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<SEC-DOCUMENT>0001299933-11-000547.txt : 20110218
<SEC-HEADER>0001299933-11-000547.hdr.sgml : 20110218
<ACCEPTANCE-DATETIME>20110217195335
ACCESSION NUMBER:		0001299933-11-000547
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20110217
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20110218
DATE AS OF CHANGE:		20110217

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:		11622354

	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_40788.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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	Date of Report (Date of Earliest Event Reported):
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	February 17, 2011
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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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	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>
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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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<FONT SIZE="2">
	&nbsp;
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<!-- 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>
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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>
[&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 8.01 Other Events.
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<FONT SIZE="2">
On February 17, 2011, StemCells, Inc. announced that the fourth and final patient in its Phase I clinical trial in Pelizaeus-Merzbacher Disease (PMD) has been transplanted with the Company&#x2019;s HuCNS-SC&#174; cells (purified human neural stem cells).  The full text of this press release is attached hereto as Exhibit 99.1.
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	Item 9.01 Financial Statements and Exhibits.
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(d) Exhibits<br><br>Exhibit 99.1 Press Release of StemCells, Inc. dated February 17, 2011
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	SIGNATURES
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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
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	StemCells, Inc.
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	February 17, 2011
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	By:
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<I>
	/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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	&nbsp;
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Press Release of StemCells, Inc. dated February 17, 2011
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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. COMPLETES DOSING IN SECOND TRIAL OF<BR>
HUCNS-SC</B><sup><B>&#174;</sup> NEURAL STEM CELLS</B></FONT>



<P align="left" style="font-size: 11pt; text-indent: 4%"><FONT style="font-size: 10pt"><B>PALO ALTO, Calif., February&nbsp;17, 2011 </B>&#150; StemCells, Inc. (NASDAQ: STEM) today announced
that the fourth and final patient in its Phase I clinical trial in Pelizaeus-Merzbacher Disease
(PMD)&nbsp;has been transplanted with the Company&#146;s HuCNS-SC</FONT><FONT style="font-size: 11pt"><sup><B>&#174;</B></FONT><FONT style="font-size: 10pt"></sup> cells (purified human
neural stem cells). PMD is a fatal myelination disorder that afflicts male children. This
clinical trial, which is being conducted in collaboration with UCSF Benioff Children&#146;s Hospital, is
the first to evaluate neural stem cells as a potential treatment for a myelination disorder.
Results of the trial will be reported in early 2012.
</FONT>

<P align="left" style="font-size: 10pt; text-indent: 4%">Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS Program, said, &#147;Completing
enrollment in our second clinical trial of HuCNS-SC cells brings us one step closer to
understanding how our cell might offer clinical benefit for patients with serious neurological
conditions like PMD. We deeply appreciate the participation of the patients and their families in
this important clinical research, and are grateful to the expert team of investigators at UCSF for
helping us to advance the potential for neural stem cell therapy.


<P align="left" style="font-size: 10pt; text-indent: 4%">&#147;Between the Phase I Batten trial completed in 2009 and the PMD trial, we have dosed a total
of 10 patients. Both of these trials involved the transplantation of HuCNS-SC cells directly into
the brain at very high dose levels. The demonstrated feasibility of administering a significant
cell dose to multiple regions of the brain in a single surgery may be relevant to the treatment of
other neurodegenerative disorders.&#148;


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


<P align="left" style="font-size: 10pt; text-indent: 4%">The Phase I trial is designed to assess the safety and preliminary efficacy of HuCNS-SC cells
when transplanted in four patients with connatal PMD, the most severe form of the disease. Under
the trial protocol, each patient will be evaluated regularly over a 12-month period following
transplantation in order to monitor and evaluate the safety and tolerability of the HuCNS-SC cells,
the surgery, and nine months of immunosuppression. In addition, magnetic resonance imaging (MRI)
of the brain post-transplant may enable the measurement of new myelin formation. As the Company
intends to follow the effects of this therapy long-term, a separate four-year observational study
will be initiated upon completion of this trial. Additional information about this clinical trial
can be found at <U>http://neonatology.ucsf.edu/nbri/pmd-trial/</U> or by visiting
<U>www.stemcellsinc.com</U> or <U>www.clinicaltrials.gov</U>.


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


<P align="left" style="font-size: 10pt; text-indent: 4%">Patients with PMD are born with a defective gene, which leads to insufficient myelin in the
brain. Myelin is the substance that surrounds and insulates nerve cells&#146; communications fibers
(also known as axons). Without sufficient myelination, these fibers are unable to properly
transmit nerve impulses, leading to a progressive loss of neurological function. Those with the
most severe form of the disease, connatal PMD, lose the ability to walk and talk and eventually
die, often before the age of 10. Currently, there are no effective treatments for PMD.


<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; text-indent: 4%">Preclinical studies performed by StemCells and its collaborators provide a rationale for
potential therapeutic use of HuCNS-SC cells in myelination disorders. The Company has demonstrated
that, when transplanted into an animal model of hypomyelination (shiverer mouse), HuCNS-SC cells
engraft and differentiate into mature, specialized cells called oligodendrocytes, and form myelin
sheaths around host nerve fibers.


<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<sup>&#174;</sup> cells (purified human neural
stem cells), is currently in clinical development for spinal cord injury and 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>http://www.stemcellsinc.com</FONT><FONT style="font-size: 12pt"></U>.</FONT><FONT style="font-size: 10pt">
</FONT>

<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 potential of the
Company&#146;s therapies to treat PMD, Batten disease and other serious neurological disorders; the
potential of the Company&#146;s HuCNS-SC cells to myelinate host nerve fibers; the timing associated
with reporting the results of the PMD trial; 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 FDA or other applicable regulatory agencies will permit the Company to continue
clinical testing in PMD, Batten disease, 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&#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 obtain meaningful results based on the limited
number of patients enrolled; the fact that results obtained in any clinical trial in PMD may not be
predicative of results that would be obtained in regard to other myelination disorders;
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 </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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