<SEC-DOCUMENT>0001299933-13-000297.txt : 20130213
<SEC-HEADER>0001299933-13-000297.hdr.sgml : 20130213
<ACCEPTANCE-DATETIME>20130213160346
ACCESSION NUMBER:		0001299933-13-000297
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20130212
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20130213
DATE AS OF CHANGE:		20130213

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:		13603067

	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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	February 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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	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 February 12, 2013, StemCells, Inc. (the "Company") issued a press release with an update on the first patient cohort in the Company's Phase I/II clinical study in chronic spinal cord injury. The patients in the first cohort, consisting of three AIS A patients, have completed the study and twelve-month data from this cohort continued to demonstrate a favorable safety profile for the product and procedure and showed that the gains in sensory function observed in two of the three patients at the six-month assessment have persisted.  The third patient remains stable.  One of the patients in the cohort has converted from a complete injury assessment (AIS A) to an incomplete injury assessment (AIS B). <br><br>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 February 12, 2013, announcing twelve-month data on the first patient cohort in the Company's clinical study of HuCNS-SC cells in spinal cord injury.<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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	February 13, 2013
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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 February 12, 2013
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<P align="left" style="font-size: 10pt"><FONT style="font-size: 11pt"><img src="e37753-13441358304863f391_1.jpg">
</FONT>

<P align="center" style="font-size: 11pt"><B>STEMCELLS, INC. ANNOUNCES FIRST PATIENT COHORT COMPLETES SPINAL CORD INJURY TRIAL -<BR>
GAINS IN SENSORY FUNCTION PERSIST 12 MONTHS AFTER STEM CELL TRANSPLANT</B>



<P align="center" style="font-size: 11pt"><B><I>Improvement from Complete to Incomplete Injury Observed in One Patient</I></B>



<P align="left" style="font-size: 11pt"><B>NEWARK, CA (February&nbsp;12, 2013) </B>&#150; StemCells, Inc. (Nasdaq: STEM) today announced that the
twelve-month data from the first patient cohort in the Company&#146;s Phase I/II clinical trial of its
proprietary HuCNS-SC&#174; product candidate (purified human neural stem cells) for chronic spinal cord
injury continued to demonstrate a favorable safety profile, and showed that the considerable gains
in sensory function observed in two of the three patients at the six-month assessment have
persisted. The third patient remains stable. A summary of the data was presented today by Martin
McGlynn, President and CEO, at the 15<sup>th</sup> Annual <I>BIO CEO & Investor Conference</I>. By
completing the twelve-month assessment, the first patient cohort has now completed the trial, and
has entered into a separate follow-up study for long-term observation.


<P align="left" style="font-size: 11pt">&#147;The multi-segment gains observed in sensory function in two patients at six months have endured at
the 12-month assessment. In addition, between the six- and 12-month evaluations, one patient
converted from a complete to an incomplete injury,&#148; said Armin Curt, M.D., Professor and Chairman
of the Spinal Cord Injury Center at Balgrist University Hospital, University of Zurich and
principal investigator of the clinical trial. &#147;Importantly, the persistence of these sensory gains
at the 12-month evaluation was seen across more than one clinical measure. While much more
clinical research needs to be done to demonstrate efficacy, the types of changes we are observing
are unexpected and very encouraging given that these are patients in the chronic stage of complete
spinal injury.&#148;


<P align="left" style="font-size: 11pt">Mr.&nbsp;McGlynn added, &#147;While we need to be cautious when interpreting data from a small, uncontrolled
trial, to our knowledge, this is the first time a patient with a complete spinal cord injury has
been converted to a patient with an incomplete injury following transplantation of neural stem
cells. We are encouraged that the cells appear to convey clinical benefit in such severely
injured patients. We are therefore hopeful that we will see similar or greater benefit in AIS B
and C patients, who already have partial sensation and motor function below the level of injury
which could be further augmented by cell transplantation.&#148;


<P align="left" style="font-size: 11pt">Patients in the study&#146;s first cohort all suffered a complete injury to the thoracic (chest-level)
spinal cord. In a complete injury, there is no neurological function below the level of injury,
and sensory function of all three patients was stable before transplantation of the HuCNS-SC cells.
All three patients were transplanted four to nine months after injury with a dose of 20&nbsp;million
cells at the site of injury. The surgery, immunosuppression and the cell transplants have been
well tolerated by all the patients. There were no abnormal clinical, electrophysiological or
radiological responses to the cells, and all the patients have remained neurologically stable
through the first 12&nbsp;months following transplantation. Positive changes in sensitivity to touch,
heat and electrical stimuli were observed in well-defined and consistent thoracic regions in two of
the patients, while no changes were observed in the third patient. Importantly, quantitative tests
of specific sensory function, as well as electrophysiological measures of impulse transmission
across the site of injury, show an association with the clinical examination, providing further
objective confirmation of the sensory gains.


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


<P align="left" style="font-size: 11pt">The Phase I/II clinical trial of StemCells, Inc.&#146;s HuCNS-SC&#174; purified human adult neural stem cells
is designed to assess both safety and preliminary efficacy. Twelve patients with thoracic
(chest-level) neurological injuries at the T2-T11 level are planned for enrollment, and their
injuries must have occurred within three to twelve months prior to transplantation of the cells.
In addition to assessing safety, the trial will assess preliminary efficacy based on defined
clinical endpoints, such as changes in sensation, motor function and bowel/bladder function. The
Company has dosed the first three patients, all of whom have injuries classified as AIS A, in which
there is no neurological function below the injury level. The injuries are classified according to
the American Spinal Injury Association Impairment Scale (AIS). The second and third cohorts will
be patients classified as AIS B and AIS C, those with less severe injury, in which there is some
preservation of sensory or motor function.


<P align="left" style="font-size: 11pt">All patients will receive HuCNS-SC cells through direct transplantation into the spinal cord and
will be temporarily immunosuppressed. Patients will be evaluated regularly in the post-transplant
period in order to monitor and assess the safety of the HuCNS-SC cells, the surgery and the
immunosuppression, as well as to measure any recovery of neurological function below the injury
site. The Company intends to follow the effects of this therapy long-term, and each of the
patients will be invited to enroll into a separate four year observational study after completing
the Phase I/II study.


<P align="left" style="font-size: 11pt">The trial is being conducted at Balgrist University Hospital, University of Zurich, a world leading
medical center for spinal cord injury and rehabilitation, and is open for enrollment to patients in
Europe, Canada and the United States. Enrollment for the second cohort is currently underway, and
the first AIS B patient was enrolled and dosed late last year. If you believe you may qualify and
are interested in participating in the study, please contact the study nurse either by phone at &#043;41
44 386 39 01 or by email at <U>stemcells.pz@balgrist.ch</U>.


<P align="left" style="font-size: 11pt">Additional information about the Company&#146;s spinal cord injury program can be found on the
StemCells, Inc. website at
<U>http://www.stemcellsinc.com/Therapeutic-Programs/Clinical-Trials.htm</U> and at
<U>http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm</U>, including video
interviews with Company executives and independent collaborators.


<P align="left" style="font-size: 11pt"><B>About Balgrist University Hospital</B></FONT><FONT style="font-size: 10pt">
</FONT>

<P align="left" style="font-size: 10pt"><FONT style="font-size: 11pt">Balgrist University Hospital, University of Zurich is recognized worldwide as a highly
specialized center of excellence providing examination, treatment and rehabilitation opportunities
to patients with serious musculoskeletal conditions. The clinic owes its leading international
reputation to its unique combination of specialized medical services. The hospital&#146;s
carefully-balanced, interdisciplinary network brings together under one roof medical specialties
including orthopedics, paraplegiology, radiology, anesthesiology, rheumatology, and physical
medicine. More information about Balgrist University Hospital is available at
<U>www.balgrist.ch.</U>
</FONT>

<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 has reported positive
interim data for the first patient cohort. The Company has also initiated a Phase I/II clinical
trial in dry age-related macular degeneration (AMD), and is pursuing preclinical studies in
Alzheimer&#146;s disease.&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 whether the improvements in
sensory function seen in the Company&#146;s Phase I/II clinical study of spinal cord injury will persist
and whether they will prove to be clinically meaningful; continued authorization to conduct a
clinical trial in Switzerland in chronic spinal cord injury; the prospect for screening and then
enrolling patients into the AIS B and AIS C cohorts; the prospect for evaluating trial patients for
changes in their sensation, motor function and bowel/bladder function; the potential of the
Company&#146;s HuCNS-SC cells to treat spinal cord injury and other central nervous system disorders;
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 spinal cord injury or in future clinical trials of proposed
therapies for other diseases or conditions; 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
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; 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, 2011, 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



<P align="center" style="font-size: 10pt; display: none">




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