Alexion clinical trial on porcine olfactory ensheathing glia in chronic spinal cord injury

[Wise Young]

Alexion ( http://www.alexionpharm.com/index.cfm ) is a major pharmaceutical company that has been working with Jeff Kocsis at Yale University to develop a porcine source for olfactory ensheathing glial cell transplants. Several studies published by Kocsis and his colleagues at Yale have indicated that these cells promote regeneration and remyelination in the spinal cords of rats and monkeys. The company has provided press releases and also responded to inquiries from members of the community, indicating their intent to start a clinical trial in 2001 or 2002. Their web site describes their xenotransplantation program http://www.alexionpharm.com/techplat/index.cfm and specifically mentions spinal cord injury as one of their targets http://www.alexionpharm.com/products/index.cfm?pagename=unigraft but no clinical trial has been announced yet.

See posting by Joe of Slovakia (http://carecure.org/forum/showthread.php?t=13719) in the Cure Forum for more information.

[Wise Young]

http://www.eurekalert.org/pub_releases/1999-10/NC-YaAr-241099.php

[Chris Chappell]

Dr. Young,

From what I read about you and your labs work you seem to be very excited about the OEG potential. First question is why? Second question is if your theories are right then wouldn't it be smart of us to pursue a clinical trial such as Alexion or others involving OEG? Thanks.

Respectfully.

Chris http://sci.rutgers.edu/forum/images/smilies/confused.gif

[Wise Young]

Four different laboratories have now shown that olfactory ensheathing glial cells stimulate regeneration in the brain and spinal cord. These cells are believed to be responsible for the ability of the adult olfactory to regenerate continuously throughout adult life. The cells have several forms: bipolar, multipolar, and fried-egg. In the bipolar form, they are designed for migration, moving alongside growing axons, perhaps shielding the growth cones from inhibitory influences and "ushering" the axons to their destination. In the multipolar form, they are probably serving as guidance cells, expressing the cell adhesion molecule L1 and forming long processes along which axons prefer to grow. Finally, in the "fried-egg" mode, they look like a sunny-side up fried egg under the microscope. In this mode, they ensheath axons and myelinate them like Schwann cells. In fact, olfactory ensheathing glial cells have sometimes been called the Schwann cells of the central nervous system. However, they do much more and seem to be specialized to promote regeneration.

The other attractive aspect of these cells is that they are present in the olfactory nerve and bulb of adults. While it is possible to isolate these cells from the olfactory nerve and bulbs, and all of us have two bulbs and nerves, the surgery to take them out is not trivial. Several groups are currently developing the surgical approach to remove them as efficiently and as non-invasively as possible. But, because the olfactory bulbs are located at the base of the brain, the procedure will never be something that could be done in the office.

Alexion has developed porcine olfactory ensheathing glial cells that Jeff Kocsis and his group have shown to promote regeneration and remyelination in rats. The pigs have been genetically modified to be minimally immunogenic. These porcine olfactory ensheathing glial cells survive transplantation into monkeys and will remyelinated spinal axons. Of course, porcine cells are xenotransplants and therefore subject to the risks of xenotransplantation that we have discussed in another posting (http://carecure.org/forum/showthread.php?t=13842)

Wise.

[Chris Chappell]

Dr. Young. That information sounds very promising. When do you think this type of surgery / application could be available?

Is this, in your estimation, another piece of the healing puzzle?

Are there any human trials being considered?

Is this OEG research any more or less important than stem cells for example?

Thanks.

[Wise Young]

As pointed out above, Alexion has announced their intention to start a clinical trial using porcine olfactory ensheathing glial cells. The cells have been tested in a number of species, including monkeys. Several members of this forum have received email from the President of Alexion indicating the company's interest in starting clinical trials by 2002.

In the meantime, there are serious efforts underway at the Miami Project and also in Spain, developing surgical techniques to isolate the adult human olfactory bulb. A group in England reported last year that they were able to culture olfactory ensheathing glial cells from cadaver brains. And so, I believe that there may be a clinical trial involving adult olfactory glial cell autografts some day.

Finally, as indicated under the the topic of Samuil Rabinovich's surgical procedures (http://carecure.org/forum/showthread.php?t=39643), the group in Novosibirsk is apparently already implanting human olfactory ensheathing glial cells obtained from aborted fetuses into the spinal cord.

Wise.