<SEC-DOCUMENT>0001299933-15-000781.txt : 20150514
<SEC-HEADER>0001299933-15-000781.hdr.sgml : 20150514
<ACCEPTANCE-DATETIME>20150514171048
ACCESSION NUMBER:		0001299933-15-000781
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		2
CONFORMED PERIOD OF REPORT:	20150505
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20150514
DATE AS OF CHANGE:		20150514

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:		15863924

	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 5, 2015
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	StemCells, Inc.
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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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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>
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	Item 8.01 Other Events.
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Earlier today, StemCells, Inc. (the "Company") issued a press release announcing top-line positive results from its Phase I/II trial in thoracic spinal cord injury.<br> <br>The Company&#x2019;s international, open-label, Phase I/II trial evaluated both safety and preliminary efficacy of its proprietary HuCNS-SC human neural stem cells as a treatment for chronic spinal cord injury.  The trial enrolled twelve patients who had suffered injury to the thoracic cord and were in the early chronic stage of recovery. The analysis of the study demonstrated that the surgical transplantation technique and cell dose were safe and well tolerated by all patients. In addition to safety, analysis of the twelve-month data revealed sustained improvements in sensory function that emerged consistently around three months after transplantation and persisted until the end of the study. A copy of the press release is attached hereto as Exhibit 99.1.<br>
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	Item 9.01 Financial Statements and Exhibits.
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(d) Exhibit<br>Exhibit 99.1 Press Release, dated May 14, 2015, announcing positive results from the Company&#x2019;s thoracic spinal cord injury Phase I/II Study.<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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	May 5, 2015
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	Kenneth Stratton
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	Name: Kenneth Stratton
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(d) Exhibits
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<P align="center" style="font-size: 10pt"><FONT style="font-size: 12pt"><BR>
<B>StemCells, Inc. Announces Positive Top-Line Results of its Thoracic Spinal Cord Injury Phase I/II<BR>
Study</B></FONT>



<P align="center" style="font-size: 12pt"><FONT style="font-size: 11pt"><I>Sensory gains demonstrate the clinical effect of HuCNS&#150;SC</I><sup><I>&#174;</sup> transplantation<BR>
Results hold promise for Phase II Pathway</I><sup><I>TM</sup> cervical spinal cord injury study</I></FONT>



<P align="left" style="font-size: 11pt"><FONT style="font-size: 10pt"><B>NEWARK, CA, May&nbsp;14, 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, announced today that Dr.&nbsp;Armin Curt, principal investigator, will present a summary of the
safety and preliminary efficacy data from the Phase I/II study investigating</FONT><FONT style="font-size: 11pt"> </FONT><FONT style="font-size: 10pt">Human
Central Nervous System Stem Cell (HuCNS-SC) intramedullary transplantation in thoracic spinal cord
injury. The summary will be presented today at 10:15&nbsp;a.m. EDT at the 4<sup>th</sup> Joint
International Spinal Cord Society (ISCoS) and American Spinal Injury Association (ASIA)&nbsp;meeting
being held in Montreal, Canada. The abstract was selected as one of the top six platform
submissions for the conference.
</FONT>

<P align="left" style="font-size: 10pt">The international, open-label, Phase I/II trial evaluated both safety and preliminary efficacy of
StemCells, Inc.&#146;s proprietary HuCNS-SC human neural stem cells as a treatment for chronic spinal
cord injury. The trial enrolled twelve patients who had suffered injury to the thoracic cord and
were in the early chronic stage of recovery. The severity of spinal cord trauma is classified by
the ASIA Impairment Scale (AIS)&nbsp;according to the degree of sensory and motor loss. Patients
classified as AIS A, the most severe injury, have lost both sensory and motor function below the
level of injury. AIS B patients are considered less severely injured because, although they also
have no motor function below the level of injury, some limited sensory function is maintained. The
protocol was specifically designed to test safety and preliminary efficacy across this spectrum of
injury severity, and ultimately the trial transplanted seven AIS A and five AIS B patients.


<P align="left" style="font-size: 10pt">The analysis of the study demonstrated that the surgical transplantation technique and cell dose
were safe and well tolerated by all patients. HuCNS-SC cells were injected directly into the cord
both above and below the level of injury and sequential examinations of the patients over the
course of twelve months showed no abnormal changes in spinal cord function associated with the
transplantation technique. There were no adverse events attributed to the HuCNS-SC cells.


<P align="left" style="font-size: 10pt">In addition to safety, analysis of the twelve-month data revealed sustained improvements in sensory
function that emerged consistently around three months after transplantation and persisted until
the end of the study. The patterns of sensory gains were confirmed to involve multiple sensory
pathways and were observed more frequently in the patients with less severe injury; three of the
seven AIS A patients and four of the five AIS B patients, showed signs of positive sensory gains
confirming the previously released interim results. In addition, two patients progressed during the
study from the most severe classification, AIS A, to the lesser degree of injury grade, AIS B.


<P align="left" style="font-size: 10pt">&#147;It has been a privilege to be a part of the first study to test the potential of neural stem cell
transplantation in thoracic spinal cord injury,&#148; said Dr.&nbsp;Armin Curt, Professor and Chairman of the
Spinal Cord Injury Center at Balgrist University Hospital, University of Zurich. &#147;The gains we have
detected indicate that areas of sensory function have returned in more than half the patients. Such
gains are unlikely to have occurred spontaneously given the average time from injury. This patient
population represents a form of spinal cord injury that has historically defied responses to
experimental therapies, and the measurable gains we have found strongly argue for a biological
result of the transplanted cells. These gains are exciting evidence that we are on the right track
for developing this approach for spinal cord injury. This early outcome in thoracic injury firmly
supports testing in cervical spinal cord injury.&#148;


<P align="left" style="font-size: 10pt">Stephen Huhn, M.D., FACS, FAAP, Vice President, Clinical Research and CMO at StemCells, Inc., said,
&#147;This research program has the potential to revolutionize the therapeutic paradigm for spinal cord
injury patients. The clinical gains observed in this first study are a great beginning. We found
evidence of sensory gains in multiple segments of the injured thoracic spinal cord across multiple
patients. Our primary focus in this study for spinal cord injury was to evaluate safety and also to
look for even small signs of an effect that went beyond the possibility of spontaneous recovery. We
are obviously very pleased that the pattern of sensory gains observed in this study are both
durable and meaningful</FONT><FONT style="font-size: 9pt">,</FONT><FONT style="font-size: 10pt"> and indicate that the transplantation has impacted the function of
damaged neural pathways in the cord. The Company&#146;s development program has now advanced to a Phase
II controlled study in cervical spinal cord injury where the corollary of sensory improvements in
thoracic spinal cord injury could well be improved motor function in the upper extremities of
patients with cervical spinal cord injuries.&#148;
</FONT>

<P align="left" style="font-size: 10pt"><FONT style="font-size: 11pt"><B>About the StemCells, Inc. Thoracic 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 was 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 T2-T11 level (chest-level) neurological injuries classified as either AIS A
or B according to the ASIA Impairment Scale (AIS)&nbsp;who were a minimum of 3&nbsp;months from injury.&nbsp; Both
AIS A and B are considered to have complete loss of motor function below the level of injury, but
AIS B subjects have some degree of preserved sensory function below the level of injury.
</FONT>

<P align="left" style="font-size: 10pt">The trial involved three world-leading medical centers for spinal cord injury and rehabilitation,
and associated principal investigators; Dr.&nbsp;Armin Curt at the University of Zurich and Balgrist
University Hospital, Dr.&nbsp;Steve Casha at the University of Calgary, and Dr.&nbsp;Michael Fehlings at the
University of Toronto.


<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 were
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 was evaluated based on defined clinical endpoints using
established spinal cord injury scales assessing changes in sensory and motor function. Patients
were enrolled in a separate observational study after completing the twelve-month Phase I/II trial.


<P align="left" style="font-size: 10pt">Enrollment included seven AIS A and 5 AIS B patients. The study showed a favorable safety,
feasibility and tolerability profile with no adverse events associated to the HuCNS-SC cells.
Twelve months after transplantation of the HuCNS-SC cells, data showed gains in sensory function in
three of the seven AIS A patients and four of the five AIS B patients. In addition, two patients
progressed from the most severe classification, AIS A, to a lesser degree of injury grade, AIS B.


<P align="left" style="font-size: 10pt">In follow-up to the thoracic study, the Company has initiated a Phase II trial designed to measure
efficacy in cervical spinal cord injury. The Phase II trial, also called the Pathway study, is a
controlled study and was initiated in late 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="font-size: 10pt"><U>http://www.stemcellsinc.com/Clinical-Programs/SCI</U>


<P align="left" style="font-size: 10pt"><FONT style="font-size: 11pt"><B>About the Pathway Cervical 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. The first cohort of six patients completed
enrollment in April. This is a dose confirmation cohort. The results from this cohort will
determine the cell dosage to be used for the remainder of the study. The six-month interim data
from this cohort will be disclosed later this year.
</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 in humans, 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 HuCNS-SC<sup>&#174;</sup>
platform technology (purified human neural stem cells) as a potential treatment for disorders of
the central nervous system (CNS). Top line data from the Company&#146;s Phase I/II clinical trial in
thoracic spinal cord injury (SCI)&nbsp;showed 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. In addition to the completion
of the Phase I/II thoracic SCI study and the ongoing Pathway study, StemCells, Inc. has completed
enrollment in its Phase I/II clinical trial in geographic atrophy of age-related macular
degeneration (GA-AMD), the most severe form of dry AMD and the leading cause of blindness in the
elderly. Based upon interim results for patients who had completed twelve months of follow-up, the
Company reported reductions in the rate of progression in GA as compared to the untreated eye and
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 by MRI.&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 ability of HuCNS-SC cells to restore sensory function in patients with chronic
spinal cord injury; the prospect for continued clinical development of the Company&#146;s HuCNS-SC cells
in CNS disorders; and the likelihood that early signs of clinical efficacy can be replicated in
future clinical 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 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


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