Full Press Release Details
World Leader in Neural Stem Cell Science Corporate Overview February 2013
Safe Harbor statements under the Private Securities Litigation Reform Act of 1995 : This presentation contains forward - looking statements as defined in Section 27 A of the Securities Act of 1933 as amended, and section 21 E of the Securities Exchange Act of 1934 , as amended . Such forward - looking statements are based upon Neuralstem , Inc . 's management's current expectations, estimates, beliefs, assumptions, and projections about Neuralstem's business and industry . Words such as "anticipates," "expects," "intends," "plans," "predicts," "believes," "seeks," "estimates," "may," "will," "should," "would," "potential," "continue," and variations of these words (or negatives of these words) or similar expressions, are intended to identify forward - looking statements . In addition, any statements that refer to expectations, projections, or other characterizations of future events or circumstances, including any underlying assumptions, are forward - looking statements . These forward - looking statements are not guarantees of future performance and are subject to certain risks, uncertainties, and assumptions that are difficult to predict . Therefore, our actual results could differ materially and adversely from those expressed in any forward - looking statements as a result of various risk factors . These risks and uncertainties include the risks associated with the effect of changing economic conditions, trends in the products markets, variations in Neuralstem's cash flow, market acceptance risks, technical development risks and other risk factors detailed in Neuralstem's Securities and Exchange Commission filings . For links to SEC documents please visit the company's Web site : neuralstem . com . Safe Harbor
Overview Industry Firsts Inventor of human neural stem cell technology is Karl Johe , Ph.D., Chairman and Chief Scientific Officer, while at NIH First FDA - approved neural stem cell therapy trials for ALS & chronic spinal cord injury First - in - class hippocampal neurogenic small molecule drug portfolio Platform Technology Regionally specific, fully characterized CNS human neural stem cells, cGMPmnfr . 2 programs: 1) cell therapy direct injection, brain and spinal cord, 2) neurogenic small molecule development screening 9 U.S. patents re - affirmed worldwide - technology and product; 22 pending Cell Therapy - Lead Product: NSI - 566 Huge unmet medical needs include ALS, spinal cord injury, stroke FDA Phase I safety approval of cells and surgical device Data shows signs of efficacy; definitive evidence of long - term cell survival First Phase I completed - ALS; FDA - approved SCI Phase I; accelerated int'l trials World - class collaborators Small Molecule - Lead Product: NSI - 189 Huge medical markets include depression, CTE and PTSD Novel "hippocampus builder" initially funded by DOD program, early mover advantage FDA - approved Phase I safety proved; Ib testing escalating doses, in MDD Partnership with biotech or big pharma expected 3
1 2 - Month Clinical Trial Catalysts NSI - 566/ALS Phase II U.S. Trial NIH - major funding Increased dosing, all cervical Dual center, accelerated timeline Data 6 months after final surgery Orphan Status Designation Est. 30,000 ALS patients, est. 5,600 diagnosed per year, U.S. Phase I/II Mexico City Trial Accelerated timeline and approvals Pending partnership agreement NSI - 566/Chronic Spinal Cord Injury Phase I U.S. Trial FDA Approved Jan 2013 Same Cells, Procedure as ALS One - year timeline goal Multiple sites, agreements expected 1Q13 Est. 840K SCI patients, 10K+ new SCI injuries per year, U.S. Phase I/II Seoul Trial Partner CJ CheilJedang Acute SCI patients IND expected 1Q13, trial mid - year NSI - 566/Ischemic Stroke ( Neuralstem China) Phase I/II China Trial World - class Bayi Brain Hospital Same Cells, injected in brain Phase I - determine max safe dose, up to 18 Patients Phase II - 100 patients, efficacy China stroke pop est : 1.75 million+ NSI - 189/Major Depressive Disorder Phase Ib Data, MDD patients Phase II application Partnership deal with Biotech or Big Pharma Est. 14.8 million MDD patients, U.S. NSI - 189 proven safe in Phase I; add'l applications expected to commence testing at Phase II 4
Neuralstem Technology - Cells Nurturing, Supporting and Rescuing Remaining Neurons Regionally specific CNS neural stem cells: brain and spinal cord 9 U.S. p atents re - affirmed worldwide, 22 pending cGMP manufacturing Numerous cell therapy stem cell products Fully characterized Expanded under defined conditions: no animal - derived reagents, serum or feeder cells Reproducible differentiation: constitutive behavior of cells Physiologically relevant neurons: 50% 5 Midbrain Dopaminergic Spinal Cord Cholingergic Hippocampus GABAergic
Single Platform Technology, Two Programs, Multiple Indications Ischemic Spastic Paraplegia Amyotrophic Lateral Sclerosis Optic Neuritis Lysosomal Diseases Ischemic Stroke Alzheimer's Disease Parkinson's Disease Spinal Cord Injury Traumatic Brain Injury Huntington's Disease Glioblastoma (Brain Cancer) Peripheral Nerve Injury Cerebral Palsy Multiple Sclerosis Diabetic Neuropathy Ischemic Spastic Paraplegia Major Depressive Disorder Post - Traumatic Stress Disorder Alzheimer's Disease CTE - Chronic Traumatic Encephalopathy Cognitive complication due to Diabetes Neurodegeneration Stroke Anti - Aging ( Nootropic ) Traumatic Brain Injury 6 Current Human Clinical Trials Pre - clinical Applications
NSI - 566 Human Proof of Concept, Safety, and Signs of Efficacy Successful , safe injection of neural stem cells 15 patients, 18 surgeries L umbar and/or cervical regions of spinal cords No complications related to cell delivery No toxicity related to cells Definitive evidence of long - term cell survival via DNA fingerprinting " With the transplantation of these neural stem cells, we are exploring a paradigm shift in the treatment of ALS. We have demonstrated that intraspinal transplantation is feasible and well - tolerated. Although this phase of the trial was not powered to demonstrate efficacy, we appear to have interrupted the progression of the disease in one subgroup of patients. We are anxious to move to future trial phases to examine therapeutic efficacy." Principal Investigator: Eva L. Feldman, M.D., Ph.D. Professor of Neurology & Director, A. Alfred Taubman Medical Research Inst. of the University of Michigan Medical School; President of American Neurological Association 7 Amyotrophic Lateral Sclerosis Ischemic Stroke Spinal Cord Injury
ALS - Amyotrophic Lateral Sclerosis NSI - 566 FDA Orphan Designation No C ure Unmet Medical Need: Est. 30,000 Americans have disease at any given time (ALSA) Est. 5,600+ people diagnosed each year in the U.S. (ALSA) Est. n early 120,000 cases diagnosed worldwide each year (Int'l Alliance of ALS/MND Assns . ) Progressive neurodegenerative disease Affects nerve cells in the brain and spinal cord Leads to complete paralysis, and eventually, death "Now this is a disease that doesn't get better. So we don't see patients who spontaneously get better. It just doesn't happen." -- Neuralstem ALS Trial Site Principal Investigator and Emory University neurologist Dr . Jonathan Glass, referring to pre - trial disease status 8
NSI - 566/ALS Phase I Success: Proven Safe, Signs of Efficacy Five of six ambulatory patients showed improvement or very slow progression of the disease post surgery Nonambulatory Cohorts ( Patients 1 - 6) Ambulatory Cohorts (Patients 6 - 12 ) ALS Functional Rating Scale - Revised ( ALSFRS - R) monitors changes in a patient over time with ten measures including speech , swallowing , walking and breathing, total score of 48. 0 baseline: Treatment Forced Vital Capacity (FVC) is a lung function test that measures total lung capacity by the amount of gas contained in the lung at the end of a maximum inhalation. 0 baseline: Treatment Hand - Held Dynamometer (HHD) reflects the muscle strength. 0 baseline: Treatment All: Glass , et. al. STEM CELLS 2012;30:1144 - 1151 9 ALSFRS - R
Neuralstem ALS Patient Story: TED HERADA - Patient 12 Surgery #12 (lumbar) - Reversed ALS Progression 39 years old, ALS diagnosed 2009 1 st treatment March 2011 - lumbar (lower spinal cord) 10 injections, bilateral, 100,000 cells per 4 - hour procedure, therapy well - tolerated Walking without cane; limb strength and dexterity greatly surpassed pre - treatment ability Maintained this unheard - of degree of ALS recovery approx. one year, until gradual decline started and continued until second treatment: Surgery #18 (cervical and lumbar) - Completes 2.5 - mile ALS Walk 2 nd treatment August 2012 - final trial surgery 5 injections, cervical (upper spinal cord), 100,000 cells per 6 - hour procedure, therapy well - tolerated Functional Recovery repeats: two months after treatment, Ted completes 2.5 - mile fundraising ALS walk in Atlanta - still going strong past finish line Living a normal life: walking, climbing stairs, hands stronger again, increased dexterity 10
NSI - 566/ALS - Next Phase: Increase Dosage, Evaluate Efficacy and Safety U.S. Phase II expected to commence in second half of 2013 Emory announced significant NIH grant to cover majority of Phase II trial cost Pending FDA approval of new protocol; IND filed 4Q12; official Phase I completion date mid - Feb 2013 Collaborators: Eva L. Feldman, M.D., Ph.D. and Jonathan D. Glass, M.D. Goal: maximum safe tolerated dose; evaluate e fficacy for clinical proof - of - concept to advance to Phase III 15 - 16 ambulatory patients Accelerated dosing schedule, cervical injections 100,000 - 300,000 cells per injection 5 - 20 injections, escalated dosing per cohort (requested protocol) Dual centers , escalated timeline Emory University Hospital A. Alfred Taubman Medical Research Inst. of the University of Michigan Medical School 6 - month observation period from last surgery to trial completion 11
Spinal Cord Injury - Neuralstem Cells To "Bridge the Gap" Unmet Medical Need: Approximately 840,000 SCI patients in the U.S. (NSCIA) 10,000+ new spinal cord injuries each year in the U.S. (NSCIA) 85% of SCI patients who survive first 24 hours are alive ten years later (NSCIA) Affects nerve cells in the spinal cord Spinal cord damage results in loss of function such as mobility, feeling Chronic spinal cord injury ( cSCI ): some level of paralysis that persists for a long duration, and is usually defined as more than one year following injury Complete cSCI : no function below the injury; no sensation, no voluntary movement Acute SCI: early stage of injury, having rapid onset and usually with some recovery 12
NSI - 566/SCI Trials - Same Cells and Procedure U.S. - NSI - 566/ cSCI Phase I Expected to Commence in 2 nd Half of 2013 FDA approved trial in January 2013 One - year Phase I completion goal ; trial study period ends six months post - surgery for each patient Principal investigator: Keith Tanney , M.D., Ph.D., Shepherd Center Seoul - NSI - 566/Acute SCI Phase I with Partner CJ CheilJedang , IND Expected 1Q13 Trial expected to start in 2 nd half of 2013 - four sites, following Korea Food and Drug Administration (KFDA) approval of trial Goal is return of motor/sensory function to patients South Korean partner CJ CheilJedang , whose pharma division has 1,200 employees and $400 million USD annual revenue from a wide breadth of products, has exclusive option agreement for cell therapy products in six South Asian countries : South Korea, Indonesia, Malaysia, Philippines, Singapore and Vietnam 8 cSCI patients T2 - T12 injuries - complete thoracic, no cervical American Spinal Injury Assn. (ASIA) level A impairment - complete paralysis - one - to - two years post - injury Multiple centers ( 4) - clinical trial institution agreements expected 1Q13 All dosing completed six months from trial commencement Six injections in, or around, the injury site 100,000 cells per, first four patients; 200,000 cells per, second four patients Primary objective : safety and toxicity of NSI - 566 Secondary e ndpoints: evaluate graft survival in the transplant site by MRI; effectiveness of transient immunosuppression . Exploratory objectives include: evaluate ability of NSI - 566 transplantation to positively affect AIS level, ISNC SCI motor and sensory index scores, bowel and bladder function, pain, UAB IMR scores, SCIM scores, evoked sensory and motor potentials, and electromyogram (EMG) Patients to receive physical therapy post - surgery to guide newly formed nerves to proper connections & functionality Patients to also receive immunosuppressive therapy, which will be for three months, as tolerated 13
Ischemic Stroke Stroke is 4 th - leading cause of death in U.S. (NSA) Stroke is a leading cause of adult disability (NSA) Unmet Medical Need: Est. 7,000,000 Americans have survived a stroke (NSA) Est. 1,750,000 people in China alone, per year, survive a stroke 87% of stroke cases are ischemic stroke (ASA, NSA) 2/3+ stroke survivors have some type of disability (NSA) Occurs as a result of an obstruction within a blood vessel supplying blood to the brain Affects nerve cells in the brain Post - stroke motor deficits include paralysis in arms and legs, and can be permanent 14
NSI - 566/Ischemic Stroke - Rebuilding Neural Circuitry and Promoting Repair and Recovery of Surviving Tissue Combined Phase I / II Trial expected to commence in 1Q13 - approved September 2012 Wholly owned subsidiary: Neuralstem China ( Suzhou Neuralstem Biopharmaceutical Company, Ltd.) Collaborator: BaYi Brain Hospital, in Beijing, world - class research facilities and one of China's premier neurological hospitals Expected duration : approximately two years, combined Phase I/ II/III study, including patient monitoring and data collection 15 Trial protocol developed for FDA approval in the U.S., advanced preclinical program One - time treatment of direct intracerebral injections of cells into the stroke area, using well - accepted stereotactic injection procedures Up to 118 Patients: ischemic stroke with chronic residual motor disorder, 4 to 24 months post - stroke Phase I: safety , determine m aximum safe dose Open - label , up to 18 patients assigned to three cohorts Each cohort receives ascending doses of NSI - 566: 3 - 5 deposits on each of 5 tracks 40,000 - 80,000 cells per deposit Phase II/III: proof - of - concept , evaluates efficacy and safety Multi - site, r andomized , controlled , single - blind study Up to 100 stroke patients with stable paralysis for at least four months 50 % receive one - time treatment, with physical therapy 50 % receive physical therapy with no surgery Outcome measures conducted in single - blinded manner
NSI - 566 Cell Therapy - Additional Applications Glioblastoma (Brain Cancer ) Research program initiated with U.S. DOD funding: $1.6 M award Preclinical: Developing and Engineering neural stem cell technology to express anti - cancer agents Collaborator: John H. Zhang, M.D. Ph.D., Loma Linda University Multiple Indications - Further clinical development pending NSI - 566 ALS Phase I Data, ongoing trial Multiple Sclerosis - est. 2.5 million worldwide, 400,000 U.S. (NMSS) Optic Neuritis - rare Alzheimer's Disease -- est. 5.4 million U.S. (AA/Alzheimer's Assn ) Traumatic Brain Injury - est.1.7 million U.S. per year; approx. 5.3 million live with disability in U.S. alone (AANS) Peripheral Nerve Injury - extensive, 100+types, network of 43 pairs of motor and sensory nerves Diabetic Neuropathy - affects approx. 60 % of est. 25.8 million both type 1 and type 2 diabetes patients (ADA) Lysosomal Diseases - rare, varies; group of 50 distinct genetic diseases (NCBI, NIH) Parkinson's Disease - est. 1.5 million Americans, with est. 60K new cases per year (AANS) Huntington's Disease - est. 30,000 U.S. (HDSA) Cerebral Palsy - est. 764K U.S. (CP) Ischemic Spastic Paraplegia - can result from complication from surgery to repair aortic aneurysms 16
NSI - 566/ALS Completed Phase I Data Propels Additional Trials Development Pipeline - Clinical Trials Status 18 Development Phase I Phase II Phase III ALS U.S. IND Sub: Dec 2012 Expect to initiate Phase II in 1Q13 ALS Mexico Combined Phase I/II, pending partnership agreement cSCI U.S. FDA Approval: Jan 2013 Expect to initiate Phase I in 2Q13 Acute SCI S. Korea IND expected 1Q13 Mid - year trial start Ischemic Stroke China Expected Phase I start 1Q13 Moves to II within 6 months NSI - 566
First - in - class Neurogenic Small Molecule Drugs - Reverse Hippocampal Atrophy "War Fighter of the Future" DOD program, initial funding Patented Novel Neurogenic Compounds 100% owned for commercialization Early mover advantage NSI - 189: Lead Compound R ecruit endogenous neural stem cells to generate more new neurons in adult brain NSI - 189 Lead drug candidate: Increases hippocampal volume - +> 20% in animal studies Rebuilds hippocampus structurally Enhances neurogenesis Small Molecule Discovery and Development Enabled by Proprietary Stem Cell - based Screening 18
Major Depressive Disorder (MDD) NSI - 189 Lead Drug Candidate First Application Challenging Medical Need: Est. 14.8 million American adults (NIMH) Leading Cause of Disability in U.S. for ages 15 - 44 (NIMH) New Theory of How To Treat: Brain physiology in the disease rather than brain chemistry alone Researchers now know depressed patients have reduced hippocampal volume NSI - 189, by stimulating the generation of new neurons in the hippocampus, could potentially address the pathology of the depression itself Current MDD oral medications, including worldwide - widely prescribed selective serotonin reuptake inhibitors, modulate levels of different neurotransmitters in the brain MDD, also termed "major depression": combination of symptoms interferes with ability to work, sleep, study, eat, and enjoy once - pleasurable activities 19
NSI - 189/MDD - Phase Ib Escalated Dosing, Topline Data Expected 2Q13 Established drug safety in Phase Ia h ealthy volunteers : 41 volunteers received escalating doses of single oral administration (completed October 2011 ) Psychiatric clinical trial consultant : Maurizio Fava, M.D., Slater Family Professor of Psychiatry at Harvard Medical School and Executive Vice Chair of the Department of Psychiatry at Massachusetts General Hospital 20 Ongoing Phase Ib commenced June 2012; est. completion 1Q13; topline data expected 2Q13 Randomized, double - blind, placebo - controlled, multiple - dose escalating trial. 24 patients with recurrent MDD: three sets of eight patients (six treated, two placebo per set) Escalating dose per set, daily for 28 days: 40 mg. q.d ., 40 mg. b.i.d ., 40 mg. t.i.d . Two - month recovery follow - up, including MRI to monitor hippocampal volume Secondary Phase Ib Endpoints: Tolerability Pharmacokinetics Pharmacodynamic effects - hippocampal volume by MRI, BDNF/CRH/other factors in blood, urine biomarkers, cortisol in saliva, qEEG , MADRS, NGH Depression Questionnaire, Columbia Suicidal Rating
NSI - 189/MDD - Next Phase Development Partnering Development Partner - Actively pursuing partnership for large - scale NSI - 189 ramp - up expected in 2013 Phase II, III, and commercialization: MDD, broad range of psychiatric and cognitive disorders Locust Walk Partners, a life sciences' commercial licensing and partnering specialist advisory firm, brokering deal; discussions and negotiations underway Neurogenic Program agreement expected Worldwide rights, with Japanese market e xception - exclusive agency licensing agreement with Tokyo - based Summit Pharmaceuticals International Corp., a wholly owned subsidiary of Sumitomo Corporation Group, to license NSI - 189 with a Japanese pharma for Japanese market Additional NSI - 189 straight - to - Phase II potential applications where hippocampal atrophy is indicated: Alzheimer's Disease - est. 5.4 million U.S. (AA/Alzheimer's Assn ) Cognitive complication due to Diabetes - est. 25.8 million type 1 and type 2 diabetes patients (ADA ) Stroke - est. 7 million stroke survivors U.S. (NSA) Traumatic Brain Injury - est. 1.7 million annually U.S. (CDC) Post - Traumatic Stress Disorder - 7.7 million U.S. (NIH) CTE - Chronic Traumatic Encephalopathy - unknown, data surfacing now; results from repeated TBI, est. 1.7 million single TBI cases annually U.S. (CDC) Neurodegeneration - numerous forms Anti - Aging ( Nootropic ) 21
Neuralstem - Strengths and Future Value Drivers 22 Scientific Strength, Out In Front Leader in neural stem cell science Repeated firsts in both divisions, including FDA approval: ALS and SCI neural stem cell trials & MDD lead novel neurogenic compound Technology platform R&D developed at NIH Broad, sustainable, worldwide IP protection NSI - 566: 2013 Year of Clinical Trial Advancements FDA IND clearance for cSCI Phase I received 1Q13 Stroke Phase I/II expected to commence in China in 1Q13 IND clearance for Acute SCI Phase I trial in S. Korea expected 1Q13 ALS Phase I/II in Mexico expected 1Q13 Expect to initiate ALS Phase II, with NIH and ALSA funding in 2Q13 NSI - 189: Breakthrough Year, Novel Neurogenics Topline data expected from 28 - day Phase Ib MDD trial in 2Q13 Partnership or License deal expected 2013 Multiple Phase II trial - ready hippocampus - atrophy applications
Appendix Management Patents: Technology and Products Proprietary Surgical Devices: Cell Therapy Published Papers World - Class Clinical Partners 23
Management: Dedicated, Driven Team Karl Johe , Ph.D., Chairman of the Board and Chief Scientific Officer Discovered and developed human neural stem cell technology, while at NIH Successful neural stem cell therapy is career - long goal Early work for four years as staff scientist at the NIH Laboratory of Molecular Biology of the National Institute of Neurological Disorders and Stroke in Bethesda (1993 - 1997) Education: Post Doctoral, Molecular Genetics, University of California San Francisco; Ph.D., Biochemistry, Albert Einstein College of Medicine: Masters and B.A., Chemistry, University of Kansas Richard Garr, JD , President and CEO Teamed legal and business expertise with friend Karl Johe's science background to co - found Neuralstem (1996) Focus on the business of science for 17 years; corporate legal, regulatory and patent experience Previous corporate and commercial law practice: Beli , Weil & Jacobs, the B&G Companies, and Circle Management Companies Education: J.D., Columbus School of Law, The Catholic University of America; B.A., Psychology, Drew University Co - founder and Director, First Star Foundation; Mid - Atlantic Chapter Co - founder, The Starlight Foundation; Former Honorary Chairman, Brain Tumor Society Thomas G. Hazel, Ph.D., Senior Vice President Served as Neuralstem's Stem Cell Discovery Program Director, 2000 - 2004; Senior Scientist, 1998 - 2000 Staff Scientist at the NIH Laboratory of Molecular Biology of the National Institute of Neurological Disorders and Stroke in Bethesda (1996 - 1998); IRTA fellow (1993 - 1996) Education: Ph.D., Genetics, University of Illinois College of Medicine; B.A., Biology, Kalamazoo College 24
Technology & Product U.S . Patents Issued and Reaffirmed Worldwide U. S. Pat. No. 8,236,299 (August 2012) Transplantation of human neural cells for treatment of neurodegenerative conditions U.S. Pat. No. 8,058,434 (November 2011) Compositions to effect neuronal growth U.S. Pat. No. 8,030,492 (October 2011) Compositions to effect neuronal growth U.S. Pat. No. 7,691,629 (April 2010) Transplantation of human neural cells for treatment of neurodegenerative conditions U.S. Pat. Nos. 7,560,553 and 7,858,628 (July 2009, December 2010) Use of fused nicotinamides to promote neurogenesis (div) U.S. Pat. No. 7,544,511 (June 2009) Stable neural stem cell line methods U.S. Pat. No. 6,284,539 (September 2001) Method for generating dopaminergic cells derived from neural precursors U.S. Pat. No. 6,040,180 (March 2000) In vitro generation of differentiated neurons from cultures of mammalian multipotential CNS stem cells U.S. Pat. No. 5,753,506 (May 1998) Isolation propagation and directed differentiation of stem cells from embryonic and adult central nervous system of mammals (div) 2 2 Patents Pending Neuralstem.com Live Map Includes Worldwide I.P . 25
Exclusive Worldwide Licenses: Breakthrough Cell Therapy Surgical Devices Spinal Platform and Floating Cannula Proprietary breakthrough medical devices proven safe in 18 surgeries New standard in industry and research community for intraspinal procedures Designed by ALS trial neurosurgeon, Nicholas M. Boulis , M.D., specifically for the world's first delivery of cells directly into the gray matter of the spinal cord Safety of device first reported in data presented at the American Association of Neurologists' 2011 Annual Meeting Patent - protected: U.S. Patent No. 8,092,495 (January 2012) Spinal Platform and Method for Delivering a Therapeutic Agent to a Spinal Cord Target Issued & Pending Patents: U.S. Patent No. 7,833,217 (November 2010 ) ; U.S . Application No. 12/913,527 Floating Spinal Cannula and Method of Use 26
Published Papers Long - Distance Growth and Connectivity of Neural Stem Cells after Severe Spinal Cord Injury. Paul Lu, Yaozhi Wang, Lori Graham, Karla McHale, Mingyong Gao , Di Wu, John Brock, Armin Blesch , Ephron S. Rosenzweig , Leif A. Havton , Binhai Zheng , James M. Conner, Martin Marsala , Mark H. Tuszynski Cell , Volume 150, Issue 6, 14 September 2012, Pages 1264 - 1273 Lumbar Intraspinal Injection of Neural Stem Cells in Patients with ALS: Results of a Phase I Trial in 12 Patients. Glass JD, Boulis NM, Johe K, Rutkove SB, Federici T, Polak M, Kelly C, Feldman, EL, Department of Neurology, Emory University School of Medicine, Atlanta Stem Cells , 2012 Jun;30(6):1144 - 51. Human neural stem cell grafts in the spinal cord of SOD1 transgenic rats: differentiation and structural integration into the segmental motor circuitry. Xu L, Ryugo DK, Pongstaporn T, Johe K, Koliatsos VE , Department of Pathology, Division of Neuropathology, The Johns Hopkins Medical Institutions, Baltimore The Journal of Comparative Neurology , 2009 Jun 1;514(4):297 - 309. Extensive neuronal differentiation of human neural stem cell grafts in adult rat spinal cord. Yan J, Xu L, Welsh AM, Hatfield G, Hazel T, Johe K, Koliatsos VE , Department of Pathology, Division of Neuropathology, The Johns Hopkins Medical Institutions, Baltimore PLoS Medicine , 2007 Feb;4(2):e39. Functional recovery in rats with ischemic paraplegia after spinal grafting of human spinal stem cells. Cizkova D, Kakinohana O, Kucharova K, Marsala S, Johe K, Hazel T, Hefferan MP, Marsala M , Institute of Neurobiology, Centrum of Excellence, Slovak Academy of Science, Kosice, Soltesovej 4, Slovakia. Neuroscience , 2007 Jun 29;147(2):546 - 60. Epub 2007 May 23. Combined immunosuppressive agents or CD4 antibodies prolong survival of human neural stem cell grafts and improve disease outcomes in amyotrophic lateral sclerosis transgenic mice. Yan J, Xu L, Welsh AM, Chen D, Hazel T, Johe K, Koliatsos VE, Department of Pathology, Neuropathology Division, The Johns Hopkins University School of Medicine, Baltimore Stem cells (Dayton, Ohio) , 2006 Aug;24(8):1976 - 85. Epub 2006 Apr 27. 27
World - Class Clinical P artners NSI - 566/ALS Trial Clinical Investigators: Principal Investigator: Eva L. Feldman, M.D., Ph.D., Professor of Neurology & Director A. Alfred Taubman Medical Research Inst. of the University of Michigan Medical School; President of American Neurological Assn. Site Principal Investigator: Jonathan D. Glass, M.D., Professor of Neurology & Director Emory ALS Center, Emory University Co - Investigator & Neurosurgeon: Nicholas M. Boulis M.D., Assist. Professor Neurosurgery, Emory University NSI - 566/ALS Trial Advisory Board: Zachary Simmons M.D., Chairman, SMB , Professor of Neurology Penn State University Hershey Medical Center and Director Neuromuscular Program and ALS Center Mark Bromberg M.D., Ph.D. Professor of Neurology & Director of the Motor Neuron Disease/ALS Clinic University of Utah School of Medicine Lucie Bruijn , Ph.D., Chief Scientist & Sr. VP of Research and Development ALS Association Thomas Freeman M.D., Professor, Dept of Neurosurgery & Medical Director, Center for Aging and Brain Repair University of South Florida College of Medicine Clifton L. Gooch, M.D., Professor & Chairman Department of Neurology & Director Division of Neuromuscular Disease University of South Florida College of Medicine Hiroshi Mitsumoto M.D., D.Sc., Professor of Neurology Columbia University & Director of the Eleanor and Lou Gehrig MDA/ALS Research Center and Neuromuscular Division at the Neurological Institute of New York Paul Park M.D., Assistant Professor & Neurosurgeon University of Michigan School of Medicine Mike Vogelbaum M.D., Ph.D. , Associate Director, Brain Tumor and Neuro - Oncology Center Cleveland Clinic NSI - 566/ Glioblastoma (Brain Cancer) Principal Investigator John Zhang, M.D., Ph.D., Professor of Neurosurgery, Loma Linda University, CA NSI - 566/Spinal Cord Injury Lead Collaborator Martin Marsala , M.D., Ph.D., University of California San Diego NSI - 189/Psychiatric/Small Molecule Trial Consultant Maurizio Fava, M.D., Slater Family Professor of Psychiatry at Harvard Medical School and Executive Vice Chair of the Department of Psychiatry at Massachusetts General Hospital 28
World Leader in Neural Stem Cell Science neuralstem.com