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)
