<SEC-DOCUMENT>0001299933-15-000582.txt : 20150417
<SEC-HEADER>0001299933-15-000582.hdr.sgml : 20150417
<ACCEPTANCE-DATETIME>20150416201020
ACCESSION NUMBER:		0001299933-15-000582
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20150416
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20150417
DATE AS OF CHANGE:		20150416

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:		15776359

	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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	April 16, 2015
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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>
[&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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Earlier today, StemCells, Inc. (the "Company") issued a press release announcing that it has completed transplanting the six patients comprising the first cohort of its Phase II Pathway&#174; Study in cervical spinal cord injury. A copy of the 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)<br>Exhibit 99.1 Press Release, dated April 16, 2015, announcing that the Company has completed enrollment in the first cohort of its Phase II clinical trial in spinal cord injury.<br><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
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	StemCells, Inc.
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	April 16, 2015
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	By:
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	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 16, 2015
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<P align="center" style="font-size: 10pt"><FONT style="font-size: 12pt"><BR>
<B>StemCells, Inc. Completes Enrollment of First Cohort in Phase II Pathway Study for Cervical Spinal<BR>
Cord Injury</B></FONT>



<P align="center" style="font-size: 12pt"><I>Proof-of-concept study designed to measure improvement in motor function</I>



<P align="center" style="font-size: 12pt"><I><img src="e41252-151061734525476932_2.jpg"></I>



<P align="left" style="font-size: 12pt"><FONT style="font-size: 10pt"><B>NEWARK, CA, April&nbsp;16, 2015 </B>(GLOBE NEWSWIRE) &#151; StemCells, Inc. (NASDAQ: STEM), a leading stem
cell company developing novel cell-based therapeutics for treating diseases of the central nervous
system with high unmet medical need, announced today that it has completed transplanting the six
patients comprising the first cohort of its Phase II Pathway<sup>&#174;</sup> Study. The first cohort is
an open-label dose escalation arm to determine the cell dose to be used for the second cohort of
the study. The second cohort of the study is a single-blind arm in 40 patients that will assess
efficacy of the Company&#146;s proprietary HuCNS-SC<sup>&#174;</sup> (purified human neural stem cells)
platform technology for the treatment of cervical spinal cord injury (SCI).
</FONT>

<P align="left" style="font-size: 10pt">&#147;We are breaking new ground with this study,&#148; said Stephen Huhn, M.D., FACS, FAAP, vice president,
CNS clinical research and CMO at StemCells, Inc. &#147;This is the first controlled study to use neural
stem cells with the intent to demonstrate improvement in motor function following spinal cord
injury. In this first cohort, we have achieved the highest number of neural stem cells administered
into the injured human spinal cord in medical history. We expect to release six month interim data
on the first cohort later this year.


<P align="left" style="font-size: 10pt">&#147;Interest in this study from both physicians and patients has been very encouraging, resulting in
the rapid enrollment of this cohort. The Company is using web-based recruitment and, in the first
six months, we have seen over 1,500 inquiries and 500 completed questionnaires and over 100
subjects have been reviewed for possible eligibility. Our experience with the first cohort reflects
great clinical momentum, as well as the excitement within the spinal cord injury community for
potential novel treatments. Detecting evidence of motor improvement in this Phase II study would
provide proof-of-concept for this approach in spinal cord injury and would ultimately lead to a
therapy that dramatically enhances the quality of life for those afflicted with spinal cord
injuries.&#148;


<P align="left" style="font-size: 10pt"><FONT style="font-size: 11pt"><B>About the Pathway Spinal Cord Injury Clinical Trial</B>
</FONT>

<P align="left" style="font-size: 11pt"><FONT style="font-size: 10pt">The Pathway Phase II study, titled &#147;Study of Human Central Nervous System (CNS)&nbsp;Stem Cell
Transplantation in Cervical Spinal Cord Injury,&#148; will evaluate the safety and efficacy of
transplanting the Company&#146;s proprietary human neural stem cells (HuCNS-SC cells), into patients
with traumatic injury in the cervical region of the spinal cord. Conducted as a randomized,
controlled, single-blind study, the trial will measure efficacy by assessing motor function
according to the International Standards for Neurological Classification of Spinal Cord Injury
(ISNCSCI). The primary efficacy outcome will focus on change in upper extremity strength as
measured in the hands, arms and shoulders. The trial will enroll approximately 52 subjects and
follow the patients for 12&nbsp;months post-transplant.
</FONT>

<P align="left" style="font-size: 10pt">Information about the Company&#146;s spinal cord injury program can be found on the StemCells, Inc.
website at:


<P align="left" style="font-size: 10pt"><U>http://www.stemcellsinc.com/Clinical-Programs/SCI</U>


<P align="left" style="font-size: 10pt">Information on the Company&#146;s pre-clinical spinal cord injury research, along with an animation on
the science of HuCNS-SC cells for the treatment of spinal cord injuries, can be found at:


<P align="left" style="font-size: 10pt"><U>http://www.stemcellsinc.com/Science/Pre-Clinical-Studies/About-SCI</U>


<P align="left" style="font-size: 10pt">Information for patients interested in participating in the study is available at the Pathway
website at:


<P align="left" style="font-size: 10pt"><U>http://www.sciresearchstudy.com</U>


<P align="left" style="font-size: 10pt">Additional information about the clinical trial is available at:


<P align="left" style="font-size: 10pt"><U>
http://clinicaltrials.gov/ct2/show/NCT02163876?term=stem&#043;cells&#043;cervical&#043;spinal&#043;cord&#043;injury&rank=1</u
>


<P align="left" style="font-size: 10pt"><FONT style="font-size: 11pt"><B>About HuCNS-SC Cells</B>
</FONT>

<P align="left" style="font-size: 11pt"><FONT style="font-size: 10pt">StemCells, Inc. has demonstrated human safety data from completed and ongoing clinical studies
in which its proprietary HuCNS-SC cells have been transplanted directly into all three components
of the central nervous system: the brain, the spinal cord and the eye. StemCells, Inc. clinicians
and scientists believe that HuCNS-SC cells may have broad therapeutic application for many diseases
and disorders of the CNS. Because the transplanted HuCNS-SC cells have been shown to engraft and
survive long-term, there is the possibility of a durable clinical effect following a single
transplantation. The HuCNS-SC platform technology is a highly purified composition of human neural
stem cells (tissue-derived or &#147;adult&#148; stem cells). Manufactured under cGMP standards, the Company&#146;s
HuCNS-SC cells are purified, expanded in culture, cryopreserved, and then stored as banks of cells,
ready to be made into individual patient doses when needed.
</FONT>

<P align="left" style="font-size: 10pt"><FONT style="font-size: 11pt"><B>About StemCells, Inc.</B>
</FONT>

<P align="left" style="font-size: 11pt"><FONT style="font-size: 10pt">StemCells, Inc. is currently engaged in clinical development of its platform technology,
HuCNS-SC<sup>&#174;</sup> (purified human neural stem cells) as a potential treatment for disorders of
the central nervous system (CNS). Interim data from the Company&#146;s Phase I/II clinical trial in
thoracic spinal cord injury (SCI)&nbsp;shows measurable gains involving multiple sensory modalities and
segments, including the conversion of 2 of 7 patients enrolled in the study with complete injuries
(AIS A) converting to incomplete injuries (AIS B), post-transplant. Enrollment has recently
commenced in the Company&#146;s Phase II clinical trial in cervical SCI. StemCells, Inc. has also
completed enrollment and treatment in its Phase I/II clinical trial in geographic atrophy of
age-related macular degeneration (GA-AMD), the most severe form of dry AMD, which is the leading
cause of blindness in the elderly. Based upon interim results for subjects with twelve months data,
the Company reported a 70&nbsp;percent reduction in the rate of disease progression as compared to the
control (untreated)&nbsp;eye and a 65&nbsp;percent reduction in the rate of disease progression as compared
to the expected natural history of the disease. In a Phase&nbsp;I clinical trial in Pelizaeus-Merzbacher
disease (PMD), a fatal myelination disorder in children, the Company showed preliminary evidence of
progressive and durable donor-derived myelination in all four patients transplanted with HuCNS-SC
cells.&nbsp;Further information about StemCells, Inc. is available at
<U>http://www.stemcellsinc.com</U>.
</FONT>

<P align="left" style="font-size: 10pt"><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
prospects associated with detecting 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; and the speed of patient enrollment in the Company&#146;s studies. 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, AMD, PMD, or any other condition;
uncertainties about whether preliminary data in any Phase 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 or
conduct future clinical trials; 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 results in preclinical
research in animals will be indicative of future clinical results in humans; 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, 2014 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: 10pt">CONTACT:


<P align="left" style="font-size: 10pt">Greg Schiffman
<BR>
StemCells, Inc.
<BR>
Chief Financial Officer
<BR>
(510)&nbsp;456-4128


<P align="left" style="font-size: 10pt">Lena Evans
<BR>
Russo Partners
<BR>
(212)&nbsp;845-4262


<P align="center" style="font-size: 10pt">#####




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




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