Category Archives: Stem Cell Human Trials

MissionIR would like to highlight Neuralstem, Inc. (NYSE AMEX: CUR). The company'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. In addition to ALS, Neuralstem is also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic spastic paraplegia, chronic stroke, and Huntington's disease. In the company's news yesterday, Neuralstem reported dosing of the fourteenth patient in its ongoing Phase I clinical trialing of the companys spinal cord neural stem cells in ALS (amyotrophic lateral sclerosis or Lou Gehrigs disease), marking the second patient to receive cells in the cervical (upper back) region of the spine and the trials first female patient. This is the first FDA-approved neural stem cell trial for the treatment of ALS. This treatment is designed to help remediate breathing function loss associated with progressive ALS, and the transplantation of stem cells observed in the trial will be keenly watched for safety/efficacy of spinal cord neural stem cells, as well as the intraspinal transplantation method. The first twelve patients … Continue reading →

MADISON, Wis., March 8, 2012 /PRNewswire/ --Cellular Dynamics International, Inc. (CDI), the world's largest commercial producer of human induced pluripotent stem (iPS) cell lines and tissue cells for drug discovery and safety, today announced several customer presentations of studies employing the company's iCell products at the Society of Toxicology (SOT) Annual Meeting on March 11 to 15 in San Francisco. A number of these studies demonstrate the superior predictivity of CDI's human iPS cell-derived products compared to other cell models, such as animal models and immortalized cell lines, which are historically used in pharmaceutical drug discovery and toxicity testing. Customers will present 11 abstracts employing CDI's human cells in their research during the SOT meeting. Several of these compare the superior ability of CDI's iCell Cardiomyocytes and iCell Hepatocytes to predict toxic responses to currently available cell models. Among them: Puppala, D et al. (Abstract 420 Poster Board -642; Pfizer, Inc.) compared the ability of iCell Cardiomyocytes to a rat cardiac-derived cell line (H9C2) to predict the toxicity of 10 known in vivo cardiac toxins that were not flagged by the company's current in vitro assay systems. They found that iCell Cardiomyocytes showed increases in several toxicity signals and were … Continue reading →

Summary of 2011 Highlights MENLO PARK, Calif., March 7, 2012 - Geron Corporation (Nasdaq: GERN - News) today reported financial results for the fourth quarter and year ended December 31, 2011. Fourth Quarter 2011 Results Net loss for the fourth quarter of 2011 was $31.9 million, or $0.25 per share, compared to $59.4 million, or $0.59 per share, for the comparable 2010 period. Net loss for the fourth quarter of 2011 included restructuring charges of $5.4 million related to discontinuation of the company`s stem cell programs and non-cash debt extinguishment charges of $1.7 million resulting from the repayment of the loan to the California Institute for Regenerative Medicine. Net loss for the fourth quarter of 2010 included a charge of $35.0 million in connection with an in-licensing transaction with Angiochem, Inc. The company ended the year with $154.2 million in cash and investments. In the fourth quarter of 2011, the company had revenues of $251,000, compared to $1.1 million for the comparable 2010 period. Revenues in both periods primarily reflected license fees and royalties. Revenues for the fourth quarter of 2010 also included funding under a collaborative agreement. Interest and other income for the fourth quarter of 2011 was $204,000, … Continue reading →

SAN DIEGO, CA--(Marketwire -03/07/12)- Medistem Inc. (Pinksheets: MEDS.PK - News) and Yale University have signed an exclusive worldwide licensing agreement covering the generation of pancreatic islets from stem cells such as the Endometrial Regenerative Cell (ERC). These pancreatic islets have effectively treated diabetes in animal models. Professor Hugh Taylor of Yale University, inventor of the technology, made international headlines in September 2011 when he published his findings in the peer-reviewed journal Molecular Therapy. "Medistem is the first company to develop clinical-grade endometrial-derived stem cells and initiate trials in humans," said Professor Taylor. "Since Medistem's Endometrial Regenerative Cells are manufactured inexpensively, can be used as an 'off the shelf' product, and to date appear safe in human subjects, I am very excited to see diabetes added to the list of diseases that can potentially be treated with Medistem's ERCs." Medistem is currently in two clinical trials with ERCs: One for critical limb ischemia and a second for congestive heart failure, both of which are complications of uncontrolled diabetes. "Type 1 diabetes is a rapidly growing poorly-served market. There is great optimism that cell-based therapies can address not only pancreatic degeneration but also the underlying immunological causes," said Dr. Alan Lewis, former … Continue reading →

SAN DIEGO, CA and PORTLAND, OR--(Marketwire -03/05/12)- Medistem Inc. (Pinksheets: MEDS.PK - News), in partnership with its Russian licensee, ERCell, announced the signing of a letter of intent* to begin clinical trials using Medistem's Endometrial Regenerative Cells (ERC) stem cells for renal, lung and peripheral artery disease. Trials will be conducted in the S.M. Kirov Military Medical Academy in St. Petersburg, Russia. Under the agreement, Medistem, ERCell and the Academy will work together to a) Design and obtain approval for clinical trials; b) Provide training and execute the trials; and c) Identify opportunities for commercialization of the ERC product through existing military and governmental programs. Under the license agreement, Medistem receives cash and royalty revenues from Russian developmental activities as well as all the data gathered from the trials. According to the agreement, work performed by ERCell will be conducted according to international "Good Clinical Practices" (GCP) so the data gathered can be used for Russian registration as well as to support US FDA submissions. "At Medistem, our philosophy has always been to follow the data. We aim to be as aggressive as possible, to obtain as much data as possible, as quickly as possible," stated Thomas Ichim, CEO of … Continue reading →

NEW YORK, NY--(Marketwire -03/05/12)- February was a challenging month for stem cell stocks. TickerSpy's Stem Cell Stocks Index (RXSTM) has slipped nearly 13 percent over the last month -- underperforming the S&P 500 by close to 17 percent over that time frame. Despite the drop in investor optimism, new research continues to propel the industry forward. Five Star Equities examines the outlook for companies in the Biotechnology industry and provides equity research on Advanced Cell Technology, Inc. (OTC.BB: ACTC.OB - News) and NeoStem, Inc. (AMEX: NBS - News). Access to the full company reports can be found at: http://www.fivestarequities.com/ACTC http://www.fivestarequities.com/NBS A new study at Johns Hopkins University has shown that stem cells from patients' own cardiac tissue can be used to heal scarred tissue after a heart attack. "This has never been accomplished before, despite a decade of cell therapy trials for patients with heart attacks. Now we have done it," Eduardo Marban, director of the Cedars-Sinai Heart Institute and one of the study's co-authors, said in a statement. "The effects are substantial." In another study, researchers led by Jonathan Tilly, director of the Vincent Center for Reproductive Biology at Massachusetts General Hospital, argue they've discovered the ovaries of young … Continue reading →

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT, OTCBB: ACTC), a leader in the field of regenerative medicine, today announced year-end results for the year ended December 31, 2011. The Company utilized $13.6 million in cash for operations during the year, compared to $8.8 million in the year-earlier period. The increase in cash utilization resulted primarily from ACTs ongoing clinical activities in the US and Europe. ACT ended the year with cash and cash equivalents of $13.1 million, compared to $15.9 million in cash and cash equivalents in the year-earlier period. Some of the 2011 highlights included: 2011 was a very important and successful year for ACT as we began our Phase 1/2 trials for the treatment of macular degeneration, said Gary Rabin, chairman and CEO of ACT. We are very excited about the preliminary Phase 1/2 clinical data from our dry-AMD and Stargardts disease trials, which were published in The Lancet earlier this year. The data demonstrated the safety of ACTs human embryonic stem cell (hESC)-derived retinal pigment epithelium (RPE) cells for the treatment of both diseases. The vision of both patients appears to have improved after transplantation, and no adverse safety issues have been observed. We look forward … Continue reading →

LONDON (Reuters) - Britain's Nuffield Council on Bioethics, which examines ethical issues raised by new developments in biology and medicine, launched a consultation on Thursday on the ethics of new technologies and devices that intervene in the human brain. The three main areas of the group's focus are brain-computer interfaces, neurostimulation and neural stem cell therapy. Here are some details about each area of research and how it is being explored. * Brain computer interfaces (BCIs) BCIs measure and analyse a person's brain signals and convert them into an output such as movement. A paralysed person, for example, could use a BCI to operate a wheelchair, or someone who has extreme difficulty speaking could use a BCI to communicate via a computer voice. These sorts of applications have been shown to be successful in a few reported cases, but the technology has not yet been developed for regular clinical use and there are questions over whether these technologies are reliable enough for use in everyday life. Military applications, such as remote control of vehicles and machinery are not yet in wide use but are being researched and tested, mainly in the United States. Some commercial BCI developments are already on … Continue reading →

MOUNTAINSIDE, NJ--(Marketwire -02/28/12)- PROTEONOMIX, INC. (OTC.BB: PROT.OB - News), a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, announced today progress regarding human trials on its product, UMK-121. Proteonomix has been informed that patient screening has commenced at the University of Miami. Proteonomix, CTO, Steven Byle stated that "We are excited to see our years of hard work and research investment coming to fruition. We at Proteonomix consider ourselves fortunate to be involved in a business that has the opportunity to try and help people in such dire need. We look forward to monitoring the trials going forward." It should be noted that effective March 7, 2012, a new FDA rule will require that informed consent documents state that the clinical trial has been or will be registered and the results will be published in the National Institutes of Health/National Library of Medicine clinical trials database (www.clinicaltrials.gov). After such date, it is anticipated that any person may find out additional information and follow the progress of these human trials on this government informational site. About Proteonomix, Inc.: Proteonomix is a biotechnology company focused on developing therapeutics based upon the use of human … Continue reading →

There is a tremendous opportunity in genetic medicine for innovation and for new players to make significant contributions, because it is still experimental, noted biologist and Nobel Laureate Dr David Baltimore said yesterday. “Today, it is mainly the province of biotechnology companies and universities, not big pharmaceutical companies,” he observed in a keynote presentation at the Qatar International Conference on Stem Cell Science and Policy 2012. There are new genetic tools available – though they are still experimental - to treat diseases which involve adding, subtracting or modifying genes in the cells of the body. “However, they are powerful tools and I am confident they will be an important part of the medicine of the future,” he said. Speaking on ‘The hematopoietic stem cell (HSC) as a target for therapy against cancer and Aids,’ Dr Baltimore explained that HSCs are one of the few cell types routinely used for bone marrow transplant. The HSCs are easily accessible, retroviruses can be used to carry genes into these stem cells, the genes are then expressed in all of cells that derive from the HSC and can correct inherited defects and bring genes that perform therapy under a programme called engineering immunity. “Though … Continue reading →