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<SEC-DOCUMENT>0001299933-10-004085.txt : 20101116
<SEC-HEADER>0001299933-10-004085.hdr.sgml : 20101116
<ACCEPTANCE-DATETIME>20101115192814
ACCESSION NUMBER:		0001299933-10-004085
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20101115
ITEM INFORMATION:		Regulation FD Disclosure
FILED AS OF DATE:		20101116
DATE AS OF CHANGE:		20101115

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:		101194696

	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_39740.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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<FONT SIZE="5">
	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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	Date of Report (Date of Earliest Event Reported):
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	&nbsp;
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	November 15, 2010
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	StemCells, Inc.
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<BR>__________________________________________<BR>
	(Exact name of registrant as specified in its charter)
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	Delaware
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	000-19871
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	94-3078125
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_____________________<BR>
	(State or other jurisdiction
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_____________<BR>
	(Commission
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	(I.R.S. Employer
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	of incorporation)
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	File Number)
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	Identification No.)
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	3155 Porter Drive, Palo Alto, California
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	94304
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_________________________________<BR>
	(Address of principal executive offices)
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___________<BR>
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	Registrant&#146;s telephone number, including area code:
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	650.475.3100
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<FONT SIZE="2">
	Not Applicable
<BR>______________________________________________<BR>
	Former name or former address, if changed since last report
</FONT>
<P ALIGN="CENTER">
<FONT SIZE="2">
	&nbsp;
</FONT>
<!-- CoverPageRegistrant END --><P><FONT SIZE="2">
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions:</FONT>
</P>
<P><FONT SIZE="2">
[&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>
[&nbsp;&nbsp;]&nbsp;&nbsp;Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))<br>
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<B>
	Item 7.01 Regulation FD Disclosure.
</B>
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<FONT SIZE="2">
On November 15, 2010, StemCells, Inc. (the "Company") announced that is has filed an application with Swissmedic, the Swiss regulatory agency for therapeutic products, to conduct a clinical trial in Switzerland of the Company&#x2019;s HuCNS-SC&#174; purified human neural stem cells in chronic spinal cord injury patients. The full text of this press release is attached hereto as Exhibit 99.1.
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	SIGNATURES
</B>
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	Pursuant to the requirements of the Securities Exchange Act of 1934, the
	registrant has duly caused this report to be signed on its behalf by the
	undersigned hereunto duly authorized.
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	StemCells, Inc.
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<I>
	November 15, 2010
</I>
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	&nbsp;
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<I>
	By:
</I>
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<I>
	/s/ Kenneth Stratton
</I>
<BR>
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<I>
	Name: Kenneth Stratton
</I>
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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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	&nbsp;
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<FONT SIZE="2">
Press Release of StemCells, Inc. dated November 15, 2010
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<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>
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</TABLE>
</DIV>


<P align="center" style="font-size: 10pt"><FONT style="font-size: 11pt"><B>STEMCELLS, INC. FILES TO CONDUCT NEURAL STEM CELL TRIAL<BR>
IN CHRONIC SPINAL CORD INJURY</B></FONT>



<P align="left" style="font-size: 11pt; text-indent: 4%"><FONT style="font-size: 10pt"><B>PALO ALTO, Calif., November&nbsp;15, 2010 </B>&#150; StemCells, Inc. (NASDAQ: STEM) announced today
that is has filed an application with Swissmedic, the Swiss regulatory agency for therapeutic
products, to conduct a clinical trial in Switzerland of the Company&#146;s HuCNS-SC<sup>&#174;</sup> purified
human neural stem cells in chronic spinal cord injury patients. If authorized, the study would
enroll patients who are three to 12&nbsp;months post-injury.
</FONT>

<P align="left" style="font-size: 10pt; text-indent: 4%">&#147;With this filing we have taken a tangible step to broaden the clinical development of our
HuCNS-SC product candidate beyond the brain and into the spinal cord,&#148; said Martin McGlynn,
President and CEO of StemCells, Inc. &#147;This exciting initiative is supported by extensive
preclinical research demonstrating the ability of our proprietary cells to restore lost motor
function when transplanted in the chronic spinal cord injury setting. The prospect of extending
the treatment window to months or longer following injury would mean that a much larger population
of injured patients could potentially benefit from such an approach.&#148;


<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;Switzerland is home to some of the leading clinicians and medical centers in the world
engaged in the treatment and rehabilitation of spinal cord injury patients, which makes it an
excellent setting for this type of trial. While we have yet to secure Swissmedic authorization to
initiate the study, we are pleased to have already received approval from the respective ethics
committees at our anticipated trial site and the local Canton, both of which are prerequisites for
making a submission of this kind in Switzerland.&#148;


<P align="left" style="font-size: 10pt; text-indent: 4%">The results of numerous collaborative preclinical studies with researchers at the University
of California, Irvine (UCI)&nbsp;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%">Aileen Anderson, Ph.D., Associate Professor in the Departments of Physical Medicine and
Rehabilitation, and Anatomy and Neurobiology at UCI, commented, &#147;The preclinical data we have seen
to date provide a compelling rationale for advancing these neural stem cells into clinical testing
for chronic spinal cord 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. The demonstrated ability of these cells to repair an
injured spinal cord and promote functional motor recovery in animals could translate into improved
quality of life for individuals living with paralysis, and I am excited to see StemCells take this
important next step toward what I hope will one day become a viable therapy for a broad population
of spinal cord-injured patients.&#148;


<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 U.S. 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. StemCells hopes to address a broader
population of spinal cord-injured patients by opening the window of opportunity for therapeutic
intervention to months or longer post-injury.


<P align="left" style="font-size: 10pt; text-indent: 4%">More 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 Drs.&nbsp;Stephen Huhn and Aileen Anderson, as well as Irving Weissman,
MD, Chair of the Scientific Advisory Board and Director, StemCells, Inc.


<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
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.


<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 the treatment of two fatal neurodegenerative disorders in
children, and in preclinical development for spinal cord injury and 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 securing
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; and
other factors that are described under the heading &#147;Risk Factors&#148; in the Company&#146;s Annual Report on
Form&nbsp;10-K for the year ended December&nbsp;31, 2009, and in its subsequent reports on </I><I>Form 10-Q</I><I> and Form
8-K.</I>


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