<SEC-DOCUMENT>0001299933-13-001425.txt : 20130805
<SEC-HEADER>0001299933-13-001425.hdr.sgml : 20130805
<ACCEPTANCE-DATETIME>20130802182311
ACCESSION NUMBER:		0001299933-13-001425
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20130802
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20130805
DATE AS OF CHANGE:		20130802

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:		131008308

	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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	August 2, 2013
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	StemCells, Inc.
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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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	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
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	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
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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>
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	Item 8.01 Other Events.
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On August 2, 2013, StemCells, Inc. (the "Company") issued a press release announcing positive two-year clinical results from the study of its proprietary HuCNS-SC cells in patients with Pelizaeus-Merzbacher disease.  Notably, the neurological and MRI changes seen in the patients since transplantation of the cells suggest a departure from the natural history of the disease and may represent signals of a clinical effect.  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 August 2, 2013, announcing two-year data from the Company's clinical study of HuCNS-SC cells in patients with Pelizaeus-Merzbacher disease.<br>
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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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	August 2, 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 August 2, 2013
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<P align="left" style="font-size: 10pt"><FONT style="font-size: 11pt"><img src="e38631-13214172558635dcbe_1.jpg">
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<P align="center" style="font-size: 11pt"><B>STEMCELLS, INC. PRESENTS TWO-YEAR PELIZAEUS-MERZBACHER DISEASE (PMD)&nbsp;DATA SUGGESTING<BR>
DEPARTURE FROM NATURAL HISTORY OF THE DISEASE</B>



<P align="left" style="font-size: 11pt"><B>NEWARK, Calif., (August&nbsp;2, 2013) &#150; </B>StemCells, Inc. (Nasdaq: STEM) today presented data which show
that two years after transplantation of the Company&#146;s proprietary HuCNS-SC&#174; cells (purified human
neural stem cells) into patients with Pelizaeus-Merzbacher disease (PMD), the evidence of
myelination, by magnetic resonance imaging (MRI), is more pronounced compared to one year
post-transplantation, the gains in neurological function reported after one year were maintained,
and there were no safety concerns. Patients with PMD have a defective gene which leads to
insufficient myelin in the brain, resulting in progressive loss of neurological function and death.
The neurological and MRI changes suggest a departure from the natural history of the disease and
may represent signals of a clinical effect. The data was presented today by Stephen Huhn, MD,
FACS, FAAP, Vice President, CNS Clinical Research at StemCells, Inc., at the <I>2013
Pelizaeus-Merzbacher Disease Symposium and Health Fair </I>being held at Nemours/Alfred I. duPont
Children&#146;s Hospital in Wilmington, Del.


<P align="left" style="font-size: 11pt">&#147;We are encouraged that the MRI data continue to indicate new and durable myelination related to
the transplanted cells and that the data is even stronger after two years compared to one year,&#148;
said Dr.&nbsp;Huhn. &#147;Even in the context of a small open-label study, these MRI results, measured at
time points long after transplantation, make an even more convincing case that the HuCNS-SC cells
are biologically active and that their effect is measureable, sustainable and progressive. Our
challenge now is to reach agreement with the FDA on how best to correlate changes in MRI with
meaningful clinical benefit, as this will be a critical step in determining a viable registration
pathway for PMD.&#148;


<P align="left" style="font-size: 11pt">In the Company&#146;s Phase I trial, which was conducted at the University of California, San Francisco,
four patients with connatal PMD, the most severe form of the disease, were enrolled and
transplanted with HuCNS-SC cells. The patients were followed for twelve months after
transplantation, during which time they underwent intensive neurological assessments and magnetic
resonance imaging at regular intervals. The Phase I trial results indicate a favorable safety
profile for the HuCNS-SC cells and the transplantation procedure. Analysis of the MRI data showed
changes consistent with increased myelination in the region of the transplantation, which
progressed over time and persisted after the withdrawal of immunosuppression at nine months. The
results support the conclusion of durable cell engraftment and donor cell-derived myelin in the
transplanted patients&#146; brains. In addition, clinical assessment revealed small but measureable
gains in motor and/or cognitive function in three of the four patients; the fourth patient remained
clinically stable. The Phase I trial results were published in October&nbsp;2012 in <I>Science
Translational Medicine, </I>the peer review journal of the American Association for the Advancement of
Science. Upon completion of the Phase I trial, all four patients were enrolled into a long-term
follow up study, which is designed to follow the patients for four more years.


<P align="left" style="font-size: 11pt">The <I>Pelizaeus-Merzbacher Disease Symposium and Health Fair </I>is intended to help educate families and
healthcare professionals about PMD and related disorders. Sponsors include The PMD Foundation, a
non-profit organization formed to raise awareness of the disease, create support for people with
PMD, reduce misdiagnosis of PMD, and fund scientific research, and Nemours Biomedical Research, a
branch of the Nemours Foundation, which is dedicated to improving the health and health care of all
children.


<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 also 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 trial sites in the
US. In addition, the Company is pursuing preclinical studies in Alzheimer&#146;s disease, with funding
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 U.S. securities laws, and is subject to the
safe harbors created therein. These statements include, but are not limited to, statements
regarding the future business operations of StemCells, Inc. (the &#147;Company&#148;); the prospect for
continued clinical development of the Company&#146;s HuCNS-SC cells in CNS disorders; and the timing and
nature of data from the Company&#146;s clinical studies in PMD. 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 uncertainties with respect to the fact that additional trials will be
required to confirm the safety and demonstrate the efficacy of the Company&#146;s HuCNS-SC cells for the
treatment of spinal cord injury, PMD or any other condition; uncertainties about whether
myelination formed by donor cells, if any, will have any biologic effect; uncertainties about
whether preliminary data in any Phase&nbsp;I clinical study will prove to be reproducible or
biologically meaningful; risks whether the FDA or other applicable regulatory agencies will permit
the Company to continue clinical testing of its HuCNS-Sc cells, ; uncertainties about the design of
future clinical trials and whether the Company will receive the necessary support of a clinical
trial site and its institutional review board to pursue future clinical trials in spinal cord
injury, PMD, AMD, or in proposed therapies for other diseases or 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 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;
uncertainties regarding whether data generated in clinical studies of one disease or condition will
be predictive of outcomes in other diseases or conditions; uncertainties regarding the Company&#146;s
manufacturing capabilities given its increasing preclinical and clinical commitments; uncertainties
as to whether the Company will become profitable; and other factors that are described under the
heading &#147;Risk Factors&#148; disclosed in Part&nbsp;I, Item&nbsp;1A 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 </I><I>Form 10-Q</I><I> and </I><I>Form 8-K</I><I>.</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
<BR>
(619)&nbsp;308-6541



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`
end
</TEXT>
</DOCUMENT>
</SEC-DOCUMENT>
