<SEC-DOCUMENT>0001299933-12-001232.txt : 20120517
<SEC-HEADER>0001299933-12-001232.hdr.sgml : 20120517
<ACCEPTANCE-DATETIME>20120517160440
ACCESSION NUMBER:		0001299933-12-001232
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20120517
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20120517
DATE AS OF CHANGE:		20120517

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:		12852004

	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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	May 17, 2012
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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>
	(State or other jurisdiction
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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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___________<BR>
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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>
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<B>
	Item 8.01 Other Events.
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On May 17, 2012, StemCells, Inc. (the "Company") issued a press release announcing the presentation of interim data from the Phase I/II clinical study of its HuCNS-SC cells (purified human neural stem cells) in patients with spinal cord injury. The data will be presented by Armin Curt, M.D., principal investigator for the study, on May 17, 2012, at the Interdependence 2012 Global SCI Conference, which is being held in Vancouver, British Columbia.  A copy of this press release is attached hereto as Exhibit 99.1.  <br><br>The interim data is from the first cohort of patients in the study, all of whom suffered a complete spinal cord injury in which there is no neurological function below the level of the injury.  There were no abnormal clinical, electrophysiological or radiological responses to the cells, and all the patients were neurologically stable through the first four months following transplantation of the cells.  Changes in sensitivity to touch were observed in two of the patients.  <br><br>The data from multiple evaluations of the patients during this four month period have been reviewed by an independent Data Safety Monitoring Committee, which has recommended that the study advance to enrollment of patients with incomplete neurological injury.  Enrollment is now underway and is open to patients in Europe, the United States and Canada with incomplete spinal cord injury.
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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 May 17, 2012, announcing interim data from the Company's clinical study of HuCNS-SC cells in patients with spinal cord injury.<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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	May 17, 2012
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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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	Exhibit No.
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	99.1
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Press Release of StemCells, Inc., dated May 17, 2012
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<P align="left" style="font-size: 10pt"><FONT style="font-size: 11pt"><img src="e36256-1213813384461621a4_1.jpg">
</FONT>

<P align="center" style="font-size: 11pt"><B>STEMCELLS, INC. REPORTS POSITIVE INTERIM SAFETY DATA FROM SPINAL CORD INJURY TRIAL</B>



<P align="center" style="font-size: 11pt"><B><I>Trial Proceeding to Enroll Patients with Incomplete Injury</I></B>



<P align="left" style="font-size: 11pt"><B>NEWARK, CA (May&nbsp;17, 2012) </B>&#150; StemCells, Inc. (Nasdaq: STEM) today announced completion of the first
planned interim safety review of the Company&#146;s Phase I/II spinal cord injury clinical trial, which
indicated that the surgery, immunosuppression and the cell transplants have been well-tolerated.
The trial, which is designed to evaluate the safety and preliminary efficacy of the Company&#146;s
proprietary HuCNS-SC&#174; cells (purified human neural stem cells), represents the first time that
neural stem cells have been transplanted as a potential therapeutic agent for spinal cord injury.
A summary of the data will be presented by Armin Curt, M.D., principal investigator for the
clinical trial, at the <I>Interdependence 2012 Global SCI Conference, </I>which is being held in
Vancouver, British Columbia, from May&nbsp;15 to 17, 2012.


<P align="left" style="font-size: 11pt">The interim data is from the first cohort of patients, all of whom suffered a complete spinal cord
injury in which there is no neurological function below the level of the injury. All patients
enrolled were transplanted with a dose of 20&nbsp;million cells at the site of injury in the thoracic
spinal cord. There were no abnormal clinical, electrophysiological or radiological responses to
the cells, and all the patients were neurologically stable through the first four months following
transplantation of the cells. Changes in sensitivity to touch were observed in two of the
patients. The data from multiple evaluations of the patients during this four month period have
been reviewed by an independent Data Safety Monitoring Committee, which has recommended that the
study advance to enrollment of patients with incomplete neurological injury. Enrollment is now
underway and is open to patients in Europe, the United States and Canada with incomplete spinal
cord injury. The trial, which is being conducted at Balgrist University Hospital, Zurich,
Switzerland, is the only ongoing clinical trial evaluating neural stem cell transplantation in
spinal cord injury.


<P align="left" style="font-size: 11pt">&#147;We are very encouraged by the interim safety outcomes for the first cohort,&#148; said Dr.&nbsp;Curt, who is
Professor and Chairman of the Spinal Cord Injury Center at the University of Zurich, and Medical
Director of the Paraplegic Center at Balgrist University Hospital. &#147;The patients in the trial are
being closely monitored and undergo frequent clinical examinations, radiological assessments by MRI
and sophisticated electrophysiology testing of spinal cord function. The comprehensive battery of
tests provides important safety data and is very reassuring as we progress to the next stage of the
trial.&#148;


<P align="left" style="font-size: 11pt">The <I>Interdependence 2012Global SCI Conference </I>is intended to bring together international
healthcare and research facilities to showcase their work through presentations, workshops and
exhibits and to discuss how to advance research, implement new best practices and shape the next
generation of spinal cord injury research. <I>Interdependence 2012 </I>is jointly organized by the Rick
Hansen Institute, a Canadian not-for-profit organization committed to accelerating the translation
of discoveries and best practices into improved treatments for people with spinal cord injuries,
and the Rick Hansen Foundation.


<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. 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 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. The injuries are classified according to the American Spinal Injury
Association Impairment Scale (AIS). In addition to assessing safety, the trial will assess
preliminary efficacy based on defined clinical endpoints, such as changes in sensation, motor and
bowel/bladder 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 a separate
four-year observational study will be initiated at the conclusion of this trial.


<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. 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; The
Company recently reported results from a Phase I clinical trial in Pelizaeus-Merzbacher disease
(PMD), a fatal myelination disorder in children. The trial results showed 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 received authorization from the FDA to initiate a Phase I/II clinical trial in
dry age-related macular degeneration (AMD). In addition, the Company is pursuing preclinical
studies of its HuCNS-SC cells 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 the prospect of retaining
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 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 PMD, spinal cord injury 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
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 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
Form&nbsp;10-Q 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>
