* Trial expected to start in early 2011
* StemCells expects to enroll about 12 patients
By Deena Beasley
LOS ANGELES, Nov 15 StemCells Inc STEM.O has
filed for Swiss regulatory approval for the first clinical
trial of its nerve stem cells in patients with spinal cord
injuries as much as a year old, the company said.
It expects to enroll about a dozen patients whose injuries
are between three and 12 months old.
"To date, the focus has been on the acute spinal cord
injury phase," StemCells CEO Martin McGlynn said in a telephone
interview. "That's an important area to address, but the
largest unmet need is those who have passed that immediate
acute phase of injury."
About 1.3 million Americans have chronic spinal cord
injuries, but most studies have shown that any treatment
attempt must take place within days after the injury to do any
StemCells Inc, based in Palo Alto, California, said the
relevant ethics committees have approved the trial, which it
plans to conduct in Switzerland due to the expertise of the
investigator and the institution it selected as well as the
strong network in Europe for spinal cord patients and
A study published earlier this year showed that mice
treated with StemCells' nerve stem cells -- which are extracted
from aborted fetuses -- were able to walk better than those
treated with ordinary human skin cells or a placebo, even when
the treatment came weeks after their injury.
The cells are a form of stem cell, the master cells of the
body. These are technically adult stem cells, taken from the
partly developed brains of fetuses and tested for qualities
showing they are destined to form particular types of nerve
Animal trials have shown that the cells migrate along the
spinal cord to the point of injury, and then differentiate into
neurons and specialized cells that create the insulation
necessary for proper transmission of nerve impulses from the
brain to below the level of the injury.
Patients in the StemCells trial will receive a single
infusion of cells into the spinal cord. Results are expected
within months of the treatment.
Geron Corp (GERN.O) last month launched the first trial of
human embryonic stem cells, but that study is in patients with
new spinal cord injuries. [ID:nN11175966]
Geron's stem cells come from human embryos left over from
fertility treatments. They have been manipulated so that they
have become precursors to certain types of nerve cells.
U.S. regulators took several years before granting final
clearance to the Geron trial. StemCells does not expect to have
to wait anywhere that long.
"There are a whole host of issues associated with the
embryonic stem cell platform," McGlynn said. "Thankfully our
neural stem cells don't have those safety concerns."
(Editing by Dhara Ranasinghe)