Cell-based interventions for neurologic conditions: ethical challenges for early human trials
D J H Mathews1, J Sugarman, H Bok
1Johns Hopkins University, 100 North Charles Street, Suite 740, Baltimore, MD 21201, USA. dmathews@jhmi.edu
Neurology
|May 9, 2008
Summary
Translating stem cell research into neurological treatments presents unique ethical challenges. Addressing these complex issues is crucial for responsible clinical translation and patient safety.
Area of Science:
- Neuroscience
- Cell Biology
- Bioethics
Background:
- Stem cell research is advancing towards clinical applications for neurological diseases and injuries.
- Early human clinical trials for cell-based neurological interventions are emerging in the US.
Purpose of the Study:
- To identify and deliberate on the scientific and ethical issues of transitioning cell-based interventions from preclinical to clinical research for neurological conditions.
- To address the ethical considerations of early human trials for stem cell-based neurological therapies.
Main Methods:
- Convened an interdisciplinary working group of experts in neuroscience, cell biology, bioethics, law, and transplantation.
- Deliberated over two years on scientific and ethical challenges in stem cell research for neurological conditions.
Main Results:
- Ethical issues in stem cell research for the central nervous system (CNS) are complex, amplified by novel science and the political climate.
- Standard human subjects research ethics are heightened by the unique challenges of CNS stem cell interventions.
Conclusions:
- Key challenges include evaluating trial risks, safety, benefits, cell line provenance, inclusion criteria, and informed consent.
- The ethics of conducting early human trials under public scrutiny require further stakeholder deliberation.
- Developing professional and institutional policies is necessary to govern stem cell research and early human trials.
