Stem Cell Trials Attempt to Regrow Spinal Tissue
A clinical trial will soon be underway that will test how embryonic stem cells affect the regrowth of spinal cord tissues after injury. A meeting of a Food and Drug Administration advisory committee discussed stem-cell research issues before giving the study the green light. The panel consisted of 25 independent scientists and FDA researchers and discussed problems relating to proper stem-cell animal studies and how scientists can ensure proper differentiation of embryonic stem cells. There was some uncertainty about ensuring that stem cells don%u2019t become teratomas, or cancerous tumors that are formed by several different tissue types, such as muscle, bone, cartilage, and skin.
According to Jane Lebkowski, senior vice president of regenerative medicine at Geron Corp., claimed that there was much discussed in the range of topics on the table. Scientists had already begun implementing several ideas already. The FDA has been interested in studying the most effective ways of regulating stem-cell therapies. Thus far, tests on rats have revealed a marked improvement in injuries to the spinal cord after stem cells were injected at the injury site.
A study from as far back as 2005, published in the Journal of Neuroscience, found that giving rats injections of stem cells seven days after spinal cord trauma improved motor function. The clinical trial will test the safety of nerve stem cell injections into the spinal injury area in humans. Since 2001 President Bush has outlawed research on embryonic stem-cells. President Obama has since done away with that restriction, allowing for extensive clinical trials and continued progress in the field.
Additional research performed by a team of Keio University (Japan) researchers is examining optimal routes for transplanting neural stem cells in animal models of spinal cord injury. Thus far, intralesional injections have been found to confer more benefits when compared to intravenous and intrathecal injections.
For the study, researchers applied a new reporter gene, call ffLuc, for bioluminescence imaging in order to track the transplanted cells via MRI from injection site to spinal cord lesion. According to lead researcher, Dr. Masaya Nakamura, MRI signals from dead cells are not easily distinguishable from other living cells. In order to circumvent this obstacle, we have utilized a bioluminescence system that only tracks living cells.
After inducing spinal cord injury in mouse models, the researchers compared intralesional, intrathecal, and intravenous injection methods for safety and efficacy results when transplanting stem cells. Intralesional grafting emerged as the most successful method since animals receiving this method of injected showed the best survival rates for grafted cells after injection with no complications in the animals. Intrathecal injections showed low animal survival rates. Intravenous injections resulted in no grafted cells migrating from the spinal cord injury site; as a result many test animals died of pulmonary embolism shortly after injection.
Dr. Nakamura concluded that their findings indicate that the best overall method for stem cell transplantation into the injury site is via intralesional injection.
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