<SEC-DOCUMENT>0001299933-14-000590.txt : 20140417
<SEC-HEADER>0001299933-14-000590.hdr.sgml : 20140417
<ACCEPTANCE-DATETIME>20140417161517
ACCESSION NUMBER:		0001299933-14-000590
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20140415
ITEM INFORMATION:		Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20140417
DATE AS OF CHANGE:		20140417

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:		14770272

	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
<SEQUENCE>1
<FILENAME>htm_49651.htm
<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 15, 2014
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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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	(Commission
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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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___________<BR>
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	Registrant&#146;s telephone number, including area code:
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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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<P><FONT SIZE="2">
[&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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
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Dr. Stewart Craig has resigned from his position as the Company's EVP of Manufacturing Operations and Regulatory Affairs for personal reasons.  His employment termination date will be Friday, May 2, 2014.
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	Item 8.01 Other Events.
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On April 17, 2014, StemCells, Inc. (the "Company") issued a press release announcing the final patient dosing and completion of enrollment in the Company's Phase I/II clinical study in chronic spinal cord injury.  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 April 17, 2014, announcing completion of enrollment in the Company's Phase I/II clinical study in chronic spinal cord injury.
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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 17, 2014
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	By:
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	/s/ Ken Stratton, Attorney-in-Fact
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	Name: Ken Stratton, Attorney-in-Fact
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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 dated April 17, 2014
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<P align="left" style="font-size: 10pt"><FONT style="font-size: 11pt"><img src="e39720-14106163253257919e_1.jpg">
</FONT>

<P align="center" style="font-size: 11pt"><FONT style="font-size: 12pt"><B>StemCells, Inc. Completes Enrollment in Spinal Cord Injury Trial</B></FONT>



<P align="center" style="font-size: 12pt"><FONT style="font-size: 11pt"><I>Interim Data to Be Presented at Upcoming American Spinal Injury Association Conference</I></FONT>



<P align="left" style="font-size: 11pt"><FONT style="font-size: 10pt"><B>NEWARK, CA, April&nbsp;17, 2014 </B>(GLOBE NEWSWIRE) &#151; StemCells, Inc. (Nasdaq:STEM) announced today
that it has completed enrollment in the Company&#146;s Phase I/II clinical trial in spinal cord injury.
The multi-national, open-label, Phase I/II trial is evaluating both safety and preliminary efficacy
of StemCells, Inc.&#146;s proprietary HuCNS-SC&#174;<sup> </sup>human neural stem cells as a treatment for
chronic spinal cord injury. The trial enrolled twelve subjects with chest-level injury to the
spinal cord. The trial enrolled seven patients with complete paralysis, no motor or sensory
function below the point of injury, classified as complete (AIS A), according to the American
Spinal Injury Association Impairment Scale, and five patients with no motor function and limited
sensory function below the point of injury classified as incomplete (AIS B). Zurich study site
principal investigator, Dr.&nbsp;Armin Curt, will present an interim update based on six month data for
the first six subjects at the <I>American Spinal Injury Association </I>conference this coming May. Final
results from this landmark study are expected to be released mid-2015.
</FONT>

<P align="left" style="font-size: 10pt">&#147;This is the first clinical trial evaluating stem cell transplantation in spinal cord injury to
successfully complete enrollment. Successful dosing of all subjects in the trial is a major
accomplishment for the field and the spinal cord injury program at StemCells, Inc.,&#148; said Stephen
Huhn, M.D., FACS, FAAP, Vice President, CNS Clinical Research at StemCells, Inc.


<P align="left" style="font-size: 10pt">&#147;I have the utmost respect for all of the brave patients, their families and caregivers who have
been open to participating in this study. There is a large unmet medical need for patients
suffering from spinal cord injury, and completion of all transplantations in this trial signifies
an important inflection point in the pace of our development. This clinical research milestone
moves us one step closer to our goal of developing a first in class therapy for this indication
based on our proprietary HuCNS-SC platform technology.&#148;


<P align="left" style="font-size: 10pt">The study, initiated at the University of Zurich under Dr.&nbsp;Armin Curt, subsequently expanded to
include two sites in Canada and also received an Investigational New Drug (IND)&nbsp;authorization from
the U.S Food and Drug Administration (FDA).


<P align="left" style="font-size: 10pt">&#147;Having been involved with this trial from the very beginning, I have a sense that the research is
now starting to accelerate and we are very pleased to have played a role in this groundbreaking
trial,&#148; said Armin Curt, MD, the principal investigator at the University of Zurich.


<P align="left" style="font-size: 10pt">Steve Casha, M.D., Ph.D., FRCSC, the principal investigator at the University of Calgary, added,
&#147;We completed the surgical transplantation of the final patient yesterday and clinical studies like
this one are very important to patients affected by spinal cord injury. I am very excited by the
prospect of participating in the next phase of clinical research where the goal is to demonstrate
efficacy in a Phase II placebo controlled clinical trial.&#148;


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

<P align="left" style="font-size: 11pt"><FONT style="font-size: 10pt">The Company&#146;s Phase I/II clinical trial is designed to assess both safety and preliminary
efficacy of HuCNS-SC cells as a treatment for chronic spinal cord injury. The Company enrolled 12
subjects with thoracic (chest-level) neurological injuries at the T2-T11 level, classified as
complete or incomplete according to the American Spinal Injury Association Impairment Scale.&nbsp;
</FONT>

<P align="left" style="font-size: 10pt">Each of the first three subjects suffered a complete injury prior to enrolling in the study. Twelve
months after transplantation of the HuCNS-SC cells, data showed multi-segment gains in sensory
function in two of the first three subjects, one of which converted from a complete to an
incomplete injury.&nbsp;The third subject in this cohort remained stable, 12&nbsp;months after
transplantation.&nbsp;


<P align="left" style="font-size: 10pt">The trial enrolled spinal cord injury patients at three centers: the University of Calgary, the
University of Toronto, and University of Zurich&#146;s Balgrist University Hospital, world-leading
medical centers for spinal cord injury and rehabilitation.


<P align="left" style="font-size: 10pt">All subjects who enrolled in the trial received HuCNS-SC cells through direct transplantation into
the spinal cord and underwent temporary treatment with immunosuppressive drugs.&nbsp;Evaluations have
been, and will continue to be, performed regularly throughout 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 change in neurological function.&nbsp;Preliminary efficacy will be evaluated
based on defined clinical endpoints, such as changes in sensation, motor function and bowel/bladder
function.&nbsp;The Company intends to follow the effects of this intervention long-term, and each of the
subjects will be invited to enroll in a separate four-year observational study after completing the
Phase I/II study.&nbsp;In addition, the Company plans to initiate a controlled Phase II trial designed
to measure efficacy in cervical spinal cord injury in 2014.


<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="margin-left:1%; font-size: 10pt"><U>http://www.stemcellsinc.com/Therapeutic-Programs/Spinal-Cord-Injury.htm </U>


<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 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.&nbsp;The Company conducted a Phase
I/II clinical trial in chronic spinal cord injury in Switzerland, Canada and the United States, and
has reported positive interim data for the first three patients.&nbsp;The Company is also conducting a
Phase I/II clinical trial in dry age-related macular degeneration (AMD)&nbsp;in the United States. In
addition, the Company is pursuing preclinical studies in Alzheimer&#146;s disease, with support from the
California Institute for Regenerative Medicine (CIRM).&nbsp;&nbsp;StemCells also markets stem cell research
products, including media and reagents, under the SC Proven&#174; brand.&nbsp;Further information about
StemCells is available at <U>http://www.stemcellsinc.com</U>.
</FONT>

<P align="left" style="font-size: 10pt"><FONT 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 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;
the prospect for initiating a Phase II clinical study in cervical spinal cord injury; 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
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 manufacture viable cells
sufficient to enroll the patients planned for the Company&#146;s Phase II studies; 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; and other
factors that are described under the heading &#147;Risk Factors&#148; in the Company&#146;s Annual Report on Form
10-K for the year ended December&nbsp;31, 2013, and in its subsequent reports on </I><I>Form 10-Q</I><I> and </I><I>Form 8-K</I><I>.</I>
</FONT>

<P align="left" style="font-size: 11pt"><FONT style="font-size: 10pt"><B>CONTACT: </B>Greg Schiffman
</FONT>

<P align="left" style="font-size: 10pt; text-indent: 5%">StemCells, Inc.


<P align="left" style="font-size: 10pt; text-indent: 5%">Chief Financial Officer


<P align="left" style="font-size: 10pt; text-indent: 5%">(510)&nbsp;456-4128


<P align="left" style="font-size: 10pt; text-indent: 5%">Andrea Flynn


<P align="left" style="font-size: 10pt; text-indent: 5%">Russo Partners


<P align="left" style="font-size: 10pt; text-indent: 5%">(646)&nbsp;942-5631



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




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