<SEC-DOCUMENT>0001299933-13-001651.txt : 20130912
<SEC-HEADER>0001299933-13-001651.hdr.sgml : 20130912
<ACCEPTANCE-DATETIME>20130912164650
ACCESSION NUMBER:		0001299933-13-001651
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20130912
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20130912
DATE AS OF CHANGE:		20130912

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:		131094592

	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
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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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	September 12, 2013
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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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	7707 Gateway Blvd, Suite 140, Newark, California
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	94560
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	510.456.4000
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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
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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On September 12, 2013, StemCells, Inc. (the "Company") issued a press release announcing the dosing of the first high-dose patient in the Company's Phase I/II trial in age-related macular degeneration ("AMD").  The patient was the fifth transplanted in the study and the first to receive one million HuCNS-SC cells.  A copy 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, dated September 12, 2013, announcing first high-dose transplantation in the Company's AMD study.<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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	September 12, 2013
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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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	99.1
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Press release dated September 12, 2013
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<P align="left" style="font-size: 10pt"><FONT style="font-size: 11pt"><img src="e38808-1325516406243ddb3c_1.jpg">
</FONT>

<P align="center" style="font-size: 11pt"><B>STEMCELLS, INC. ANNOUNCES FIRST HIGH-DOSE PATIENT TRANSPLANTED<BR>
IN PHASE I/II CLINICAL TRIAL IN DRY AGE-RELATED MACULAR DEGENERATION</B>



<P align="center" style="font-size: 11pt"><I>FDA Authorizes Expansion to Five Trial Sites in the United States</I>



<P align="left" style="font-size: 11pt"><B>NEWARK, Calif., (September&nbsp;12, 2013) </B>&#150; StemCells, Inc. (Nasdaq: STEM) today announced dosing of
the first high-dose patient in the Company&#146;s Phase I/II clinical trial in dry age-related macular
degeneration (AMD). The patient, the fifth overall in the 16-patient trial, was transplanted
yesterday with one million HuCNS-SC&#174; cells (purified human neural stem cells). The first four
patients each received a dose of 200,000 cells. An independent Data Safety Monitoring Committee
conducted a review of the trial data to date, and found no safety issues to preclude the trial from
proceeding to the high dose.


<P align="left" style="font-size: 11pt">&#147;Advancing to the high dose, which is a five-fold increase from the low dose, is an important
milestone in this trial,&#148; said Stephen Huhn, MD, FACS, FAAP, Vice President, CNS Clinical Research
at StemCells. &#147;Testing a cell dose of this magnitude in all the remaining patients planned for the
trial will enhance our ability to assess the effect of the cells on visual acuity.


<P align="left" style="font-size: 11pt">&#147;Also, we are pleased to announce that we have received permission from the FDA to open three more
U.S. trial sites in addition to the Retina Foundation of the Southwest and the Byers Eye Institute
at Stanford, the two currently active centers. Expanding the number of sites will provide easier
access to the trial for patients and help us achieve our goal of completing enrollment within the
next nine months.&#148;


<P align="left" style="font-size: 11pt">AMD afflicts approximately 30&nbsp;million people worldwide and is the leading cause of vision loss in
people over 55&nbsp;years of age. Approximately 90&nbsp;percent of AMD patients have the dry form of the
disease, for which there are no approved treatments.


<P align="left" style="font-size: 11pt"><B>About the Clinical Trial</B>


<P align="left" style="font-size: 11pt">The Phase I/II trial is designed to evaluate the safety and preliminary efficacy of HuCNS-SC cells
as a treatment for dry AMD. The trial is an open-label, dose-escalation study, and is expected to
enroll a total of 16 patients. The HuCNS-SC cells will be administered by a single injection into
the space beneath the retina in the most affected eye. Using both conventional and advanced
state-of-the-art methods of ophthalmological assessment, patients will be evaluated at
predetermined intervals over a one-year period to assess safety and signs of visual benefit.
Patients will then be followed for an additional four years in a separate observational study.


<P align="left" style="font-size: 11pt">The trial is currently enrolling at the Byers Eye Institute at Stanford in Palo Alto, California,
and at the Retina Foundation of the Southwest in Dallas, Texas. Patients interested in
participating in the clinical trial should contact the Byers Eye Institute at Stanford at (650)
498-4486 or the Retina Foundation of the Southwest at (214)&nbsp;363-3911.


<P align="left" style="font-size: 11pt">A summary of the Company&#146;s preclinical data underlying the trial was featured in February&nbsp;2012 in
the peer-reviewed <I>European Journal of Neuroscience</I>
(<U>http://onlinelibrary.wiley.com/doi/10.1111/j.1460-9568.2011.07970.x/abstract</U>). The data
demonstrated that HuCNS-SC cells protect host photoreceptors and preserve vision in the Royal
College of Surgeons (RCS)&nbsp;rat, a well-established animal model of retinal disease that has been
used extensively to evaluate potential cellular therapies. Transplantation of HuCNS-SC cells into
RCS rats significantly protected photoreceptors from degeneration. Moreover, the number of cone
photoreceptors, which are responsible for central vision, remained constant over an extended
period, consistent with the sustained visual acuity and light sensitivity observed in the study.&nbsp;
In humans, degeneration of the cone photoreceptors accounts for the unique pattern of vision loss
in dry AMD.


<P align="left" style="font-size: 11pt"><B>About HuCNS-SC Cells</B>


<P align="left" style="font-size: 11pt">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 clinical studies.


<P align="left" style="font-size: 11pt"><B>About StemCells, Inc.</B>


<P align="left" style="font-size: 11pt">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. The Company&#146;s lead
therapeutic product candidate, HuCNS-SC&#174; cells (purified human neural stem cells), is currently in
development as a potential treatment for a broad range of central nervous system disorders. &nbsp;In a
Phase&nbsp;I clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in
children, the Company has shown preliminary evidence of progressive and durable donor-derived
myelination in all four patients transplanted with HuCNS-SC cells. The Company is conducting a
Phase I/II clinical trial in chronic spinal cord injury in Switzerland and Canada and has reported
positive interim data for the first three patients. The Company is also conducting a Phase I/II
clinical trial in dry age-related macular degeneration (AMD)&nbsp;at two sites in the United States. In
addition, the Company is pursuing preclinical studies in Alzheimer&#146;s disease, with support from the
California Institute for Regenerative Medicine (CIRM). &nbsp; StemCells also markets stem cell research
products, including media and reagents, under the SC Proven&#174; brand. Further information about
StemCells is available at <U>http://www.stemcellsinc.com</U>.


<P align="left" style="font-size: 11pt"><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 the
Company&#146;s HuCNS-SC cells to preserve vision; the prospect and timing of patient enrollment in the
Company&#146;s clinical trial in dry AMD; and the future business operations of the Company. 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 or review boards will permit the Company to continue clinical testing in AMD;
uncertainties regarding the timing and duration of any clinical trials; uncertainties regarding the
Company&#146;s ability to recruit the patients required to conduct its clinical trials 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 cells 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; ; 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, 2012, and in its
subsequent reports on Forms 10-Q and 8-K.</I>


<P align="left" style="font-size: 11pt">CONTACT:


<P align="left" style="font-size: 11pt">Rodney Young
<BR>
StemCells, Inc.
<BR>
Chief Financial Officer
<BR>
(510)&nbsp;456-4128


<P align="left" style="font-size: 11pt">Ian Stone
<BR>
Russo Partners
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`
end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
