Category Archives: Stem Cell Human Trials

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT) (ACTC), a leader in the field of regenerative medicine, announced today that the Data and Safety Monitoring Board (DSMB), an independent group of medical experts closely monitoring the companys three ongoing clinical trials, has authorized the company to move forward with enrollment and treatment of remaining two patients in the third cohort of each of the three clinical trials. The decision follows an interim review by the DSMB six weeks after the first patient was treated in the third cohort of each trial. ACT will proceed with screening and enrollment for the patients who, in keeping with trial protocol, will be injected with 150,000 retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). We are pleased that the first patients treated with the higher dose of RPE cells are doing well and the DSMB sees fit for enrollment to continue in all three clinical trials, commented Gary Rabin, chairman and CEO of ACT. Even with several patients failing laboratory evaluations late in the inclusion/exclusion review process, which is not atypical in clinical trials, we have four of the six patient surgeries for the third cohorts scheduled, with two remaining … Continue reading →

ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE MKT: BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, announced that Chief Executive Officer Michael D. West, PhD will present today at the Case Western Reserve University in the meeting The Business of Regenerative Medicine: From Stem Cells to the Market Place in Cleveland, Ohio. Dr. Wests presentation titled Embryomics: Commercial Opportunities in the Increasing Complex Biology of Pluripotency is scheduled for 11:00 a.m. EDT. Dr. West will describe new data relating the company's PureStem technology and cell lines potentially useful in the treatment of Alzheimer's disease and for Alzheimer's disease research and will soon be made available for sale to the research community. The presentation is available on BioTimes website at http://www.biotimeinc.com/scientific-presentations. A discussion of the results presented in todays meeting is also discussed by Dr. West in his weekly video update available for viewing at http://www.biotimeinc.com/video-series/. About BioTime, Inc. BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is enhanced through subsidiaries focused on specific fields of application. BioTime develops and markets research products in the fields of stem … Continue reading →

Gene therapy: not just for mice. Genetic traits, like a bulbous nose or balding, give some people reasons to moan about what they inherited from their parents. But more serious genetic flaws can cause debilitating disease. Now, Italian researchers have come up with a way of treating one such inherited disease and reversing another using a promising new method of gene therapy. The idea behind gene therapy is to replace a faulty gene with a shiny new version that works properly. Modified versions of viruses, which have been sculpted by millions of years of evolution, perfectly penetrate human cells. They act as courriers delivering DNA payloads to defective cells and ensure they are stably inherited. This deceptively simple idea, though, has been challenging to achieve in practice. The first commercial gene therapy product, Glybera, only received regulatory approval in 2012. Part of the reason for this is the difficulty of successfully clearing three hurdles at once: delivering replacement genetic information to the exact cells that need help, getting this information safely translated in high enough volumes to overcome the defects, and stopping the immune system from reacting to normal genes when it has grown used to only seeing mangled ones. … Continue reading →

SAN DIEGO ViaCyte, a developer of a diabetes treatment from human embryonic stem cells, has raised $10.6 million in a private equity financing. The money will go to ViaCytes therapy for type 1 diabetes, the privately held company said Wednesday. ViaCyte said the financing included its largest existing investors: Johnson & Johnson Development Corp., Sanderling Ventures and Asset Management Co. The cash infusion represents a matching investment to a $10.1 million grant from the California Institute for Regenerative Medicine, the states stem cell agency. ViaCytes product, called VC-01, contains cells derived from human embryonic stem cells. These cells mature into the insulin-producing pancreatic cells destroyed in type 1 diabetes. The cells are enclosed in a semipermeable screen that protects the cells from the immune system, allowing them to receive nutrients and secrete insulin. The device has been tested in animals, and ViaCyte is preparing to begin human clinical trials Assuming all goes well, ViaCyte could start by the first or second quarter of 2014, said Chief Executive Paul Laikind. Only a few companies in the United States have used embryonic stem cells in clinical trials. Most use other kinds derived from nonembryonic sources, such as umbilical cord blood. This is … Continue reading →

Kounteya Sinha, TNN Jul 5, 2013, 05.00AM IST LONDON: Japanese scientists have for the first time grown a functional human liver tissue from stem cells. The breakthrough opens up the possibility of growing human organs in the lab, thus paving way for ending critical shortage of donor organs. Though it could take a decade to actually grow organs on a large scale for transplants, the latest study by Japanese scientists using stem cells derived from skin and blood are being looked at as "proof of concept." Takanori Takebe and Hideki Taniguchi at Yokohama City University showed the generation of vascularized and functional human liver from human-induced pluripotent stem cells (hiPSCs) by transplantation of in-vitro grown liver buds (rudimentary liver). This study also demonstrates a proof-of-concept that organ bud transplantation can be an alternative approach for treating organ failure by generating a 3D and vascularized organ. Critical shortage of donor organs for treating end-stage organ failure highlights the urgent need for generating organs from pluripotent stem cells. Despite many reports describing functional "cell" differentiation, no studies so far have succeeded in generating a three-dimensional vascularized "organ" such as liver so far, according to the researchers. This study, published in the journal … Continue reading →

Transplanted "liver buds" self-organized to grow into functional organs, staving off death in mice with liver failure By Monya Baker and Nature magazine This stem cell approach may one day help patients waiting for liver transplants. Image: Flickr/Tareq Salahuddin Showcasing more than fifty of the most provocative, original, and significant online essays from 2011, The Best Science Writing Online 2012 will change the way... Read More Transplanting tiny 'liver buds' constructed from human stem cells restores liver function in mice, researchers have found. Although preliminary, the results offer a potential path towards developing treatments for the thousands of patients awaiting liver transplants every year. The liver buds, approximately 4 mm across, staved off death in mice with liver failure, the researchers report this week in Nature. The transplanted structures also took on a range of liver functions secreting liver-specific proteins and producing human-specific metabolites. But perhaps most notably, these buds quickly hooked up with nearby blood vessels and continued to grow after transplantation. The results are preliminary but promising, says Valerie Gouon-Evans, who studies liver development and regeneration at Mount Sinai Hospital in New York. This is a very novel thing, she says. Because the liver buds are supported by … Continue reading →

Scientists in Japan said they had grown human liver tissue from stem cells in a first that holds promise for alleviating the critical shortage of donor organs. Creating lab-grown tissue to replenish organs damaged by accident or disease is a Holy Grail for the pioneering field of research into the premature cells known as stem cells. Now Takanori Takebe of the Yokohama City University Graduate School of Medicine and a team reported Wednesday in the journal Nature that they grew tissue "resembling the (human) adult liver" in a lab mouse. They first created induced pluripotent stem (iPS) cells which they mixed with other cell types and coaxed into "liver buds" -- the precursor clusters that develop into a liver. The buds, each about five millimetres (0.2 inches) big, were then transplanted onto a mouse brain, where they were observed transforming into a "functional human liver" complete with blood vessels, the scientists wrote. "To our knowledge, this is the first report demonstrating the generation of a functional human organ from pluripotent stem cells," said the report. The technique has yet to be tested in humans, but serves as an important proof of concept, it added. Stem cells are infant cells that … Continue reading →

There is a shortage of livers available for transplant, meaning thousands die every year (Reuters) Japanese scientists have grown a fully functional human liver from stem cells for the first time. The researchers from Yokohama City University created the organ by transplanting 'liver buds' from human stem cells to restore liver function in mice. Published in the journal Nature, Takanori Takebe and Hideki Taniguchi showed how they stopped mice with liver failure from dying by transplanting the stem cell-grown structures into them. At present, there is a huge demand for human livers for transplants. In the US last year, almost 3,000 people died waiting for a liver while 5,800 transplants took place. Embryonic stem cells were discovered in 1981 but scientists have hitherto been unable to generate a human organ because of the complex interactions between cells and tissues as they develop. However, the Yokohama City scientists challenged this belief by focusing on the earliest stage of organ creation# - the interactions during 'organ bud' development. There are two main types of stem cells: those that are harvested from embryos, and reprogrammed induced pluripotent stem cells (iPSCs) which are taken from skin and blood. The researchers used the latter type … Continue reading →

Scientists have created a tiny liver from stem cells that helped mice with chronic liver failure regain function. Researchers in Japan transplanted 4-millimeter-wide "liver buds" made from human stem cells into a mice. The transplanted liver buds, which were placed in the cranium or abdomen, were able to work in conjunction with the mice's own organs and secrete human liver-specific proteins. They also created human metabolites, tiny molecules that are produced when the body metabolizes a substance. Co-author Takanori Takebe, a stem-cell biologist at Yokohama City University in Japan, said to Nature this was the first time people have made a solid organ using pluripotent stem cells, which are mature skin cells that are re-programmed to become an embryonic cell that can express any genetic characteristics. Play Video Play Video In this case, the liver buds were made from pluripotent stem cells that were told to express liver genes. Endothelial cells (which line blood vessels) taken from umbilical chord blood and mesenchymal stem cells (which make bone, cartilage and fat) were put into the mix as well. "We just simply mixed three cell types and found that they unexpectedly self-organize to form a three-dimensional liver bud -- this is a … Continue reading →

Functional miniature human livers have been created from induced pluripotent stem cells, say Japanese researchers in a study published today in the journal Nature. (Click link to read study). Called "liver buds", these mini-livers metabolized drugs in a human fashion, and performed most other functions of a liver, the researchers said. Moreover, the implanted livers prolonged survival of mice with chemically induced liver failure, as compared to control mice given a sham operation. The researchers used a new method to create the liver buds, grown on glass slides. They surrounded the nascent liver tissue with two other cell types that supported formation of the buds, including human umbilical vein endothelial cells. These cells self-organized and created their own blood vessels. When implanted, the liver buds hooked up to the mouse circulatory system. "Notably, although cells were plated in two-dimensional conditions, human iPSC-HEs (liver cells grown from IPS cells) self-organized into macroscopically visible three-dimensional cell clusters by an intrinsic organizing capacity up to 48 (hours) after seeding," the paper stated. Takanori Takebe, of Yokohama City University Graduate School of Medicine, is the paper's first author. The senior author is Hideki Taniguchi, also of the university. Other organs such as kidneys can … Continue reading →