Stem cell clinical trial for Parkinson's begins

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Pioneer Founding member
Australian trial uses brain cells created from unfertilized human egg cells
Bradley J. FikesMarch 7, 2016

http://www.sandiegouniontribune.com/...-trial-begins/

In what appears to be a first for Parkinson’s disease therapy, patients are now being recruited for an Australian clinical trial of a stem-cell based therapy from Carlsbad’s International Stem Cell Corp.

The Phase I trial, conducted by the company's Cyto Therapeutics subsidiary, seeks signs of safety and early evidence of efficacy. Announced Monday, it aims to relieve the movement disorders of Parkinson's by replacing the kind of brain cells destroyed in the disease. These cells produce the neurotransmitter dopamine, which enables normal movement.

The stem cell trial appears to be the first to begin recruiting clinical subjects for Parkinson's treatment, said Kevin McCormack, a spokesman for the California Institute for Regenerative Medicine, the state's stem cell agency. Similar studies were performed decades ago using fetal brain cells, but these ended with mixed results.

For more information, visit j.mp/iscostudy.

The trial also represents a milestone for International Stem Cell, which for years has been developing its own kind of stem cells. These are created from parthenogenetic, or unfertilized human egg cells, and are engineered to make them less likely to cause an immune reaction. But while ISCO has made research progress with these cells, they have not been placed into therapeutic use until now.

Another trial using a different stem cell approach is in the planning stage by a San Diego-based coalition of researchers and patients called Summit for Stem Cell. This one is to use artificial embryonic stem cells as a source of the replacement brain cells. Called induced pluripotent stem cells, these can be grown from skin cells. Another trial using IPS cells is being readied in Japan.

Under the ISCO study, 12 people with moderate to severe Parkinson's disease will be treated at Royal Melbourne Hospital in Melbourne. They will be given one of three doses of cells, from 30 million to 70 million. They will be monitored for 12 months to evaluate the safety and activity of these cells.

The patients will be assessed before receiving the treatment under standards such as the Unified Parkinson's Disease Rating Scale, and will be reassessed at intervals.

ISCO says parthenogenetic stem cells act much like embryonic stem cells, but their use avoids the moral objections of those opposed to the use of those cells. Since they are derived from human embryos killed to get the cells, many of those opposed to abortion say their use is wrong.

The Roman Catholic Church is skeptical of parthenogenetic stem cell research. The moral status of the cells is unclear and might be equivalent to a human embryo, Rev. Tadeusz Pacholczyk, Director of Education for The National Catholic Bioethics Center, said by email Monday.

To avoid taking human life, the embryo-like structure created through parthenogenesis should be given the benefit of the doubt and considered a human being, Pacholczyk said. By this standard, the use of parthenogenetic cells to help someone else would be morally wrong. However, the church has not unambiguously condemned the use of these cells to the same degree as it has with embryonic stem cells.
 
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