DGAP-News: StemCells, Inc. Announces World–s First Neural Stem Cell Transplant in Spinal Cord Injury Patient

StemCells, Inc.

22.09.2011 15:00
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NEWARK, Calif., 2011-09-22 15:00 CEST (GLOBE NEWSWIRE) —
StemCells, Inc. (Nasdaq:STEM) announced today that the first patient in the
Company–s breakthrough Phase I/II clinical trial in chronic spinal cord injury
was successfully transplanted with the Company–s proprietary HuCNS-SC(r) adult
neural stem cells. The stem cells were administered yesterday at Balgrist
University Hospital, University of Zurich, a world leading medical center for
spinal cord injury and rehabilitation. The transplant surgery was performed by
a team of surgeons led by Dr. Raphael Guzman, a visiting staff neurosurgeon
also on faculty at Department of Neurosurgery, Stanford University, and Dr. K.
Min, an orthopedic surgeon at Balgrist University Hospital.

–I am pleased to be a part of this innovative clinical trial designed to help
us assess the safety and potential efficacy of HuCNS-SC stem cells for spinal
cord injury,– explains Dr. Armin Curt, Principal Investigator. –The preclinical
data underlying this trial provided compelling rationale to conduct a study of
this nature in spinal cord-injured patients.– StemCells, Inc. has published
numerous preclinical studies demonstrating the therapeutic potential of the
Company–s human neural stem cells for the treatment of acute and chronic spinal
cord injury. These studies were conducted in close collaboration with Drs.
Aileen Anderson and Brian Cummings of the University of California, Irvine.

The first patient transplanted in the trial, a 23-year-old German man, suffered
a spinal cord injury in an automobile accident in April of this year. He
sustained a complete loss of sensation and mobility from the waist down. When
asked about his decision to enroll in this leading-edge study, he said: –This
terrible injury crossed out almost all my life plans, and has led me to an
unexpected path. Participating in this clinical trial not only gives me a sense
of hope, but it also helps move this important research forward.–

–With this first patient enrolled and dosed, we remain on track to meet our
goal of treating the first cohort of patients by the end of this year,– said
Stephen Huhn MD, FACS, FAAP, Vice President and Head of the CNS Program at
StemCells, Inc. –While the trial–s first cohort will consist of patients with
the most severe, complete injury, the second and third cohorts will progress to
patients with less severe, incomplete injury. This unique trial design will
allow us to evaluate the potential of our HuCNS-SC cells as a treatment for a
broad spectrum of spinal cord injury patients. Even a small improvement could
have a marked impact on quality of life for the millions of people who suffer
from this debilitating condition.–

About the Clinical Trial

The Phase I/II clinical trial of StemCells, Inc.–s HuCNS-SC purified human
adult neural stem cells is designed to assess both safety and preliminary
efficacy. Twelve patients with thoracic (chest-level) neurological injuries at
the T2-T11 level are planned for enrollment. The first three patients will all
have injuries classified as ASIA A, in which there is no apparent neurological
function below the injury level, the most severe level identified by the
American Spinal Injury Association (ASIA) Impairment Scale. The second and
thirdcohorts will be patients classified as ASIA B and ASIA C, those with less
severe injury, in which there is some preservation of sensory or motor
function. In addition to assessing safety, the trial will assess preliminary
efficacy based on defined clinical endpoints, such as changes in sensation,
motor and bowel/bladder function.

All patients will receive HuCNS-SC cells through direct transplantation into
the spinal cord and will be temporarily immunosuppressed. Patients will be
evaluated regularly in the post-transplant period in order to monitor and
assess the safety of the HuCNS-SC cells, the surgery and the immunosuppression,
as well as to measure any recovery of neurological function below the injury
site. The Company intends to follow the effects of this therapy long-term, and
a separate 4-year observational study will be initiated at the conclusion of
this trial.

For information on patient enrollment, interested parties may contact the study
nurse either by phone at +41 44 386 39 01, or by email at
stemcells.pz@balgrist.ch.

Additional information about the Company–s spinal cord injury program can be
found on the StemCells, Inc. website at
http://www.stemcellsinc.com/Therapeutic-Programs/Clinical-Trials.htm and at
http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm,
including video interviews with Company executives and independent
collaborators.

About Chronic Spinal Cord Injury

According to a study reported by the Christopher and Dana Reeve Foundation,
nearly 1.3 million people in the United States are estimated to be living with
chronic spinal cord injury. The chronic phase of spinal cord injury is
considered to begin when inflammation has stabilized and recovery has reached a
plateau, which is typically several months following injury. Currently, there
are no effective treatment options for patients with chronic spinal cord
injury, and treatment approaches have generally targeted the acute and
sub-acute time points, which are within hours or days of injury. Given the
unmet need in chronic spinal cord injury, restoring some degree of function for
patients at time points beyond the acute phase could have a transformative
impact on the field. StemCells hopes to address a broad population of spinal
cord-injured patients by opening the window of opportunity for therapeutic
intervention well after the acute injury and targeting a wide range of injury
levels and degrees of impairment.

About Balgrist University Hospital

Balgrist University Hospital, University of Zurich is recognized worldwide as a
highly specialized center of excellence providing examination, treatment and
rehabilitation opportunities to patients with serious musculoskeletal
conditions. The clinic owes its leading international reputation to its unique
combination of specialized medical services. The hospital–s carefully-balanced,
interdisciplinary network brings together under one roof medical specialties
including orthopedics, paraplegiology, radiology, anesthesiology, rheumatology,
and physical medicine. More information about Balgrist University Hospital is
available at www.balgrist.ch.

About StemCells, Inc.

StemCells, Inc. is engaged in the research, development, and commercialization
of cell-based therapeutics and tools for use in stem cell-based research and
drug discovery. The Company–s lead therapeutic product candidate, HuCNS-SC(r)
cells (purified human neural stem cells), is currently in development as a
potential treatment for a broad range of central nervous system disorders.
Clinical trials are currently underway in spinal cord injury and in
Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children.
In addition, the Company plans to file an IND by year-end 2011 to initiate a
clinical trial of HuCNS-SC cells in the dry form of age-related macular
degeneration, and is also pursuing preclinical studies of its HuCNS-SC cells in
Alzheimer–s disease and stroke. StemCells also markets stem cell research
products including media and reagents, under the SC Proven(r) brand, and is
developing stem cell-based assay platforms for use in pharmaceutical research,
drug discovery and drug development. Further information about StemCells is
available at http://www.stemcellsinc.com.

The StemCells, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=7014

Apart from statements of historical fact, the text of this press release
constitutes forward-looking statements within the meaning of the Securities Act
of 1933, as amended, and the Securities Exchange Act of 1934, as amended, and
is subject to the safe harbors created therein. These statements include, but
are not limited to, statements regarding the prospect of retaining continued
authorization to conduct a clinical trial in Switzerland in chronic spinal cord
injury; the prospect and timing associated with enrolling the first cohort of
patients with complete injury in 2011, and then transitioning to patients with
incomplete injuries thereafter; the potential of the Company–s HuCNS-SC product
candidate to restore lost motor function; the potential of the Company–s
HuCNS-SC cells to treat spinal cord injury and other central nervous system
disorders; and the future business operations of the Company, including its
ability to conduct clinical trials as well as its other research and product
development efforts. These forward-looking statements speak only as of the date
of this news release. The Company does not undertake to update any of these
forward-looking statements to reflect events or circumstances that occur after
the date hereof. Such statements reflect management–s current views and are
based on certain assumptions that may or may not ultimately prove valid. The
Company–s actual results may vary materially from those contemplated in such
forward-looking statements due to risks and uncertainties to which the Company
is subject, including the fact that additional trials will be required to
demonstrate the safety and efficacy of the Company–s HuCNS-SC cells for the
treatment of any disease or disorder; uncertainty as to whether the FDA or
other applicable regulatory agencies will permit the Company to continue
clinical testing in PMD, spinal cord injury or in future clinical trials of
proposed therapies for other diseases or conditions given the novel and
unproven nature of the Company–s technologies; uncertainties regarding the
ability of preclinical research, including research in animal models, to
accurately predict success or failure in clinical trials; uncertainties
regarding the Company–s ability to recruit the patients required to conduct
this clinical trial or to obtain meaningful results; uncertainties regarding
the Company–s ability to obtain the increased capital resources needed to
continue its current and planned research and development operations;
uncertainty as to whether HuCNS-SC and any products that may be generated in
the future in the Company–s cell-based programs will prove safe and clinically
effective and not cause tumors or other adverse side effects; uncertainties
regarding the Company–s ability to commercialize a therapeutic product and its
ability to successfully compete with other products on the market; and other
factors that are described under the heading –Risk Factors– in the Company–s
Annual Report on Form 10-K for the year ended December 31, 2010, and in its
subsequent reports on Form 10-Q and Form 8-K.

CONTACT: Rodney Young
Chief Financial Officer
(510) 456-4128
News Source: NASDAQ OMX

22.09.2011 Dissemination of a Corporate News, transmitted by DGAP –
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.

DGAP–s Distribution Services include Regulatory Announcements,
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Language: English
Company: StemCells, Inc.

United States
Phone:
Fax:
E-mail:
Internet:
ISIN:US85857R1059
WKN:

End of Announcement DGAP News-Service

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