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<SEC-DOCUMENT>0001299933-10-004369.txt : 20101209
<SEC-HEADER>0001299933-10-004369.hdr.sgml : 20101209
<ACCEPTANCE-DATETIME>20101208182333
ACCESSION NUMBER:		0001299933-10-004369
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20101207
ITEM INFORMATION:		Regulation FD Disclosure
FILED AS OF DATE:		20101209
DATE AS OF CHANGE:		20101208

FILER:

	COMPANY DATA:	
		COMPANY CONFORMED NAME:			STEMCELLS INC
		CENTRAL INDEX KEY:			0000883975
		STANDARD INDUSTRIAL CLASSIFICATION:	BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
		IRS NUMBER:				943078125
		STATE OF INCORPORATION:			DE
		FISCAL YEAR END:			1231

	FILING VALUES:
		FORM TYPE:		8-K
		SEC ACT:		1934 Act
		SEC FILE NUMBER:	000-19871
		FILM NUMBER:		101240845

	BUSINESS ADDRESS:	
		STREET 1:		3155 PORTER DRIVE
		STREET 2:		.
		CITY:			PALO ALTO
		STATE:			CA
		ZIP:			94304
		BUSINESS PHONE:		6504753100

	MAIL ADDRESS:	
		STREET 1:		3155 PORTER DRIVE
		STREET 2:		.
		CITY:			PALO ALTO
		STATE:			CA
		ZIP:			94304

	FORMER COMPANY:	
		FORMER CONFORMED NAME:	CYTOTHERAPEUTICS INC/DE
		DATE OF NAME CHANGE:	19930328
</SEC-HEADER>
<DOCUMENT>
<TYPE>8-K
<SEQUENCE>1
<FILENAME>htm_40020.htm
<DESCRIPTION>LIVE FILING
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<TITLE> StemCells, Inc. (Form: 8-K) </TITLE>
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		UNITED STATES<BR>
	SECURITIES AND EXCHANGE COMMISSION
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	WASHINGTON, D.C. 20549
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	FORM 8-K
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	CURRENT REPORT
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	Pursuant to Section&nbsp;13 or 15(d) of the Securities Exchange Act of 1934
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	December 7, 2010
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	StemCells, Inc.
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	Delaware
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	000-19871
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	94-3078125
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_____________________<BR>
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	3155 Porter Drive, Palo Alto, California
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	94304
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	650.475.3100
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	Not Applicable
<BR>______________________________________________<BR>
	Former name or former address, if changed since last report
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	&nbsp;
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Check the appropriate box below if the Form 8-K filing is intended to
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[&nbsp;&nbsp;]&nbsp;&nbsp;Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)<br>
[&nbsp;&nbsp;]&nbsp;&nbsp;Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)<br>
[&nbsp;&nbsp;]&nbsp;&nbsp;Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))<br>
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	Item 7.01 Regulation FD Disclosure.
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On December 7, 2010, StemCells, Inc. (the "Company") announced that it received authorization from Swissmedic, the Swiss regulatory agency for therapeutic products, to initiate a Phase I/II clinical trial in Switzerland of the Company&#x2019;s proprietary HuCNS-SC&#174; product candidate (purified human neural stem cells) in chronic spinal cord injury.  The full text of this press release is attached hereto as Exhibit 99.1.<br><br>
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	SIGNATURES
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	Pursuant to the requirements of the Securities Exchange Act of 1934, the
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	StemCells, Inc.
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	December 8, 2010
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	By:
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	/s/ Kenneth Stratton
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	Name: Kenneth Stratton
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	Title: General Counsel
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	Exhibit&nbsp;Index
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	Exhibit No.
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	Description
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	99.1
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Press Release of StemCells, Inc. dated December 7, 2010
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<BODY style="font-family: 'Times New Roman',Times,serif">


<P align="right" style="font-size: 10pt"><FONT style="font-size: 20pt">NEWS RELEASE</FONT>



<P align="left" style="font-size: 20pt"><FONT style="font-size: 12pt"><B><I>FOR IMMEDIATE RELEASE</I></B>
</FONT>
<DIV align="center">
<TABLE style="font-size: 12pt" cellspacing="0" border="0" cellpadding="0" width="95%">
<!-- Begin Table Head -->
<TR valign="bottom">
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    <TD width="5%">&nbsp;</TD>
    <TD width="49%">&nbsp;</TD>
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<!-- End Table Head -->
<!-- Begin Table Body -->
<TR valign="bottom" style="font-size: 12pt">
    <TD align="left" valign="top"><FONT style="font-size: 10pt"><B>CONTACT:</B></FONT>
</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top"><FONT style="font-size: 10pt">Investor Inquiries</FONT>
</TD>
    <TD>&nbsp;</TD>
    <TD valign="top"><DIV style="margin-left:0px; text-indent:-0px"><FONT style="font-size: 10pt">Media</FONT></DIV></TD>
</TR>
<TR style="font-size: 1px">
    <TD align="left" valign="top">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top" style="border-top: 1px solid #000000">&nbsp;
</TD>
    <TD>&nbsp;</TD>
    <TD valign="top" style="border-top: 1px solid #000000"><DIV style="margin-left:0px; text-indent:-0px">&nbsp;</DIV></TD>
</TR>
<TR valign="bottom" style="font-size: 10pt">
    <TD align="left" valign="top">&nbsp;</TD>
    <TD>&nbsp;</TD>
    <TD align="left" valign="top"><FONT style="font-size: 10pt">StemCells, Inc.<BR>
Megan Meloni<BR>
(650)&nbsp;475-3105</FONT>
</TD>
    <TD>&nbsp;</TD>
    <TD valign="top"><DIV style="margin-left:0px; text-indent:-0px"><FONT style="font-size: 10pt">Russo Partners<BR>
Ian Stone (619)&nbsp;528-2220<BR>
David Schull (212)&nbsp;845-4271</FONT></DIV></TD>
</TR>
<!-- End Table Body -->
</TABLE>
</DIV>


<P align="center" style="font-size: 10pt"><FONT style="font-size: 11pt"><B>STEMCELLS, INC. RECEIVES AUTHORIZATION TO CONDUCT<BR>
WORLD&#146;S FIRST NEURAL STEM CELL TRIAL IN SPINAL CORD INJURY</B></FONT>



<P align="left" style="font-size: 11pt; text-indent: 4%"><FONT style="font-size: 10pt"><B>PALO ALTO, Calif., December&nbsp;7, 2010 </B>&#150; StemCells, Inc. (NASDAQ: STEM) announced today that
is has received authorization from Swissmedic, the Swiss regulatory agency for therapeutic
products, to initiate a Phase I/II clinical trial in Switzerland of the Company&#146;s proprietary
HuCNS-SC<sup>&#174;</sup> product candidate (purified human neural stem cells) in chronic spinal cord
injury. The trial is designed to assess both safety and preliminary efficacy in patients with
varying degrees of paralysis who are three to 12&nbsp;months post-injury, and will progressively enroll
patients based upon the severity of injury. Enrollment is expected to begin in early 2011.
</FONT>

<P align="left" style="font-size: 10pt; text-indent: 4%">The trial will enroll 12 patients with thoracic (chest-level) spinal cord injury, and will
include both complete and incomplete injuries as classified by the American Spinal Injury
Association (ASIA)&nbsp;Impairment Scale. The first cohort will include patients classified as ASIA A.
These patients have what is considered to be a &#147;complete&#148; injury, or no movement or feeling below
the level of the injury. The second cohort will progress to patients classified as ASIA B, or
patients with some degree of feeling below the injury. The third cohort will consist of patients
classified as ASIA C, or patients with some degree of movement below the injury. In addition to
assessing safety, the trial will evaluate preliminary efficacy using defined clinical endpoints,
such as changes in sensation, motor, and bowel/bladder function.


<P align="left" style="font-size: 10pt; text-indent: 4%">&#147;This trial marks a significant broadening of our clinical development program,&#148; said Martin
McGlynn, President and CEO of StemCells, Inc. &#147;With this authorization, we will soon have three
active clinical trials evaluating our HuCNS-SC cells in conditions affecting both the brain and the
spinal cord. Our current clinical investigations now target lysosomal storage disease, myelination
disorders and central nervous system trauma.&#148;


<P align="left" style="font-size: 10pt; text-indent: 4%">The trial will be conducted in Zurich, Switzerland at the University Hospital Balgrist,
University of Zurich, one of the leading medical centers in the world for spinal cord injury and
rehabilitation. The principal investigator is Armin Curt, MD, Professor and Chairman, Spinal Cord
Injury Center at the University of Zurich, and Medical Director of the Paraplegic Center at the
University Hospital Balgrist. Dr.&nbsp;Curt is an internationally renowned medical expert in spinal
cord injury.


<P align="left" style="font-size: 10pt; text-indent: 4%">&#147;This trial represents a major advance for the field of spinal cord injury research as
effective treatments have yet to be developed for patients living with paralysis,&#148; stated Dr.&nbsp;Curt.
&#147;The use of neural stem cells to repair an injured spinal cord and restore function is a novel
therapeutic approach that I believe holds much promise. Neural stem cells are naturally suited to
render repair of the central nervous system, and therefore may prove to be an important strategy
for treating spinal cord trauma. I am very excited to be part of a groundbreaking study that could
pave the way for developing an effective therapy for this significant unmet medical need.&#148;


<P align="left" style="font-size: 10pt; text-indent: 4%">The results of numerous preclinical studies, conducted in collaboration with Drs.&nbsp;Aileen
Anderson and Brian Cummings at the University of California, Irvine (UCI), demonstrate the
significant therapeutic potential of the Company&#146;s human neural stem cells for the treatment of
spinal cord injury. Data published in several peer-reviewed journals show that the cells engraft,
migrate along the spinal cord to the point of injury, and then differentiate into neurons and
specialized cells called oligodendrocytes that create the insulation (myelin)&nbsp;necessary for proper
transmission of nerve impulses from the brain to below the level of injury. When transplanted in
spinal cord-injured mice at both sub-acute and chronic injury time points, the cells have been
shown to form protective myelin sheaths around damaged nerve axons and enable a significant and
persistent recovery of walking ability.


<P align="left" style="font-size: 10pt; text-indent: 4%">Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS program at StemCells, Inc.,
added, &#147;We feel privileged to be working with such a highly esteemed clinician as Dr.&nbsp;Curt as we
seek to develop a therapy with benefits similar to those shown in our preclinical studies.
Moreover, this trial design should enhance our ability to evaluate safety and efficacy in a
representative population of patients suffering from varying degrees of paralysis.&#148;


<P align="left" style="font-size: 10pt; text-indent: 4%">Additional information about the Company&#146;s spinal cord injury program can be found on the
StemCells, Inc. website at
<U>http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm</U>, including video
interviews with Company executives and independent collaborators.


<P align="left" style="font-size: 10pt"><B>More About the Trial</B>


<P align="left" style="font-size: 10pt; text-indent: 4%">Enrollment will be open to patients in Europe with thoracic spinal cord injury classified as
ASIA A, B or C, and with a neurological injury level of T2-T11. All patients will receive HuCNS-SC
cells through direct transplantation into the spinal cord, and will be temporarily
immunosuppressed. Following transplantation, the patients will be evaluated regularly over a
12-month period in order to monitor and evaluate the safety and tolerability of the HuCNS-SC cells,
the surgery and the immunosuppression, and to measure any recovery of neurological function below
the injury site. As the Company intends to follow the effects of this therapy long-term, a
separate four-year observational study will be initiated at the conclusion of this trial.


<P align="left" style="font-size: 10pt"><B>About Chronic Spinal Cord Injury</B>


<P align="left" style="font-size: 10pt; text-indent: 4%">According to a recent study initiated by the Christopher and Dana Reeve Foundation, nearly 1.3
million people in the United States alone are estimated to be living with chronic spinal cord
injury. Chronic spinal cord injury is characterized as a point in time after injury in which
inflammation has stabilized and behavioral recovery has reached a plateau. In spinal cord-injured
patients, the chronic phase typically does not set in until several weeks or months following the
injury. To date, treatment approaches have generally targeted the acute and sub-acute time points
post-injury, which are considered to be hours or days following injury. Restoring some degree of
function for patients at later time points beyond the acute injury phase could have a
transformative impact on the field as there are no effective treatment options for them today.
StemCells hopes to address a broad population of spinal cord-injured patients by opening the window
of opportunity for therapeutic intervention to months or longer post-injury, and by targeting a
wide range of injury levels and degrees of impairment.


<P align="left" style="font-size: 10pt"><B>About HuCNS-SC Cells</B>


<P align="left" style="font-size: 10pt; text-indent: 4%">StemCells&#146; lead product candidate, HuCNS-SC cells, is a highly purified composition of human
neural stem cells that are expanded and stored as banks of cells. The Company&#146;s preclinical
research has shown that HuCNS-SC cells can be directly transplanted in the central nervous system
(CNS)&nbsp;with no sign of tumor formation or adverse effects. Because the transplanted HuCNS-SC cells
have been shown to engraft and survive long-term, this suggests the possibility of a durable
clinical effect following a single transplantation. StemCells believes that HuCNS-SC cells may
have broad therapeutic application for many diseases and disorders of the CNS, and to date has
demonstrated human safety data from completed and ongoing studies of these cells in two fatal brain
disorders in children.


<P align="left" style="font-size: 10pt"><B>About StemCells, Inc.</B>


<P align="left" style="font-size: 10pt; text-indent: 4%">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. In its therapeutic
product development programs, StemCells is targeting disorders of the central nervous system and
the liver. StemCells&#146; lead product candidate, HuCNS-SC cells (purified human neural stem cells), is
currently in clinical development for spinal cord injury and the treatment of two fatal
neurodegenerative disorders in children, and in preclinical development for retinal disorders such
as age-related macular degeneration. StemCells also markets stem cell research products, including
media and reagents, under the SC Proven<sup>&#174; </sup>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 <U>www.stemcellsinc.com</U>.


<P align="left" style="font-size: 10pt; text-indent: 4%"><I>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 potential of the Company&#146;s HuCNS-SC product candidate to myelinate damaged nerve axons in
spinal cord injury patients and restore lost motor function; the potential of the Company&#146;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&#146;s current views and are based on certain assumptions that may or
may not ultimately prove valid. The Company&#146;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&#146;s HuCNS-SC cells for the treatment of any disease or disorder;
uncertainty as to whether the results of the Company&#146;s preclinical studies in spinal cord injury
will be replicated in humans; uncertainty as to whether the FDA or other applicable regulatory
agencies will permit the Company to continue clinical testing in PMD, NCL or in future clinical
trials of proposed therapies for other diseases or conditions given the novel and unproven nature
of the Company&#146;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&#146;s ability to recruit the patients required to conduct this
clinical trial or to obtain meaningful results; uncertainties regarding the Company&#146;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&#146;s cell-based programs will prove safe and clinically effective and not
cause tumors or other adverse side effects; uncertainties regarding the Company&#146;s ability to
commercialize a therapeutic product and its ability to successfully compete with other products on
the market; uncertainties regarding the Company&#146;s manufacturing capabilities given its increasing
preclinical and clinical commitments; and other factors that are described under the heading &#147;Risk
Factors&#148; in the Company&#146;s Annual Report on </I><I>Form 10-K</I><I> for the year ended December&nbsp;31, 2009, and in
its subsequent reports on </I><I>Form 10-Q</I><I> and </I><I>Form 8-K</I><I>.</I>


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