StemCells ! Günstig wie nie ....

StemCells, Inc. Announces World's First Neural Stem Cell Transplant in Spinal Cord Injury Patient

22 Sep 2011

StemCells announced that the first patient in the Company's breakthrough Phase I/II clinical trial in chronic spinal cord injury was successfully transplanted with the Company's proprietary HuCNS-SC(R) adult neural stem cells

NEWARK, CA, USA | September 22, 2011 | StemCells, Inc. (Nasdaq: STEM) announced today that the first patient in the Company's breakthrough Phase I/II clinical trial in chronic spinal cord injury was successfully transplanted with the Company's proprietary HuCNS-SC(R) adult neural stem cells. The stem cells were administered yesterday at Balgrist University Hospital, University of Zurich, a world leading medical center for spinal cord injury and rehabilitation. The transplant surgery was performed by a team of surgeons led by Dr. Raphael Guzman, a visiting staff neurosurgeon also on faculty at Department of Neurosurgery, Stanford University, and Dr. K. Min, an orthopedic surgeon at Balgrist University Hospital.

"I am pleased to be a part of this innovative clinical trial designed to help us assess the safety and potential efficacy of HuCNS-SC stem cells for spinal cord injury," explains Dr. Armin Curt, Principal Investigator. "The preclinical data underlying this trial provided compelling rationale to conduct a study of this nature in spinal cord-injured patients." StemCells, Inc. has published numerous preclinical studies demonstrating the therapeutic potential of the Company's human neural stem cells for the treatment of acute and chronic spinal cord injury. These studies were conducted in close collaboration with Drs. Aileen Anderson and Brian Cummings of the University of California, Irvine.

The first patient transplanted in the trial, a 23-year-old German man, suffered a spinal cord injury in an automobile accident in April of this year. He sustained a complete loss of sensation and mobility from the waist down. When asked about his decision to enroll in this leading-edge study, he said: "This terrible injury crossed out almost all my life plans, and has led me to an unexpected path. Participating in this clinical trial not only gives me a sense of hope, but it also helps move this important research forward."

"With this first patient enrolled and dosed, we remain on track to meet our goal of treating the first cohort of patients by the end of this year," said Stephen Huhn MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc. "While the trial's first cohort will consist of patients with the most severe, complete injury, the second and third cohorts will progress to patients with less severe, incomplete injury. This unique trial design will allow us to evaluate the potential of our HuCNS-SC cells as a treatment for a broad spectrum of spinal cord injury patients. Even a small improvement could have a marked impact on quality of life for the millions of people who suffer from this debilitating condition."

About the Clinical Trial

The Phase I/II clinical trial of StemCells, Inc.'s HuCNS-SC purified human adult neural stem cells is designed to assess both safety and preliminary efficacy. Twelve patients with thoracic (chest-level) neurological injuries at the T2-T11 level are planned for enrollment. The first three patients will all have injuries classified as ASIA A, in which there is no apparent neurological function below the injury level, the most severe level identified by the American Spinal Injury Association (ASIA) Impairment Scale. The second and third cohorts will be patients classified as ASIA B and ASIA C, those with less severe injury, in which there is some preservation of sensory or motor function. In addition to assessing safety, the trial will assess preliminary efficacy based on defined clinical endpoints, such as changes in sensation, motor and bowel/bladder function.

All patients will receive HuCNS-SC cells through direct transplantation into the spinal cord and will be temporarily immunosuppressed. Patients will be evaluated regularly in 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 recovery of neurological function below the injury site. The Company intends to follow the effects of this therapy long-term, and a separate 4-year observational study will be initiated at the conclusion of this trial.

For information on patient enrollment, interested parties may contact the study nurse either by phone at +41 44 386 39 01, or by email at stemcells.pz@balgrist.ch.

Additional information about the Company's spinal cord injury program can be found on the StemCells, Inc. website at http://www.stemcellsinc.com/Therapeutic-Programs/Clinical-Trials.htm and at http://www.stemcellsinc.com/Therapeutic-Programs/...-Cord-Injury.htm, including video interviews with Company executives and independent collaborators.

About Chronic Spinal Cord Injury

According to a study reported by the Christopher and Dana Reeve Foundation, nearly 1.3 million people in the United States are estimated to be living with chronic spinal cord injury. The chronic phase of spinal cord injury is considered to begin when inflammation has stabilized and recovery has reached a plateau, which is typically several months following injury. Currently, there are no effective treatment options for patients with chronic spinal cord injury, and treatment approaches have generally targeted the acute and sub-acute time points, which are within hours or days of injury. Given the unmet need in chronic spinal cord injury, restoring some degree of function for patients at time points beyond the acute phase could have a transformative impact on the field. StemCells hopes to address a broad population of spinal cord-injured patients by opening the window of opportunity for therapeutic intervention well after the acute injury and targeting a wide range of injury levels and degrees of impairment.

MFG
Chali  

gab schon lange keine news mehr...  

schon mal nicht schlecht angesichts der letzten Umsätze.  

Dazu wird seit einigen Tagen an der 90 geknabbert,
noch ist es nicht so weit.
Nächste Woche wird die 90 geknackt, dann geht es fix weiter.
isr hat es heute vorgemacht, STEM macht es auch noch nach.  

 

wie schön,dass du meinen alten Thread mal wiederbelebt hast ! Hast du dir wirklich 100K zugelegt ? Gratulation !! Seit dem Geron raus ist aus der Geschichte,könnte STEM noch massig steigen,siehe heute ......

MFG
Chali  

BOSTON (MarketWatch) -- Shares of StemCells Inc. /quotes/zigman/5728491/quotes/nls/stem STEM +51.74% rocketed nearly 40% to $1.19 on Tuesday on news that a study of its neural stem-cell therapy restored memory and enhanced synaptic function in laboratory animals with Alzheimer's disease. The study noted that the improvements were seen without a reduction of two proteins associated with the disease, beta amyloid and tau, which have been the focus of most ongoing Alzheimer's research. The stem cells were transplanted in an area of the brain called the hippocampus, which is believed to control memory. "While reducing beta amyloid and tau burden is a major focus in AD research, our data is intriguing because we obtained improved memory without a reduction in either of these pathologies," said StemCells Stephen Huhn, in a statement. "AD is a complex and challenging disorder. The field would benefit from the pursuit of a diverse range of treatment approaches and our neural stem cells now appear to offer a unique and viable contribution in the battle against this devastating disease," Huhn added.

MFG
Chali  

8:31AM StemCells announces its human neural stem cells restore memory in models of Alzheimer's Disease (STEM) 0.87 : The study results showed that transplanting the cells into a specific region of the brain, the hippocampus, statistically increased memory in two different animal models. Importantly, these results did not require reduction in beta amyloid or tau that accumulate in the brains of patients with AD and account for the pathological hallmarks of the disease.

MFG
Chali  

hatte nur immer mal den Umsatz beobachtet,
und da war dieser 100 k Kauf schon herausragend
bei dem eingeschlafenen vol. (war aber nicht meiner, hallo 100 k?)
nun heute ist ja ordentlich vol drin.
Habe natürlich meine 10 K zu früh verkauft,
ich lerne es halt nicht, mal wenigstens ein paar freebies laufen zu lassen.
Aber ich hätte wetten können, dass die noch mal ein gap-close versuchen
und hatte mich knapp über nem Dollar wieder positioniert,
aber ne, sonst machen sie jedes gap-up zu,
heute natürlich nicht, is klar.




nun janettes  

die amis sind so geil, erst intressiert es keine sau und schicken das ding
auf 58 und nun übertreiben sie das teil nach oben
wegen einer pre-clinical-news.
Ich hab ja grundsätzlich nichts dagegen, aber das sie diesmal das gap-up nicht mal annähernd kurz
intraday versucht haben zu schließen, nehm ich ihnen schon übel, Idioten, grrr.
Was solls, bin ich selbst schuld, dass ich nicht paar hab weiter laufen lassen.
Viel Erfolg den Neu- und Altinvestierten.  

 

staender....ggg
aber das gap werdens wohl erst noch zu machen  

 

dollar  

aber bei den Amis weiß man nie! Oxigene ist auch mal tagelang gestiegen, um dann erst wieder nachzugehen! Erstmal an der Seitenlinie beobachten würde ich sagen, wer noch nicht investiert ist. Wer bereits drin ist, sollte seinen SL nachziehen. Aber natürlich alles meine persönliche Meinung und keine Kaufs- oder Verkaufsempfehlung.

 

Habs dem Chali heute morgen schon geschrieben:

Nachdem STEM gestern bei 1,78 USD(- 13,71 %) geschlossen hatte, war ich heute morgen auf ein Blutbad in meinem Depot gefasst.

Jedoch - nichts da! Das Bid stand sowohl in STU als auch in FRA festgemauert bei 1,68 bis 1,695 Euro.

Umrechnung 1,78 USD in Euro = 1,447!!! Schwein gehabt!

D.h. der gestrige Schlusskurs war in D überhaupt nicht eingepreist!

Hat jemand eine Erklärung dafür? Vorbörslich geht´s nun 25 % up.  

Ich habe gerade in usa gekauft. super news. super chart  

hoffe ihr seid noch dabei,es könnte sich langfristig lohnen ! Werde bald mit einer grösseren Posi einsteigen ....

MFG
Chali  

Ja ich bleibe dabei. Die story ist einfach super. Heute auch gute Nachrichten bei bio firma:ECYT  

NEWARK, Calif., Oct. 4, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced that the first patient in its Phase I/II clinical trial in dry age-related macular degeneration (AMD) has been enrolled and transplanted. The trial is designed to evaluate the safety and preliminary efficacy of the Company's proprietary HuCNS-SC(R) product candidate (purified human neural stem cells) as a treatment for dry AMD, and the patient was transplanted with the cells yesterday at the Retina Foundation of the Southwest (RFSW) in Dallas, Texas, one of the leading independent vision research centers in the United States. AMD afflicts approximately 30 million people worldwide and is the leading cause of vision loss and blindness in people over 55 years of age.

"This trial signifies an exciting extension of our on-going clinical research with neural stem cells from disorders of the brain and spinal cord to now include the eye," said Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc. "Studies in the relevant animal model demonstrate that the Company's neural stem cells preserve vision in animals that would otherwise go blind and support the therapeutic potential of the cells to halt retinal degeneration. Unlike others in the field, we are looking to intervene early in the course of the disease with the goal of preserving visual function before it is lost."

David G. Birch, Ph.D., Chief Scientific and Executive Officer of the RFSW and Director of the Rose-Silverthorne Retinal Degenerations Laboratory and principal investigator of the study, added, "We are excited to be working with StemCells on this ground breaking clinical trial. There currently are no effective treatments for dry AMD, which is the most common form of the disease, and there is a clear need to explore novel therapeutic approaches."

In February 2012, the Company published preclinical data that demonstrated HuCNS-SC cells protect host photoreceptors and preserve vision in the Royal College of Surgeons (RCS) rat, a well-established animal model of retinal disease which has been used extensively to evaluate potential cell therapies. Moreover, the number of cone photoreceptors, which are responsible for central vision, remained constant over an extended period, consistent with the sustained visual acuity and light sensitivity observed in the study. In humans, degeneration of the cone photoreceptors accounts for the unique pattern of vision loss in dry AMD. The data was published in the international peer-reviewed European Journal of Neuroscience.

About Age-Related Macular Degeneration

Age-related macular degeneration refers to a loss of photoreceptors (rods and cones) from the macula, the central part of the retina. AMD is a degenerative retinal disease that typically strikes adults in their 50s or early 60s, and progresses painlessly, gradually destroying central vision. According to the RFSW website, there are approximately 1.75 million Americans age 40 years and older with some form of age-related macular degeneration, and the disease continues to be the number one cause of irreversible vision loss among senior citizens in the United States with more than seven million at risk of developing AMD.

About the Trial

The Phase I/II trial will evaluate the safety and preliminary efficacy of HuCNS-SC cells as a treatment for dry AMD. The trial will be an open-label, dose-escalation study, and is expected to enroll a total of 16 patients. The HuCNS-SC cells will be administered by a single injection into the space beneath the retina in the most affected eye. Patients' vision will be evaluated using both conventional and advanced state-of-the-art methods of ophthalmological assessment. Evaluations will be performed at predetermined intervals over a one-year period to assess safety and signs of visual benefit. Patients will then be followed for an additional four years in a separate observational study. Patients interested in participating in the clinical trial should contact the site at (214) 363-3911.

About HuCNS-SC Cells

StemCells' proprietary product candidate, HuCNS-SC cells, is a highly purified composition of human neural stem cells that are expanded and stored as banks of cells. The Company's preclinical research has shown that HuCNS-SC cells can be directly transplanted in the central nervous system (CNS) with no sign of tumor formation or adverse effects. Because the transplanted HuCNS-SC cells have been shown to engraft and survive long-term, there is the possibility of a durable clinical effect following a single transplantation. StemCells believes that HuCNS-SC cells may have broad therapeutic application for many diseases and disorders of the CNS, and to date has demonstrated human safety data from completed and ongoing clinical studies.

About The Retina Foundation of the Southwest

The Retina Foundation of the Southwest is an independent, non-profit research organization located in Dallas, Texas. The Foundation has grown into one of the leading independent vision research centers in the United States, with a staff dedicated to finding the causes, treatments and potential cures for blinding eye diseases. Along the way, the Foundation has made a life changing difference in the lives of patients who suffer from retina related diseases. Patients are referred by ophthalmologists from around the world, and because the center is funded by philanthropic and federal grants, patient services are entirely free. The Foundation is a volunteer-driven organization dedicated to making a difference in people's lives by improving their vision -- no matter what their age or financial status. Scientists and clinicians at the Foundation use the power of modern technology to understand the intricacy of retinal function and conduct studies of hereditary and acquired blinding retinal disorders, including retinitis pigmentosa and age-related macular degeneration. Other studies address eye disorders affecting the sight of infants and children, including hereditary eye diseases, cataracts, prematurity and the consequences of eye muscle imbalance. Further information about the RFSW is available at http://www.retinafoundation.org.

About StemCells, Inc.

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's lead therapeutic product candidate, HuCNS-SC(R) cells (purified human neural stem cells), is currently in development as a potential treatment for a broad range of central nervous system disorders. In March 2012, the Company reported results from a Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children. The trial results showed preliminary evidence of progressive and durable donor-derived myelination in all four patients transplanted with HuCNS-SC cells. The Company is conducting a Phase I/II clinical trial in chronic spinal cord injury in Switzerland and recently reported positive interim safety data for the first patient cohort. The Company is also conducting a Phase I/II clinical trial in dry age-related macular degeneration (AMD). In addition, the Company is pursuing preclinical studies of its HuCNS-SC cells in Alzheimer's disease. StemCells also markets stem cell research products, including media and reagents, under the SC Proven(R) brand. Further information about StemCells is available at http://www.stemcellsinc.com.

The StemCells, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?

MFG
Chali  

.... wie es bei Sarepta seit einigen monaten abgeht ? Hintergrund sind gute Phase-2 Ergebnisse einer muskelschwund Krankheit. Das Ganze nur mal als Vorgeschmack,wie es in Zukunft bei Stemcells auch laufen könnte,denn wir sind seit Kurzem im dry and wet AMD Bereich .....  

One company that might not yet be on the philanthropist investor radar yet is StemCells Inc. (STEM).

StemCells engages in the research, development, and commercialization of stem cell therapeutics, and related tools and technologies for academia and industry. It develops cell-based therapeutics for the central nervous system and liver.

StemCells priority focus at this time is on age-related macular degeneration (AMD), a medical condition which usually affects older adults and results in a loss of vision in the center of the visual field (the macula) because of damage to the retina. It occurs in "dry" and "wet" forms. AMD afflicts approximately 30 million people worldwide and is the leading cause of vision loss and blindness in people over 55 years of age.

Macular degeneration can make it difficult or impossible to read or recognize faces, although enough peripheral vision remains to allow other activities of daily life.

Starting from the inside of the eye and going towards the back, the three main layers at the back of the eye are the retina, which contains the nerves; the choroid, which contains the blood supply; and the sclera, which is the white of the eye.

StemCells announced on October 4th that the first patient in its Phase I/II clinical trial in dry AMD has been enrolled and transplanted. The trial is designed to evaluate the safety and preliminary efficacy of the company's proprietary HuCNS-SC product candidate (purified human neural stem cells) as a treatment for dry AMD.

StemCell's premise is to use tissue-derived stem cells only in that same organ, i.e., a homologous approach. For example, to use CNS-derived neural stem cells for the treatment of CNS disorders and liver-derived cells for the treatment of liver disorders. These multi-potent, tissue-derived "adult" stem cells are naturally pre-programmed to become the mature functional cells of the organ in which they are found, so they are directly transplantable into the same type of organ. Conversely, embryonic stem (ES) and induced pluripotent stem (IPS) cells have the potential to differentiate into any of the various cell types of the body, and so they would need to be re-programmed or genetically modified in order to reduce the risk of transplanting unwanted cell types.

While StemCells is a cheaper stock selling for $2.04 a share with a market cap of $62.34M, philanthropist investors might be beginning to take notice of this one -- I think deeper due diligence might be in order for StemCells.

MFG
Chali  

www.ariva.de/forum/Like-buying-Apple-in-1997-buy-Organovo-today-470965

Chali

 

NEWARK, Calif., Oct. 10, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM) today announced that two papers reporting clinical and preclinical data demonstrating the therapeutic potential of the Company's proprietary HuCNS-SC(R) cells (purified human neural stem cells) for a range of myelination disorders were published in the Oct. 10 edition of Science Translational Medicine, the peer review journal of the American Association for the Advancement of Science (http://stm.sciencemag.org/).

The paper by Gupta, et al. describes the encouraging results of the Company's Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a genetic myelination disorder that afflicts children. In the trial, which was completed in February 2012, four patients were transplanted with the Company's HuCNS-SC cells and all showed preliminary evidence of progressive and durable donor cell-derived myelination. Three of the four patients showed modest gains in their neurological function, which suggests a departure from the natural history of the disease; the fourth patient remained stable. Although clinical benefit cannot be confirmed in a trial without control patients, the small but measureable gains in function at one year may represent signals of a clinical effect to be further investigated in a controlled trial with more patients.

The second of the two papers, by Uchida, et al., summarizes extensive preclinical research which demonstrated that transplantation of the Company's neural stem cells in an animal model of severe myelin deficiency results in new myelin which enhanced the conductivity of nerve impulses. Myelin is the substance that insulates nerve axons, and without sufficient myelination, nerve impulses are not properly transmitted and neurological function is impaired. This preclinical data provided the rationale for the PMD clinical trial and supports the Company's cell therapy approach to other myelination disorders, such as transverse myelitis, certain forms of cerebral palsy, and multiple sclerosis.

"For the first time, we have evidence that transplanted neural stem cells are able to produce new myelin in patients with a severe myelination disease," Nalin Gupta, MD, PhD, associate professor of neurological surgery and pediatrics and chief of pediatric neurological surgery at UCSF Benioff Children's Hospital, and co-principal investigator of the PMD clinical trial. "We also saw modest gains in neurological function, and while these can't necessarily be attributed to the intervention because this was an uncontrolled trial with a small number of patients, it is an important first step which provides hope that HuCNS-SC transplantation may be able to address the fundamental pathology in the brain of PMD patients."

Patients with PMD have a defective gene which leads to insufficient myelin in the brain, which leads to a progressive loss of neurological function and death. In the clinical trial, four patients with connatal PMD, the most severe form of the disease, were enrolled and transplanted with HuCNS-SC cells. The patients were followed for twelve months after transplantation, during which time they underwent intensive neurological assessments and magnetic resonance (MR) imaging at regular intervals. The findings from the trial indicate a favorable safety profile for the HuCNS-SC cells and the transplantation procedure. Analysis of the MR imaging data showed changes consistent with increased myelination in the region of the transplantation, and which progressed over time and persisted after the withdrawal of immunosuppression at nine months. The results support the conclusion of durable cell engraftment and donor-derived myelin in the transplanted patients' brains. The development of new myelin signals is unprecedented in patients with connatal PMD. In addition, clinical assessment revealed small but measureable gains in motor and/or cognitive function in three of the four patients; the fourth patient remained clinically stable. While clinical benefit cannot be confirmed without a controlled study, these clinical outcomes suggest the HuCNS-SC cells may be having a beneficial effect on the patients.

The second paper, whose lead author is Nobuko Uchida, Vice President of Stem Cell Biology at StemCells, Inc., describes research which shows that when HuCNS-SC cells were transplanted into the shiverer mouse, a common model of severe central nervous system (CNS) dysmyelination, the cells formed new, functional myelin in the mice. Sophisticated analytical techniques were used to confirm that changes measured by MR images were in fact derived from new human myelin generated by the transplanted HuCNS-SC cells. MR imaging is routinely used in the diagnosis and clinical characterization of demyelinating diseases such as multiple sclerosis, and these results supported the use of similar techniques to detect and evaluate the degree of myelination in the Phase I PMD trial. Moreover, the new myelin was shown to be functional as conductivity of nerve impulses in the mice was enhanced.

"Demonstration of functional myelin formation in animals showing disease symptoms is significant and opens up the potential to treat patients with a range of severe myelin disorders," said Stephen A. Back, MD, PhD, professor of pediatrics and neurology at Oregon Health & Science University Doernbecher Children's Hospital, and senior author of the preclinical paper.

Stephen Huhn, MD, FACS, FAAP, Vice President and Head of the CNS Program at StemCells, Inc., added, "Having these two papers published concurrently illustrates the direct pathway of how we are translating groundbreaking scientific research to the clinical setting. The data in these papers make a powerful statement about the potential of our HuCNS-SC cells to address not only PMD, but a wide spectrum of myelination disorders. We are actively moving forward with our plans to conduct a controlled Phase II clinical study in PMD and evaluating our next steps with respect to other myelination disorders."

Conference Call

StemCells, Inc. will host a live webcast, today, October 10, at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss the data reported in these papers. Interested parties are invited to view the webcast over the Internet via the link at http://www.stemcellsinc.com/News-Events/Events.htm. An archived version of the webcast will be available for replay on the Company's website approximately two hours following the conclusion of the live event and will be available for a period of 30 days.

MFG
Chali  

NEW YORK (AP) -- Shares of StemCells Inc. jumped Tuesday after the company said it finished treating the first group of patients in a clinical trial of its stem cell therapy.

THE SPARK: StemCells said it has completed treatment for three patients and is now observing their long-term health. All three had suffered a "complete" spinal cord injury at chest level, which means they had no nerve function or feeling below the area that was injured. The company said two of the patients had greater sensory function a year after treatment, and one had recovered to the point that the injury is now considered "incomplete."

StemCells said that as far as it knows, this is the first time a patient has experienced that kind of improvement after treatment with neural stem cells.

The study measured changes in the patients' sensitivity to touch, heat and electrical stimuli. StemCells said one of the patients didn't experience any improvement.

THE BIG PICTURE: The Newark, Calif., company is studying therapies based on purified adult neural stem cells. It had previously reported that two of the three patients had improved six months after they were treated. StemCells is also testing its treatment on patients with complete injuries, and said it hopes those patients will have similar or larger improvements because they still have some nerve function.

Stem cell therapies are still an experimental field, and StemCells is a small company without any approved products.

SHARE ACTION: StemCells shares climbed 38 cents, or 22.8 percent, to $2.02 in afternoon trading. The stock has doubled in value since-mid July, when the company reported positive preclinical data for an experimental Alzheimer's disease therapy.

MFG
Chali