If you read my testimony to the US senate, my position is quite clear. I am not misrepresenting our findings, please do not misrepresent my position if you do not know where I stand.

I remain available for any additional comments or question you may have,

Sincerely,

Michel F. Levesque, MD


Ray's first letter
From: rayilynlee [mailto:rayilynlee@cox.net]
Sent: Monday, February 16, 2009 9:16 PM
To: Heather Larrabee
Subject: Adult Stem Cell Treatment for Parkinson's


Heather:



As a person with Parkinson's disease for 13 years and a director of the Arizona Chapter of the National Parkinson Foundation, I have followed the outcome of Dennis Turner's treatment with his own stem cells for 6 years. In 2003 I contacted Dr. Levesque's office about the procedure and was steered to DBS. In 2003 I had 2 DBSs by Dr. Thomas Waltz at Scripps La Jolla. I moved from CA to AZ in late 2004. On March 24, 2006 I called Turner
to ascertain how he was doing. He told me his PD had returned with a vengeance. For some reason Levesque's Phase II never took place.



I was surprised to read today in the Bentham Open Stem Cell Journal about the adult stem cell breakthrough by Levesque and he was hoping for FDA approval of Phase II. What happened with Turner? I also understand that his stem cell procedure was done with a DBS operation. Since I have had DBS would that preclude my participation in a trial?"

I thanked Ray for taking the initiative to contact Dr. Levesque and clarifying his position. It appears both him and Dennis were exploited by David Prentice et al. But should the doctor have been more aware of the ramifications of his testifying at Sen. Brownback's hearing, and how it would be used politically? IMHO scientists should not claim ignorance about politics, as it afffects medical research funding and policy. It's their responsibility to learn about what is going on and to speak out when science is being compromised by politics, as has been the case for ESCR. Patients can help educate the researchers about these issues -- yet another reason for patients to be at the table.

Thanks Linda and to Rayilyn for sharing her emails. Now we have the facts straight from Dr. Levesque and his patient.

paula