<SEC-DOCUMENT>0001299933-12-000760.txt : 20120402
<SEC-HEADER>0001299933-12-000760.hdr.sgml : 20120402
<ACCEPTANCE-DATETIME>20120402090900
ACCESSION NUMBER:		0001299933-12-000760
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20120402
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20120402
DATE AS OF CHANGE:		20120402

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:		12731334

	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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<TYPE>8-K
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<DESCRIPTION>LIVE FILING
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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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	April 2, 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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	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>
[&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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	Item 8.01 Other Events.
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On April 2, 2012, StemCells, Inc. (the "Company") issued a press release announcing summary trial results from the Company's clinical study of its HuCNS-SC cells (purified human neural stem cells) in patients with Pelizaeus-Merzbacher disease, a rare hypo-myelination disorder in children. A copy of this press release is attached hereto as Exhibit 99.1.  <br><br>The data from the study provide evidence of progressive and durable donor-cell derived myelination in all four patients who underwent transplantation with the Company&#x2019;s proprietary HuCNS-SC cells. 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.  <br><br>A summary of the trial results were presented on Saturday, March 31, at the 2012 European Leukodystrophy Association (ELA) Families/Scientists Meeting in Paris by the study's principal investigator, David H. Rowitch, M.D., Ph.D., UCSF professor of pediatrics and neurological surgery, chief of neonatology at UCSF Benioff Children&#x2019;s Hospital, member of the Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research at UCSF, and a Howard Hughes Medical Institute investigator. <br><br>The Company will host a live conference call and webcast today, April 2, at 11:00 AM Eastern Time (8:00 AM Pacific Time) to discuss the summary trial results. Interested parties are invited to listen to the call over the Internet via the Investors section of the Company&#x2019;s website at http://investor.stemcellsinc.com/phoenix.zhtml?c=86230&p=irol-irhome.  An archived version of the webcast will be available for replay on the Company&#x2019;s website beginning approximately two hours following the conclusion of the live call and continuing for a period of 30 days.
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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 April 2, 2012, announcing trial results from the Company's clinical study of HuCNS-SC cells in patients with Pelizaeus-Merzbacher disease.<br>
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	SIGNATURES
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	Pursuant to the requirements of the Securities Exchange Act of 1934, the
	registrant has duly caused this report to be signed on its behalf by the
	undersigned hereunto duly authorized.
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	StemCells, Inc.
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	April 2, 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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	99.1
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Press Release, dated April 2, 2012, announcing trial results from the Company's clinical study of HuCNS-SC cells in patients with Pelizaeus-Merzbacher disease.
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<P align="left" style="font-size: 10pt"><FONT style="font-size: 11pt"><img src="e35874-1289154516773879a0_1.jpg">
</FONT>

<P align="center" style="font-size: 11pt"><B>STEMCELLS, INC&#146;S MILESTONE CLINICAL TRIAL IN PELIZAEUS-MERZBACHER DISEASE SHOWS EVIDENCE OF<BR>
MYELINATION FOLLOWING HUMAN NEURAL STEM CELL TRANSPLANTATION</B>



<P align="center" style="font-size: 11pt"><I>Trial Provides Proof-of-Concept for Cell-Based Therapy in a Myelination Disorder<BR>
Company to Host Conference Call Today to Discuss Summary Results</I>



<P align="left" style="font-size: 11pt"><B>NEWARK, CA (April&nbsp;2, 2012) &#150; </B>StemCells, Inc. (Nasdaq: STEM) today announced preliminary evidence of
progressive and durable donor-cell derived myelination in all four patients who underwent
transplantation with the Company&#146;s proprietary HuCNS-SC&#174; cells (purified human neural stem cells)
in its clinical trial for Pelizaeus-Merzbacher disease (PMD), a rare hypo-myelination disorder in
children. 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 study was conducted by researchers at the University of California, San Francisco (UCSF).


<P align="left" style="font-size: 11pt">A summary of the trial results were presented Saturday, March&nbsp;31, at the 2012 European
Leukodystrophy Association (ELA)&nbsp;Families/Scientists Meeting in Paris. The findings are being
submitted for publication in a peer-reviewed scientific journal.


<P align="left" style="font-size: 11pt">&#147;The results from this Phase I study are meaningful and important,&#148; said </FONT><FONT style="font-size: 10.5pt">study investigator
Nalin Gupta, MD, PhD, UCSF associate professor of neurological surgery and pediatrics and chief of
pediatric neurological surgery at UCSF Benioff Children&#146;s Hospital</FONT><FONT style="font-size: 11pt">. &#147;The safety and clinical
outcomes a year after transplantation in this Phase I study, combined with durable radiological
signals of myelin formation, provide objective evidence of a biological effect of HuCNS-SC
transplantation that addresses the fundamental basis of the pathology in the brain of PMD patients.
We also wish to recognize the families&#146; contribution to this study. These advances would not be
possible without their willingness to participate in this clinical research.&#148;
</FONT>

<P align="left" style="font-size: 11pt">Patients with PMD have a defective gene, which leads to insufficient myelin in the brain. The
disease occurs only in males, and those with the most severe form of the disease, connatal PMD, are
significantly disabled from birth and usually die, within the first decade of life. The study was
the first to test transplantation of neural stem cells as a potential treatment for a myelination
disorder. Myelin is the substance that surrounds and insulates nerve cells&#146; communications fibers
(also known as axons). Without sufficient myelination, these fibers are unable to properly transmit
nerve impulses, leading to a progressive loss of neurological function, and death.


<P align="left" style="font-size: 11pt">The open-label Phase I trial, conducted between February&nbsp;2010 and February&nbsp;2012, enrolled four
patients with the connatal form of PMD, between the ages of 14&nbsp;months and 5&nbsp;years, and was designed
to assess safety and preliminary efficacy of the intervention. The study used magnetic resonance
(MR)&nbsp;imaging, commonly employed in other neurological diseases, to explore signs of myelination
related to the transplanted neural stem cells. The HuCNS-SC transplants were surgically delivered
to multiple sites within the frontal lobes of the brain. Patients also received immunosuppression
for nine months following transplantation and underwent intensive follow-up neurological
assessments and MR imaging for twelve months following transplantation. A separate four-year
observational study will continue to monitor and report the future progress for all four patients.


<P align="left" style="font-size: 11pt">At the one-year interval, MR imaging showed changes compatible with increased myelination in the
region of the transplantation. The MR signs of myelination persisted after the withdrawal of
immunosuppression at nine months and were also found to progress over time. The development of new
myelin signals is unprecedented in patients with connatal PMD and is consistent with HuCNS-SC
engraftment.


<P align="left" style="font-size: 11pt">&#147;The finding of myelin formation in this first exploratory study is indeed very encouraging,&#148; said
Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc. &#147;We
believe that the results of this trial provide proof-of-concept and a compelling rationale for the
Company to begin planning for a controlled Phase II study in PMD. These results may also have
implications for other leukodystrophies, as well as more common myelin disorders including
transverse myelitis, multiple sclerosis and periventricular white matter injury seen in Cerebral
Palsy. We are very pleased to be working with investigators at UCSF and deeply appreciate the
critical research expertise they have dedicated to the trial.&#148;


<P align="left" style="font-size: 11pt"><B>Conference Call</B>


<P align="left" style="font-size: 11pt">StemCells will host a live conference call and webcast today, April&nbsp;2, at 11:00 AM Eastern Time
(8:00 AM Pacific Time) to discuss the summary trial results. Interested parties are invited to
listen to the call over the Internet via the Investors section of the Company&#146;s website at
http://investor.stemcellsinc.com/phoenix.zhtml?c=86230&p=irol-irhome. An archived version of the
webcast will be available for replay on the Company&#146;s website beginning approximately two hours
following the conclusion of the live call and continuing for a period of 30&nbsp;days.


<P align="center" style="font-size: 10pt; display: none">1
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<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 cells (purified human neural stem cells), is currently in
development as a potential treatment for a broad range of central nervous system disorders. In
addition to the recently completed Phase I clinical trial in PMD, the Company is 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).
The Company is also continuing to pursue preclinical studies of HuCNS-SC cells in Alzheimer&#146;s
disease. Further information about StemCells is available at http://www.stemcellsinc.com.


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


<P align="left" style="font-size: 11pt">UCSF is a leading university dedicated to promoting health worldwide through advanced biomedical
research, graduate-level education in the life sciences and health professions, and excellence in
patient care.


<P align="left" style="font-size: 11pt"><B>About UCSF Benioff Children&#146;s Hospital</B>


<P align="left" style="font-size: 11pt">UCSF Benioff Children&#146;s Hospital creates an environment where children and their families find
compassionate care at the forefront of scientific discovery, with more than 150 experts in 50
medical specialties serving patients throughout Northern California and beyond. The hospital
admits about 5,000 children each year, including 2,000 babies born in the hospital. For more
information, visit&nbsp;www.ucsfbenioffchildrens.org.


<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 timing and
prospect associated with beginning to detect potential clinical benefit from the use of the
Company&#146;s HuCNS-SC cells; the prospect for continued clinical development of the Company&#146;s HuCNS-SC
cells in CNS disorders; the timing and nature of the final data from the Company&#146;s Phase I clinical
study in PMD; and the adequacy of our existing supply of HuCNS-SC cells to complete our ongoing and
planned clinical trials. 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 in any future
clinical study; risks whether the FDA or other applicable regulatory agencies will permit the
Company to continue clinical testing in spinal cord injury, PMD or in future clinical trials of
proposed therapies for other diseases or conditions such as age-related macular degeneration;
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, age-related macular degeneration, 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, including such operations of the Company for non-therapeutic applications, and to
conduct the research, preclinical development and clinical trials necessary for regulatory
approvals; uncertainties about the Company&#146;s ability to secure funding from any governmental
agency, such as the California Institute of Regenerative Medicine; 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 results in preclinical research in animals will be
indicative of future clinical results in humans or 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 regarding the validity and enforceability of the Company&#146;s
patents; 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, 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">David Pitts
<BR>
Argot Partners
<BR>
(212)&nbsp;600-1902



<P align="center" style="font-size: 10pt; display: none">2




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