Resolving Ethical Issues in Stem Cell Clinical Trials: The Example of Parkinson Disease
Autor: | Bernard Lo, Lindsay Parham |
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Rok vydání: | 2010 |
Předmět: |
Research design
030506 rehabilitation medicine.medical_specialty Psychological intervention Alternative medicine MEDLINE Federal Government Patient Advocacy Placebos 03 medical and health sciences 0302 clinical medicine Informed consent Intervention (counseling) Humans Medicine Ethical Review Intensive care medicine Clinical Trials as Topic United States Food and Drug Administration business.industry Patient Selection Health Policy Parkinson Disease General Medicine United States Transplantation Clinical trial Issues ethics and legal aspects Research Design Government Regulation Safety 0305 other medical science business Ethical Analysis 030217 neurology & neurosurgery Stem Cell Transplantation |
Zdroj: | Journal of Law, Medicine & Ethics. 38:257-266 |
ISSN: | 1748-720X 1073-1105 |
DOI: | 10.1111/j.1748-720x.2010.00486.x |
Popis: | Stem cells derived from pluripotent cells offer the hope of new treatments for diseases for which current therapy is inadequate. Clinical trials are essential in developing effective and safe stem cell therapies and fulfilling this promise. However, such clinical trials raise ethical issues that are more complex than those raised in clinical trials using drugs, cord blood stem cells, or adult stem cells. Several clinical trials are now being carried out with stem cells derived from pluripotent cells, and many more can be expected in light of the rapid scientific progress in the field.Degenerative neurological diseases are desirable targets for stem cell clinical trials. The FDA has approved Phase 1 clinical trials of neural stem cell transplantation for Batten Disease, Pelizaeus-Merzbacher Disease, and spinal cord injury. In Parkinson Disease (PD), stem cell transplantation could correct the primary pathophysiological defect — inadequate levels of the neurotransmitter dopamine. Current treatment is unsatisfactory in late-stage PD. |
Databáze: | OpenAIRE |
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