More about Parkinson’s and stem cells….Keeping you posted as I learn too… The photo showing where damge occurs is from web MD (2002)
Would you be surprised that the technology to implant neural tissue in humans to alleviate Parkinson’s Disease was available as early as 2001 and in case studies has produced more successful remission than any drug on the market and with fewer side effects?
Michel F. Levesque, M.D., F.R.C.S.(C), F.A.C.S.Cedars-Sinai Medical Center in Los Angeles, Associate Clinical Professor of Neurosurgery at the UCLA School of Medicine, and member of the UCLA Brain Research Institute applied for Phase 11 FDA approval in several years ago. This was granted but sponsor complications and new rules by the FDA have put this phase on hold until Levesque and company can jump through the new hoops and negotiate more sponsors. This is tragic for Parkinson’s patients who could die or degenerate significantly before help is available.
It seems that the FDA would apply the same standard to our own cells that they do to foreign drugs. Pharmaceuticals take a ten year, 750,000 million dollar investment on average to bring to market and to start to make a profit. I do wonder about the stability of stem cell companies that have not counted the cost or prepared a strategy and stored up ammunition for battle. What did they think was going to happen? Nevertheless it makes one long for the days when scientists bit the bullet and practiced on themselves and family members. The results produced their own script. It seems today the trend is to scorn the establishment while begging to get into ‘the inner circle’. This cannot in all fairness be blamed on the FDA but rather on the inconsistencies of human nature and the need to belong. It is tragic that ethics and human decency for ‘the little people’ are tossed aside in the parade of blind ambition that ignores the simple concept that if you take away from the foundation (those that have supported your growth) the structure will destroy you…but I digress, on with the story….
It does seem strange that it is a woman’s ‘right’ to terminate a child but it is not an individual’s right to choose their own stem cells. The right to terminate brings death and is endorsed but the right to life through the harvesting of our own stem cells is denied by an outside source.
It is not like the FDA is even particularly good at culling out the problem children in the industry or adding to medical knowledge. A simple Google search on major drugs and problems in approved FDA pharmaceuticals is an eye opener in politics and commerce rather than the mainstream of patient safety for which they purport to represent.
Levesque and his colleagues did a successful case study with a man suffering from Parkinson’s in 2001 and yet in 2009 Parkinson’s patients are still dying needlessly. The FDA is still a bureaucracy which people are distracted into attacking while Scientists followed by the masses line up on the adult stem cell or embryonic bandwagon instead of putting partisan economics and politics aside to join together as scientists to promote healing and answers for those without hope.Here is a little about the study below:
“MATURE NEURONS DERIVED FROM THE PATIENT’S OWN BRAIN CAN BE TRANSPLANTED BACK SAFELY AND IMPROVE SYMPTOMSWe recently presented the clinical outcome of our autologous method at the International Congress of Parkinson’s disease and Movement Disorders in Rome. In accordance with our institutional review board, we transplanted a patient with advanced Parkinson’s disease with differentiated neurons derived from an initial needle biopsy. At three years post-operatively, the overall Unified Parkinson’s Disease Rating Scale (UPDRS) improved by 81% while “on” medication and 83% while “off” medication. We demonstrated here the long-term clinical remission of Parkinson’s disease symptoms in a single patient.Because of their biocompatibility, safety and potential integration into the host striatum, autologous adult neural stem cells and stem cell-derived neurons represent an effective alternative to current cell therapy aimed at the restoration of dopamine neuronal loss in Parkinson’s disease. Under the guidance and supervision of the Food and Drug Administration (FDA) office of Cellular, Tissues and Gene Therapies and the Center for Biologics Evaluation and Treatment (CBER) we are about to begin Phase II trials using this promising cell therapy.
CONCLUSION
Degenerative and traumatic disorders of the brain represent an enormous burden to the patient, their family and health care providers. The current debate between the embryonic stem cell proponents and those who are opposed to their use distracts from other avenues with promising outcome, such as adult stem cell therapy. It also overlooks other important issues of resource allocation between basic and clinical research, health insurance, and patient care. Scientific knowledge has rapidly progressed in the last five years (written in 2004) and stem cell research and therapy remains a very promising field for treatment of neurological disorders. In a recent biotechnology industry meeting, a presentation had the approximate title: “Businesses are from Mars, Academics are from Venus”. What was forgotten there is that patients are from planet Earth and this is what should guide our efforts “ (Levesque, 2004)For the complete story read here and for an update on where things are today check out this link
Love S et al., Glial cell line-derived neurotrophic factor induces neuronal sprouting in human brain, Nature
Medicine 11, 703-704, July 2005
Slevin JT et al., Improvement of bilateral motor functions in patients with Parkinson disease through the unilateral intraputaminal infusion of glial cell line-derived neurotrophic factor, Journal of
Neurosurgery 102, 216-222, February 2005
Gill SS et al.; “Direct brain infusion of glial cell line-derived neurotrophic factor in Parkinson disease”;
Nature Medicine 9, 589-595; May 2003 (published online 31 March 2003)
Would you be surprised that the technology to implant neural tissue in humans to alleviate Parkinson’s Disease was available as early as 2001 and in case studies has produced more successful remission than any drug on the market and with fewer side effects?
Michel F. Levesque, M.D., F.R.C.S.(C), F.A.C.S.Cedars-Sinai Medical Center in Los Angeles, Associate Clinical Professor of Neurosurgery at the UCLA School of Medicine, and member of the UCLA Brain Research Institute applied for Phase 11 FDA approval in several years ago. This was granted but sponsor complications and new rules by the FDA have put this phase on hold until Levesque and company can jump through the new hoops and negotiate more sponsors. This is tragic for Parkinson’s patients who could die or degenerate significantly before help is available.
It seems that the FDA would apply the same standard to our own cells that they do to foreign drugs. Pharmaceuticals take a ten year, 750,000 million dollar investment on average to bring to market and to start to make a profit. I do wonder about the stability of stem cell companies that have not counted the cost or prepared a strategy and stored up ammunition for battle. What did they think was going to happen? Nevertheless it makes one long for the days when scientists bit the bullet and practiced on themselves and family members. The results produced their own script. It seems today the trend is to scorn the establishment while begging to get into ‘the inner circle’. This cannot in all fairness be blamed on the FDA but rather on the inconsistencies of human nature and the need to belong. It is tragic that ethics and human decency for ‘the little people’ are tossed aside in the parade of blind ambition that ignores the simple concept that if you take away from the foundation (those that have supported your growth) the structure will destroy you…but I digress, on with the story….
It does seem strange that it is a woman’s ‘right’ to terminate a child but it is not an individual’s right to choose their own stem cells. The right to terminate brings death and is endorsed but the right to life through the harvesting of our own stem cells is denied by an outside source.
It is not like the FDA is even particularly good at culling out the problem children in the industry or adding to medical knowledge. A simple Google search on major drugs and problems in approved FDA pharmaceuticals is an eye opener in politics and commerce rather than the mainstream of patient safety for which they purport to represent.
Levesque and his colleagues did a successful case study with a man suffering from Parkinson’s in 2001 and yet in 2009 Parkinson’s patients are still dying needlessly. The FDA is still a bureaucracy which people are distracted into attacking while Scientists followed by the masses line up on the adult stem cell or embryonic bandwagon instead of putting partisan economics and politics aside to join together as scientists to promote healing and answers for those without hope.Here is a little about the study below:
“MATURE NEURONS DERIVED FROM THE PATIENT’S OWN BRAIN CAN BE TRANSPLANTED BACK SAFELY AND IMPROVE SYMPTOMSWe recently presented the clinical outcome of our autologous method at the International Congress of Parkinson’s disease and Movement Disorders in Rome. In accordance with our institutional review board, we transplanted a patient with advanced Parkinson’s disease with differentiated neurons derived from an initial needle biopsy. At three years post-operatively, the overall Unified Parkinson’s Disease Rating Scale (UPDRS) improved by 81% while “on” medication and 83% while “off” medication. We demonstrated here the long-term clinical remission of Parkinson’s disease symptoms in a single patient.Because of their biocompatibility, safety and potential integration into the host striatum, autologous adult neural stem cells and stem cell-derived neurons represent an effective alternative to current cell therapy aimed at the restoration of dopamine neuronal loss in Parkinson’s disease. Under the guidance and supervision of the Food and Drug Administration (FDA) office of Cellular, Tissues and Gene Therapies and the Center for Biologics Evaluation and Treatment (CBER) we are about to begin Phase II trials using this promising cell therapy.
CONCLUSION
Degenerative and traumatic disorders of the brain represent an enormous burden to the patient, their family and health care providers. The current debate between the embryonic stem cell proponents and those who are opposed to their use distracts from other avenues with promising outcome, such as adult stem cell therapy. It also overlooks other important issues of resource allocation between basic and clinical research, health insurance, and patient care. Scientific knowledge has rapidly progressed in the last five years (written in 2004) and stem cell research and therapy remains a very promising field for treatment of neurological disorders. In a recent biotechnology industry meeting, a presentation had the approximate title: “Businesses are from Mars, Academics are from Venus”. What was forgotten there is that patients are from planet Earth and this is what should guide our efforts “ (Levesque, 2004)For the complete story read here and for an update on where things are today check out this link
Love S et al., Glial cell line-derived neurotrophic factor induces neuronal sprouting in human brain, Nature
Medicine 11, 703-704, July 2005
Slevin JT et al., Improvement of bilateral motor functions in patients with Parkinson disease through the unilateral intraputaminal infusion of glial cell line-derived neurotrophic factor, Journal of
Neurosurgery 102, 216-222, February 2005
Gill SS et al.; “Direct brain infusion of glial cell line-derived neurotrophic factor in Parkinson disease”;
Nature Medicine 9, 589-595; May 2003 (published online 31 March 2003)
I will take your advice and refuse to allow others to define boundaries for me. I have my own mission and that is to create awareness for ASCTA (www.safestemcells.org, a grassroots organization started by doctors because the FDA declared our own stem cells to be drugs. There is a very troubling double standard being applied as fertility clinics are not being directed by the FDA to adhere to the same regulatory standards that the FDA is now imposing on doctors and clinics that treat patients with their own stem cells. The FDA has decided on its own, that any culturing of the cells (which is needed to make them clinically relevant in most cases)indicates that these cells are drugs. Clinics and doctors who want to treat patients with their own stem cells will be held to GMP guidelines even though half of these very guidelines make little sense when applied to stem cells. They will also need to file an IND for a new drug request. Fertility clinics which manipulate cells in their daily work are not being held to these same regulations. This makes one sniff the air and the odor is one of big pharma.
ReplyDeleteAs the co-founder of www.stemcellpioneers.com, the largest patient moderated forum for stem cell discussion and support for those who have had therapy and those thinking of having it, the reality of this nonsensical ruling is that many people will die because of it. They are too ill or do not have the money to travel outside the U.S. where such treatment has been available for several years now. ASCTA is promoting safe treatment and they have already written guidelines for physicians and labs that would have to be followed just like the fertility clinics do now. Last week on the Pioneer forum, we lost another member, for lack of available stem cell therapy. It was a senseless death of a wonderful lady and it wasn't the first since the forum began. I urge anyone reading this to join ASCTA and make your voice heard. Most legislators have no clue that the FDA is doing this. It must be stopped. The intertwining of a regulatory agency like the FDA and big pharmaceutical companies is disturbing to say the least. This grassroots effort by ASCTA could mean the difference between life and death for someone you know and care about. Barbara Hanson
Barbara,
ReplyDeleteThanks for being there for patients and creating a voice. As adult stem cells are accepted as the real form of treatment that they are costs will go down, the technology will be at a local level and affordable for those in need.
People are pioneering this technology at extensive cost to them selves and spending funds on FDA type mazes that could go for research and improved treatment protocols
Dr Amy
Dennis Turner, Dr. Levesque's patient, had his Parkinson's return over 4 years ago. I called him on 3-24-06 and recently 2-18-09 and he confirmed this fact. I don't consider this a "successful" treatment. I've had 2 DBS brain surgeries (Turner had one with the initial surgery and was on PD meds during treatment). We are far from a cure.
ReplyDeleteI would be interested in hearing more about this and from other patients. I am aware there is an initial antiinflammatory effect with the cells and that because PD is dopamine dependent the placebo effect is biological but temporary.
ReplyDeleteI am interested in all treatments that help PD....including DBS
I have seen several very successful orthopedic applications for stem cells and read with interest the cases in which stem cells were used to help with MS, however PD differs massively from these....
Dr Amy
It is absolutely beyond belief that the FDA can be allowed to hinder stem cell research and treatment in this way and not be made to explain or justify their reasons. Anonymous says that the patient's PD symptoms returned 4 years ago and we are far from a cure, however this gave the patient 3 or 4 years free of PD symptoms and delayed the advance by this long. There are many other conditions that stemcells may relieve, most of them causing constant pain and discomfort. The cost in lost wages, medical fees and quality of life must be added to the billions spent on pain relief. Drug treatments become less and less effective in time and bring their own range of health problems as sufferers increase their dose. This whole subject needs full investigation and open public debate.
ReplyDeleteThe anonymous commenter claims the PD returned four years ago and therfore does not regard stemcells as a successful treatment. Personally I would give anything for four symptom free days. The first 'sucessful' heart transplant was rejected after only one year. I expect many heart transplant patients are glad that neither anonymous nor the FDA had any say in whether transplant research continued.
ReplyDeleteI agree that some improvement is better than no improvement, but anonymous has a point in that the person treated was simultaneously treated with DBS and drugs....personally I see no problem with this as if the treatments he was on were satisfactory he would not have kept looking. I have however witnessed people spend money that could be used to extend comfort and care on treatments like ground up apricot seeds and juices with 'special' vitamins to treat staqe four cancer and watched them all die...I plan to do a blog on experimental treatment in the next few days
ReplyDelete