WASHINGTON, Jan. 23 (Xinhua) -- The U.S. Food and
Drug Administration (FDA) has approved the first human trials of human embryonic
stem cell research, authorizing researchers to test whether the cells are safe
to use in spinal injury patients, U.S. biotech firm Geron Corp. announced
Friday.
The tests could begin by summer, said Dr. Thomas
Okarma, president and CEO of the Geron Corp. The trials will use human stem
cells authorized for research by then President George W. Bush in 2001. The
patients will be those with the most severe spinal cord injuries, called
complete spinal cord injuries.
The primary purpose of the trial will be to see
whether injecting these cells into patients is safe, but Okarma said researchers
will also look for any signs of recovery. Scientists will monitor the patients
for a year after the injections to see if they are regaining any function below
the injured point.
Whatever its outcome, the study will mark a new
chapter in the history of embryonic-stem-cell research in the United States -- a
field where debate spilled out of the laboratory long ago and into national
politics. While some overseas doctors claim to use human embryonic stem cells in
their clinics, stem-cell experts said they knew of no previous human studies
that use such cells.
The trials will involve eight to 10 patients who are
completely paralyzed below the third to 10th vertebra, and who sustained their
spinal cord injury within seven to 14 days. The tests will use stem cells
cultured from embryos left over in fertility clinics, which otherwise would have
been discarded.
Using the stem cells, researchers have developed
cells called oligodendrocytes, which are precursors to nerve cells and which
produce a protective layer around nerve cells known as myelin. Researchers will
inject these nerve cells directly into the part of the spine where the injury
occurred.
Embryonic stem cells are blank cells found in four-
to five-day-old embryos, which have the ability to turn into any cell in the
body. However, when stem cells are removed, the embryo is destroyed -- which has
made this one of the most controversial medical research fields in the past
decade.
Federal research funds were prohibited for embryonic
stem-cell research until August 2001, when Bush approved spending for research
using only already-existing cell lines. Scientists later discovered that fewer
than two dozen of those lines were useful for research, but abortion opponents
opposed any legislation that would lift Bush's restrictions, and Bush twice
vetoed congressional efforts to roll back his rules.
President Obama is expected to loosen the
restrictions, which many researchers and advocates have complained severely set
back work toward curing disease such as Alzheimer's, Parkinson's and diabetes.