Fourteenth Patient Dosed in Neuralstem ALS Stem Cell Trial

ROCKVILLE, Md., March 7, 2012 /PRNewswire/ -- Neuralstem, Inc. (NYSE Amex: CUR) announced that the second patient to receive stem cells in the cervical (upper back) region of the spine was dosed on February 29th in the ongoing Phase I trial of its spinal cord neural stem cells in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). Patient 14 is also the first woman to be treated in the trial. Stem cell transplantation into the cervical region of the spinal cord couldsupport breathing, a key function that is lost as ALS progresses. The first twelve patients in the trial received stem cell transplants in the lumbar (lower back) region of the spinal cord only.

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"This cohort of patients represents another first for our trial, as we transplant cells directly into the gray matter of the spinal cord in the cervical region," said Karl Johe, PhD, Neuralstem's Chairman and Chief Scientific Officer. "We are delighted that the surgeries are progressing in a region that could have a significant impact on the quality of life for ALS patients. With the safe transplantation of our 14th patient, we are well are on our way to demonstrating the safety of our novel procedure."

About the Trial The Phase I trial to assess the safety of Neuralstem's spinal cord neural stem cells and intraspinal transplantation method in ALS patients has been underway since January 2010. The trial is designed to enroll up to 18 patients. The first 12 patients were each transplanted in the lumbar (lower back) region of the spine, beginning with non-ambulatory and advancing to ambulatory cohorts. The trial has now progressed to the final six patients. Each is in the cervical (upper back) region of the spine. The entire 18-patient trial concludes six months after the final surgery.

About Neuralstem Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem is in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.

In addition to ALS, the company is also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic spastic paraplegia and chronic stroke. The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in chronic spinal cord injury.

Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate new neurons, possibly reversing the pathologies of some central nervous system conditions. The company has received approval from the FDA to conduct a Phase Ib safety trial evaluating NSI-189, its first small molecule compound, for the treatment of major depressive disorder (MDD). Additional indications could include schizophrenia, Alzheimer's disease and bipolar disorder.

For more information, please visit http://www.neuralstem.com and connect with us on Twitter and Facebook.

Cautionary Statement Regarding Forward Looking Information This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Neuralstem's technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem's periodic reports, including the annual report on Form 10-K for the year ended December 31, 2010 and the quarterly report on Form 10-Q for the period ended September 30, 2011.

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Fourteenth Patient Dosed in Neuralstem ALS Stem Cell Trial

Stem Cell-Seeded Cardiopatch Could Deliver Results for Damaged Hearts

Durham, NC (PRWEB) March 07, 2012

A new type of stem cell-seeded patch has shown promising results in promoting healing after a heart attack, according to a study released today in the journal STEM CELLS Translational Medicine.

Ischemic heart disease, caused by vessel blockage, is a leading cause of death in many western countries. Studies have shown the potential of stem cells in regenerating heart tissue damaged during an attack. But even as the list of candidate cells for cardiac regeneration has expanded, none has emerged as the obvious choice, possibly because several cell types are needed to regenerate both the hearts muscles and its vascular components.

Aside from the choice of the right cell source for tissue regeneration, the best way to deliver the stem cells is up for debate, too, as intravenous delivery and injections can be inefficient and possibly harmful. While embryonic stem cells have shown great promise for heart repairs due to their ability to differentiate into virtually any cell type, less than 10 percent of injected cells typically survive the engraftment and of that number generally only 2 percent actually colonize the heart.

In order for this type of treatment is to be clinically effective, researchers need to find ways to deliver large numbers of stem cells in a supportive environment that can help cells survive and differentiate.

In the current cardiopatch study, conducted by researchers from the Faculty of Medicine of the Geneva University in collaboration with colleagues at the Ecole Polytechnique Federale de Lausanne (EPFL), cardiac-committed mouse embryonic stem cell (mESC) were committed toward the cardiac fate using a protein growth factor called BMP2 and then embedded into a fibrin hydrogel that is both biocompatible and biodegradable. The cells were loaded with superparamagnetic iron oxide nanoparticles so they could be tracked using magnetic resonance imaging, which also enabled the researchers to more accurately assess regional and global heart function.

The patches were engrafted onto the hearts of laboratory rats that had induced heart attacks. Six weeks later, the hearts of the animals receiving the mESC-seeded patches showed significant improvement over those receiving patches loaded with iron oxide nanoparticles alone. The patches had degraded, the cells had colonized the infarcted tissue and new blood vessels were forming in the vicinity of the transplanted patch. Improvements reached beyond the part of the heart where the patch had been applied to manifest globally.

Marisa Jaconi, PhD, of the Geneva University Department of Pathology and Immunology, and Jeffrey Hubbell, PhD, professor of bioengineering at the EPFL, were leaders on the investigative team. Their findings could make a significant impact on how heart patients are treated in the future. Altogether our data provide evidence that stem-cell based cardiopatches represent a promising therapeutic strategy to achieve efficient cell implantation and improved global and regional cardiac function after myocardial infarction, said Jaconi.

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The full article, Embryonic stem cell-based cardiopatches improve cardiac function in infarcted rats, can be accessed at: http://www.stemcellstm.com/content/early/recent.

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Stem Cell-Seeded Cardiopatch Could Deliver Results for Damaged Hearts

Stem cell repair kit for glaucoma could mean a treatment for the most common cause of blindness

By Fiona Macrae

Last updated at 1:55 AM on 8th March 2012

Important breakthrough: One in ten glaucoma sufferers go blind, due to late diagnosis, drugs not working or the disease being particularly severe (file picture)

A treatment for one of the most common causes of blindness could soon be available.

British researchers have used stem cells to heal the damage caused by glaucoma.

The treatment has only been tested on rats, but scientists say it could be tested on humans by 2015 and in widespread use four years later.

At present one in ten glaucoma sufferers go blind, due to late diagnosis, drugs not working or the disease being particularly severe.

Researchers at University College London took healthy stem cells master cells capable of turning into other types of cell and widely seen as a repair kit for the body from human eyes.

They used a cocktail of chemicals to turn them into retinal ganglion cells those that die in glaucoma. They then injected these into the eyes of rats with glaucoma-like damage.

After just four weeks, the cells had connected with existing nerve cells, and the animals eyes worked 50 per cent better, the journal Stem Cells Translational Medicine reports.

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Stem cell repair kit for glaucoma could mean a treatment for the most common cause of blindness

Cryo-Cell's Affiliate, Saneron CCEL Therapeutics, Releases Pre-clinical Data Indicating That Cord Blood Stem Cells …

Repeated injections of human umbilical cord blood cells improved motor neuron survival, delayed disease progression and increased lifespan

Oldsmar, FL (PRWEB) March 06, 2012

Dr. Julie G. Allickson, PhD. Vice President of Laboratory Operations and R&D, stated This groundbreaking study demonstrates the amazing capacity of cord blood stem cells to potentially treat a devastating neurodegenerative disease through the secretion of trophic factors that resulted in neuroprotection in the ALS mouse model. The data certainly justifies additional pre-clinical investigations using umbilical cord blood stem cells. This source of cells has mainly been used in hematopoietic and immune diseases in more than 25,000 transplants to date.

Cryo- Cell is excited about the results of the research Saneron CCEL Therapeutics has completed and proud of the progress Saneron has made in the treatment for ALS. The investment community does not appreciate the value of Cryo-Cells holdings in Saneron and its world-class research initiatives, commented David Portnoy, Cryo-Cells Chairman and CEO.

Given the delay between the onset of symptoms and the actual diagnosis of ALS, the data obtained from this study was critically important to show that multiple low-doses of cord blood cells started after the symptomatic disease stage in the ALS mouse model could benefit disease outcomes, said co-author Nicole Kuzmin-Nichols, President and COO of Saneron CCEL Therapeutics, Inc. Our continuing studies are aimed at translating the preclinical data into future clinical studies.

About Cryo-Cell International, Inc.

Cryo-Cell International, Inc. was founded in 1989 and was the worlds first private cord blood bank to separate and store stem cells in 1992. Today, Cryo-Cell has over 240,000 clients worldwide from 87 countries. Cryo-Cells mission is to provide our clients with the premier stem cell cryopreservation service and to support the advancement of regenerative medicine.

Cryo-Cell operates in a state-of-the-art Good Manufacturing Practice and Good Tissue Practice (cGMP/cGTP)-compliant facility, is ISO 9001:2008 certified and accredited by the AABB. Cryo-Cell is a publicly traded company. OTC:QB Markets Group Symbol: CCEL. Expectant parents or healthcare professionals may call 1-800-STOR-CELL (1-800-786-7235) or visit http://www.cryo-cell.com.

About Saneron CCEL Therapeutics, Inc.

Saneron CCEL Therapeutics, Inc. is a biotechnology R&D company, focused on neurological and cardiac cell therapy for the early intervention and treatment of several devastating or deadly diseases, which lack adequate treatment options. Saneron, a University of South Florida spin-out company is located at the Tampa Bay Technology Incubator. An affiliate of Cryo-Cell International, Inc., Saneron is committed to providing readily available, noncontroversial stem cells for cellular therapies and has patented and patent-pending technology relating to our platform technology of umbilical cord blood and Sertoli cells.

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Cryo-Cell's Affiliate, Saneron CCEL Therapeutics, Releases Pre-clinical Data Indicating That Cord Blood Stem Cells ...

UNC Hospitals preps for triple-tandem stem cell transplant

CHAPEL HILL, N.C. --

A Carrboro man is getting the first triple-tandem stem cell transplant performed at UNC Hospitals to treat a testicular cancer recurrence.

David Alston was diagnosed with testicular cancer a year ago. He went through chemotherapy at UNC and thought he'd beat it, but doctors discovered the cancerhad come back during a routine blood test.

"I was devastated", said Alston. "I completely fell apart."

He found hope again when Dr. Paul Armstead at UNC Hospitalssuggested a treatment that involved stem cell transplants.

"It's good for someone young like David whose already tolerated all the chemotherapy we've given him," said Dr. Armstead. "We think this is his best chance of being cured of this disease."

Alston's stem cells were recovered in a process that Alston says is like giving blood.

"Once we give a high dose of chemotherapy we then take some of his frozen bone marrow stem cells and give those back to him," explained Dr. Armstead. "This allows his blood count to recover and that's transplant number one."

Alston's treatment is unique because he'll receive three transplants. It's a process that will keep him in the hospital for about nine weeks and take a major toll on his immune system.

"I'm nervous because I know there's going to be a point where I just feel terrible," said Alston.

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UNC Hospitals preps for triple-tandem stem cell transplant

Influencing stem cell fate

Public release date: 6-Mar-2012 [ | E-mail | Share ]

Contact: Megan Fellman fellman@northwestern.edu 847-491-3115 Northwestern University

Northwestern University scientists have developed a powerful analytical method that they have used to direct stem cell differentiation. Out of millions of possibilities, they rapidly identified the chemical and physical structures that can cue stem cells to become osteocytes, cells found in mature bone.

Researchers can use the method, called nanocombinatorics, to build enormous libraries of physical structures varying in size from a few nanometers to many micrometers for addressing problems within and outside biology.

Those in the fields of chemistry, materials engineering and nanotechnology could use this invaluable tool to assess which chemical and physical structures -- including size, shape and composition -- work best for a desired process or function.

Nanocombinatorics holds promise for screening catalysts for energy conversion, understanding properties conferred by nanostructures, identifying active molecules for drug discovery or even optimizing materials for tissue regeneration, among other applications.

Details of the method and proof of concept is published in the Proceedings of the National Academy of Sciences.

"With further development, researchers might be able to use this approach to prepare cells of any lineage on command," said Chad A. Mirkin, who led the work. "Insight into such a process is important for understanding cancer development and for developing novel cancer treatment methodologies."

Mirkin is the George B. Rathmann Professor of Chemistry in the Weinberg College of Arts and Sciences and professor of medicine, chemical and biological engineering, biomedical engineering and materials science and engineering. He also is the director of Northwestern's International Institute for Nanotechnology (IIN).

The new analytical method utilizes a technique invented at Northwestern called polymer pen lithography, where basically a rubber stamp having as many as 11 million sharp pyramids is mounted on a transparent glass backing and precisely controlled by an atomic force microscope to generate desired patterns on a surface. Each pyramid -- a polymeric pen -- is coated with molecules for a particular purpose.

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Influencing stem cell fate

Influencing stem cell fate: New screening method helps scientists identify key information rapidly

ScienceDaily (Mar. 6, 2012) Northwestern University scientists have developed a powerful analytical method that they have used to direct stem cell differentiation. Out of millions of possibilities, they rapidly identified the chemical and physical structures that can cue stem cells to become osteocytes, cells found in mature bone.

Researchers can use the method, called nanocombinatorics, to build enormous libraries of physical structures varying in size from a few nanometers to many micrometers for addressing problems within and outside biology.

Those in the fields of chemistry, materials engineering and nanotechnology could use this invaluable tool to assess which chemical and physical structures -- including size, shape and composition -- work best for a desired process or function.

Nanocombinatorics holds promise for screening catalysts for energy conversion, understanding properties conferred by nanostructures, identifying active molecules for drug discovery or even optimizing materials for tissue regeneration, among other applications.

Details of the method and proof of concept is published in the Proceedings of the National Academy of Sciences.

"With further development, researchers might be able to use this approach to prepare cells of any lineage on command," said Chad A. Mirkin, who led the work. "Insight into such a process is important for understanding cancer development and for developing novel cancer treatment methodologies."

Mirkin is the George B. Rathmann Professor of Chemistry in the Weinberg College of Arts and Sciences and professor of medicine, chemical and biological engineering, biomedical engineering and materials science and engineering. He also is the director of Northwestern's International Institute for Nanotechnology (IIN).

The new analytical method utilizes a technique invented at Northwestern called polymer pen lithography, where basically a rubber stamp having as many as 11 million sharp pyramids is mounted on a transparent glass backing and precisely controlled by an atomic force microscope to generate desired patterns on a surface. Each pyramid -- a polymeric pen -- is coated with molecules for a particular purpose.

In this work, the researchers used molecules that bind proteins found in the natural cell environment, such as fibronectin, which could then be attached onto a substrate in various patterns. (Fibronectin is a protein that mediates cell adhesion.) The team rapidly prepared millions of textured features over a large area, which they call a library. The library consisted of approximately 10,000 fibronectin patterns having as many as 25 million features ranging in size from a couple hundred nanometers to several micrometers.

To make these surfaces, they intentionally tilt the stamp and its array of pens as the stamp is brought down onto the substrate, each pen delivering a spot of molecules that could then bind fibronectin. The tilt results in different amounts of pressure on the polymeric pens, which dictates the feature size of each spot. Because the pressure varies across a broad range, so does the feature size.

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Influencing stem cell fate: New screening method helps scientists identify key information rapidly