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<SEC-DOCUMENT>0001299933-10-003855.txt : 20101028
<SEC-HEADER>0001299933-10-003855.hdr.sgml : 20101028
<ACCEPTANCE-DATETIME>20101028171229
ACCESSION NUMBER:		0001299933-10-003855
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20101028
ITEM INFORMATION:		Other Events
FILED AS OF DATE:		20101028
DATE AS OF CHANGE:		20101028

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:		101148919

	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
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<FILENAME>htm_39504.htm
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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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	October 28, 2010
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	StemCells, Inc.
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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>
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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>
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	Item 8.01 Other Events.
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<FONT SIZE="2">
On October 28, 2010, StemCells, Inc. announced that it has initiated a second clinical trial of its HuCNS-SC&#174; product candidate (purified human neural stem cells) in neuronal ceroid lipofuscinosis (NCL, also often referred to as Batten disease). The full text of this press release is attached hereto as Exhibit 99.1.
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	StemCells, Inc.
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	October 28, 2010
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	By:
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	/s/ Kenneth Stratton
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<I>
	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 October 28, 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>
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    <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. ADVANCES TO SECOND CLINICAL TRIAL IN BATTEN DISEASE</B></FONT>



<P align="left" style="font-size: 11pt; text-indent: 4%"><FONT style="font-size: 10pt"><B>PALO ALTO, Calif., October&nbsp;28, 2010 </B>&#150; StemCells, Inc. (NASDAQ: STEM) announced today that
it has initiated a second clinical trial of its HuCNS-SC<sup>&#174;</sup> product candidate (purified
human neural stem cells) in neuronal ceroid lipofuscinosis (NCL, also often referred to as Batten
disease), a fatal neurodegenerative disorder in children. The trial is designed to evaluate the
safety and preliminary efficacy of the cells in patients with either infantile or late infantile
NCL. The trial will enroll six patients with less advanced stages of the disease than those who
participated in the Company&#146;s first NCL trial. Like the first NCL trial, this second trial is
being conducted at Oregon Health & Science University (OHSU)&nbsp;Doernbecher Children&#146;s Hospital, a
leading medical center with nationally recognized programs in pediatric neurology and neurosurgery.
</FONT>

<P align="left" style="font-size: 10pt; text-indent: 4%">&#147;The initiation of this trial represents a key advancement in the evaluation of our human
neural stem cells as a potential therapeutic product,&#148; said Stephen Huhn, MD, FACS, FAAP, Vice
President and Head of the CNS Program at StemCells, Inc. &#147;In this second trial, we will continue
to assess safety, but will also look at certain measurements to evaluate the impact of these cells
on disease progression. The trial is designed to enroll patients with less neuronal degeneration,
which we believe will enhance the prospect of detecting clinical benefit. The data gathered from
this trial will also help us begin to assess possible clinical endpoints for use in a pivotal
clinical trial in NCL, and may provide important information about the potential for the use of
these cells in other neurodegenerative disorders.&#148;


<P align="left" style="font-size: 10pt; text-indent: 4%">The trial is being led by Nathan Selden, MD, PhD, FACS, FAAP, Campagna Professor of Pediatric
Neurosurgery and head of the Division of Pediatric Neurological Surgery at OHSU Doernbecher
Children&#146;s Hospital and OHSU School of Medicine. Dr.&nbsp;Selden was co-principal investigator of the
Company&#146;s first NCL trial.


<P align="left" style="font-size: 10pt; text-indent: 4%">&#147;We are pleased to work with StemCells in the pursuit of an effective therapy for this
devastating disease,&#148; stated Dr.&nbsp;Selden. &#147;The first study conducted here at OHSU Doernbecher
Children&#146;s Hospital revealed a favorable safety profile for human neural stem cell transplantation
directly into the brain. This second trial is an important next step, and may allow us to see
evidence of clinical efficacy from the transplanted cells. We look forward to further evaluating
the potential of these cells to truly help children facing a desperate illness.&#148;


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


<P align="left" style="font-size: 10pt; text-indent: 4%">The Phase Ib trial is designed to further assess the safety and preliminary efficacy of
HuCNS-SC cells as a potential treatment for NCL. All patients will be transplanted with HuCNS-SC
cells via a neurosurgical procedure, 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, MRI evaluations will focus on potential measures of effect from
the donor cells, including assessing and tracking cerebral volume and unique neuronal metabolites,
both of which are negatively impacted by disease progression. 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. For information on patient enrollment, interested parties may
call</FONT><FONT style="font-size: 12pt"> (</FONT><FONT style="font-size: 10pt">503) 418-4495. Additional information about this clinical trial can also be found
at <U>www.stemcellsinc.com</FONT><FONT style="font-size: 12pt"></U> </FONT><FONT style="font-size: 10pt">and</FONT><FONT style="font-size: 12pt"> </FONT><FONT style="font-size: 10pt"><U>www.clinicaltrials.gov</U>.
</FONT>

<P align="left" style="font-size: 10pt"><B>About Neuronal Ceroid Lipofuscinosis (Batten Disease)</B>


<P align="left" style="font-size: 10pt; text-indent: 4%">Neuronal ceroid lipofuscinosis (NCL)&nbsp;is a fatal lysosomal disorder that afflicts infants and
young children. The disorder, often referred to as Batten disease, is caused by genetic mutations,
and children who inherit the defective gene are unable to produce enough of an enzyme that
processes cellular waste substances that accumulate in a part of cells known as the lysosome.
Without the enzyme, the cellular waste builds up, and eventually the cells cannot function and die.
Children with NCL appear healthy when born, but as their brain cells die, they begin to suffer
seizures and progressively lose motor skills, sight and mental capacity. Eventually, they become
blind, bedridden and unable to communicate or function independently. There currently is no
effective treatment for the disease. The infantile and late infantile forms of NCL are caused by
different genetic mutations. As the names imply, the two forms begin to afflict patients at
different stages of infancy, but both have similar disease progression and outcomes.


<P align="left" style="font-size: 10pt; text-indent: 4%">StemCells has shown in preclinical studies that its HuCNS-SC cells produce the enzyme missing
in NCL and protect neurological function. The Company&#146;s clinical development strategy in NCL may
also provide important information on the applicability of HuCNS-SC cells for other lysosomal
storage disorders that affect the central nervous system, as well as for a broad range of other
neurological diseases.


<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%">StemCells has completed a Phase I clinical trial of its HuCNS-SC cells for the treatment of
NCL. Data from this trial demonstrated the clinical safety and tolerability of these cells. The
Company continues to follow patients who completed this trial, some of whom are two to three years
post-transplant. In addition to its clinical development in NCL, StemCells is currently conducting
a Phase I trial of HuCNS-SC cells as a potential treatment for Pelizaeus-Merzbacher Disease (PMD),
a fatal myelination disorder in children. 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 OHSU Doernbecher Children&#146;s Hospital</B>


<P align="left" style="font-size: 10pt; text-indent: 4%">OHSU Doernbecher Children&#146;s Hospital is a world-class facility that each year cares for tens
of thousands of children from Oregon, southwest Washington and around the nation, including
national and international referrals for specialty care. Children have access to a full range of
pediatric care, not just treatments for serious illness or injury, resulting in more than 147,000
outpatient visits, discharges, surgeries and pediatric transports annually. In addition, nationally
recognized physicians ensure that children receive exceptional care at OHSU Doernbecher, including
outstanding cancer treatment, specialized neurology care and highly sophisticated heart surgery in
the most patient- and family-centered environment. Pediatric experts from OHSU Doernbecher travel
throughout Oregon and southwest Washington to provide specialty care to some 3,000 children at more
than 150 outreach clinics in 13 locations.


<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 NCL and other serious neurodegenerative diseases; the prospects
associated with measuring clinical benefit, successfully completing the Phase Ib NCL trial, and
pursuing future clinical trials in NCL, including a pivotal trial in NCL or in another indication;
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 NCL, PMD, 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 NCL may not be predicative of results that would be obtained in regard to other
lysosomal storage disorders or other CNS conditions; 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
Form&nbsp;10-Q and </I><I>Form 8-K</I><I>.</I>


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