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<SEC-DOCUMENT>0001299933-10-003641.txt : 20101007
<SEC-HEADER>0001299933-10-003641.hdr.sgml : 20101007
<ACCEPTANCE-DATETIME>20101007165256
ACCESSION NUMBER:		0001299933-10-003641
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20101007
ITEM INFORMATION:		Other Events
FILED AS OF DATE:		20101007
DATE AS OF CHANGE:		20101007

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:		101114347

	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_39289.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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	October 7, 2010
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	StemCells, Inc.
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	(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>
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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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	(Address of principal executive offices)
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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
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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 October 7, 2010, StemCells, Inc. reported progress in its Phase I clinical trial in Pelizaeus-Merzbacher Disease.  The full text of this press release is attached hereto as Exhibit 99.1.
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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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<I>
	October 7, 2010
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<I>
	By:
</I>
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<I>
	/s/ Kenneth Stratton
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<BR>
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<I>
	Name: Kenneth Stratton
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<I>
	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 October 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="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. REPORTS PROGRESS IN MYELINATION DISORDER TRIAL</B></FONT>



<P align="left" style="font-size: 11pt; text-indent: 4%"><FONT style="font-size: 10pt"><B>PALO ALTO, Calif., October&nbsp;7, 2010 </B>&#150; StemCells, Inc. (NASDAQ: STEM) today provided an
update on its ongoing Phase I clinical trial in Pelizaeus-Merzbacher Disease (PMD), a fatal
myelination disorder that afflicts male children. Two of four planned patients for this trial have
now been enrolled and 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> human neural
stem cells. The Company anticipates enrolling a third patient before year-end and the fourth
shortly thereafter. This clinical trial is the first to evaluate purified neural stem cells as a
potential treatment for a myelination disorder. The trial is being conducted at UCSF Benioff
Children&#146;s Hospital.
</FONT>

<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.,
said, &#147;We are very pleased with the progress to date and I am happy to report that the first
patient dosed in this trial is now eight months post-transplant, and is continuing to be observed
through regularly scheduled follow-up evaluations at UCSF. We continue to be encouraged by the
growing body of safety data we are accumulating for our HuCNS-SC cells, which is particularly
meaningful considering both the substantial cell dose and the fact that the cells are being
directly transplanted into the brain. Together with the broad therapeutic potential demonstrated
in our preclinical studies, we believe our HuCNS-SC cells could have applicability to a range of
other disorders where myelination plays a key role such as multiple sclerosis, transverse myelitis,
certain types of cerebral palsy and spinal cord injury.&#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 effectiveness of HuCNS-SC
cells as a potential treatment for PMD. The trial is expected to enroll four patients with
connatal PMD. All patients will be transplanted with HuCNS-SC cells, and will be immunosuppressed
for nine months. 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. In addition, magnetic resonance imaging (MRI)&nbsp;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 at the conclusion of this trial. Interested parties may find more information on patient
enrollment at <U>http://neonatology.ucsf.edu/nbri/pmd-trial/</U> or by visiting
<U>www.stemcellsinc.com</U>. Additional information about this clinical trial can also be found
at <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.
The transplanted cells are able to engraft, migrate, differentiate into neurons and glial cells,
and possess the ability to survive long term 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; 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; text-indent: 4%">StemCells has completed a Phase I clinical trial of its HuCNS-SC cells for the treatment of
Neuronal Ceroid Lipofuscinosis (NCL, also often referred to as Batten disease), a fatal brain
disorder in children. Data from this trial demonstrated the clinical safety and tolerability of
these cells. The Company plans to initiate a second clinical trial in NCL during the fourth
quarter of 2010. HuCNS-SC cells are also in preclinical development for other central nervous
system disorders, including spinal cord injury and age-related macular degeneration. The Company
is working toward initiating clinical trials in both of these conditions in 2011 and 2012,
respectively.


<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 stem cell
therapeutics and tools for use in stem cell-based research and drug discovery. In its therapeutic
product development programs, StemCells is targeting diseases of the central nervous system and
liver. StemCells&#146; lead product candidate, HuCNS-SC<sup>&#174;</sup> cells (purified human neural stem
cells), is in clinical development for the treatment of two fatal neurodegenerative disorders that
primarily affect young children. StemCells also markets specialty cell culture products 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 potential of the
Company&#146;s therapies to treat PMD, NCL and other serious neurodegenerative diseases; the prospects
and timing associated with completing patient enrollment in the Company&#146;s ongoing clinical trials;
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; 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 based
on the limited number of patients expected to be 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
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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