<SEC-DOCUMENT>0001299933-15-000905.txt : 20150605
<SEC-HEADER>0001299933-15-000905.hdr.sgml : 20150605
<ACCEPTANCE-DATETIME>20150604183552
ACCESSION NUMBER:		0001299933-15-000905
CONFORMED SUBMISSION TYPE:	8-K
PUBLIC DOCUMENT COUNT:		3
CONFORMED PERIOD OF REPORT:	20150604
ITEM INFORMATION:		Other Events
ITEM INFORMATION:		Financial Statements and Exhibits
FILED AS OF DATE:		20150605
DATE AS OF CHANGE:		20150604

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:		15914054

	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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	June 4, 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>
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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
<BR>______________________________________________<BR>
	Former name or former address, if changed since last report
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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>
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	Item 8.01 Other Events.
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Earlier today, StemCells, Inc. (the "Company") issued a press release announcing enrollment of its first subject in Cohort 2 of its Phase II Pathway Study.<br> <br>The Phase II Pathway Study is designed to assess the efficacy of the Company&#x2019;s proprietary HuCNS-SC&#174; purified human neural stem cells for the treatment of cervical spinal cord injury. Cohort 2 will enroll 40 patients and forms the single-blinded controlled arm of the Phase II study. The primary efficacy outcome being tested in Cohort 2 is the change in motor strength of the various muscle groups in the upper extremities innervated by the cervical spinal cord.  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><br>Exhibit 99.1 Press Release, dated June 4, 2015, announcing enrollment of its first subject in Cohort 2 of its Phase II Pathway 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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	June 4, 2015
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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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Press Release dated June 4, 2015
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<P align="center" style="font-size: 10pt"><FONT style="font-size: 12pt"><B>StemCells, Inc. Announces Commencement of the Second Cohort of the Pathway&#153; Study in Cervical<BR>
Spinal Cord Injury</B></FONT>



<P align="center" style="font-size: 12pt"><I>Phase II Study Designed to Assess the Potential of Human Neural Stem Cells<BR>
to Restore Motor Function</I>



<P align="center" style="font-size: 12pt"><I><img src="e41515-15155114753313b971_2.jpg"></I>



<P align="left" style="font-size: 12pt"><FONT style="font-size: 10pt"><B>NEWARK, CA, June&nbsp;4, 2015 </B>(GLOBE NEWSWIRE) &#151; StemCells, Inc. (Nasdaq:STEM), a world leader in
the research and development of cell-based therapeutics for the treatment of central nervous system
diseases and disorders, announced today that it has enrolled its first subject in Cohort 2 of its
Phase II Pathway Study. The study is designed to assess the efficacy of the Company&#146;s proprietary
HuCNS-SC<sup>&#174;</sup> platform technology (purified human neural stem cells) for the treatment of
cervical spinal cord injury. Cohort 2 will enroll 40 patients and forms the single-blinded
controlled arm of the Phase II study. The primary efficacy outcome being tested in Cohort 2 is the
change in motor strength of the various muscle groups in the upper extremities innervated by the
cervical spinal cord.
</FONT>

<P align="left" style="font-size: 10pt">The Pathway Study is the first clinical trial designed to evaluate both the safety and efficacy of
human neural stem cells transplanted into the spinal cord of patients with cervical spinal cord
injury. Traumatic injuries to the neck can damage the cervical spinal cord and result in impaired
sensation and motor function of the arms, legs, and trunk, also referred to as quadriplegia. The
trial has 3 cohorts. The primary Cohort is Cohort 2 which is being conducted as a randomized,
controlled, single-blind Cohort and efficacy will be primarily measured by assessing motor function
according to the International Standards for Neurological Classification of Spinal Cord Injury
(ISNCSCI). The trial will follow the participants for one year and will enroll up to 52 subjects.


<P align="left" style="font-size: 10pt">Cohort 1 of the Pathway Study is an open-label, HuCNS-SC dose-escalation arm involving six
patients. Safety data from all six subjects was reviewed by an independent Data Monitoring
Committee and approval was provided to commence with Cohort 2. No safety or tolerability issues
were seen at any of the dosing levels. The six-month outcome from Cohort 1 will be disclosed as
interim data later this year.


<P align="left" style="font-size: 10pt">Cohort 3 is an optional open label Cohort targeted to enroll 6 patients. This Cohort is designed to
assess safety and preliminary efficacy in patients with less severe injuries (AIS C).


<P align="left" style="font-size: 10pt">&#147;The initiation of Cohort 2 begins the next phase of our clinical efforts towards a potential
breakthrough therapy for spinal cord injury,&#148; said Stephen Huhn, M.D., FACS, FAAP, Vice President,
Clinical Research and Chief Medical Officer at StemCells, Inc. &#147;This is the first blinded,
controlled clinical trial to be conducted using human neural stem cells. The goal of this
proof-of-concept study is to demonstrate the potential efficacy of our cells as a treatment for
victims of spinal cord injury. We currently have seven sites enrolling patients and expect to reach
a total of fourteen active North American sites by year end. Conducting a multi-center study on
this scale should allow us to efficiently enroll the study.&#148;


<P align="left" style="font-size: 10pt">The Company completed enrollment and dosing in its open-label Phase I/II study in thoracic spinal
cord injury in April&nbsp;2014 and has reported top-line results. Sustained post-transplant gains in
sensory function were demonstrated in seven of the twelve patients. Two patients in the Phase I/II
study converted from a complete injury (AIS A) to an incomplete injury (AIS B). The final results
also continue to confirm the favorable safety profile of the cells and the surgical procedure.


<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 Company&#146;s Phase II Pathway 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. 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 and was designed to establish the
cell dose for onward testing in the second cohort of the study.
</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 </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


<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>
