Category Archives: Stem Cell Human Trials

Because life is precious and human dignity needs to be respected, of course now anti-choice groups are now coming down on the Ice Bucket Challenge. There are plenty of legitimate reasons to question the unlikely philanthropic viral sensation of the summer from its gimmicky premise to the way it overshadows our own governments slashing of medical research funding but its hard to argue with the more than $13 million raised for ALS so far, or the awareness the stunt has raised for the vicious and so far incurable degenerative disease. But the story has taken a new twist as religious groups are now beginning to discourage followers from participating because ALS research at times relies on embryonic stem cells. This week, the Archdiocese of Cincinnati specifically asked Catholic school leaders at 113 schools to immediately cease any fundraising plans connected to the challenge, because the ALS Association funds at least one study using embryonic stem cells in direct conflict with Catholic teaching. Speaking to Religion News Service Tuesday, ALS Association representative Carrie Munk said, Currently, The Association is funding one study using embryonic stem cells (ESC), and the stem cell line was established many years ago under ethical guidelines set … Continue reading →

Because the ALS Association supports stem-cell research. The Ice Bucket Challenge has been the biggest viral-charity sensation of the year, and maybe ever reaching its cold, wet arms all the way to George W. Bush and Anna Wintour, and raising millions of dollars for ALS research along with providing an immaculate blooper reel. But one group is not pleased by all your Facebook videos: anti-abortion activists, who are mad that the ALS Association gives money to a group that supports stem-cell research. "Attention pro-lifers: be careful where you send your ALS Ice Bucket Challenge donation," blared a headline on LifeNews.com earlier this week. The article explained that the ALS Association, one of the charities receiving ice-bucket donations, gave $500,000 last year to the Northeast ALS Consortium, which in turn had been affiliated with a clinical trial that used "stem cells ... engineered from the spinal cord of a single fetus electively aborted after eight weeks of gestation. The tissue was obtained with the mothers consent." "Of course the fetus, from whom the 'tissue' was taken, did not 'give consent,'" LifeNews.com wrote. "So if you give to the ALS Association your money may end up supporting clinical trials that use aborted … Continue reading →

Human embryonic stem cells were differentiated into cells of the pancreas (blue). These cells give rise to insulin-producing cells (red). When implanted into mice, the stem cell-derived pancreatic cells effectively replace the insulin lost in type 1 diabetes. San Diego-based ViaCyte is developing an implantable artificial pancreas derived from human embryonic stem cells. Its work is funded in part by grants from the California Institute for Regenerative Medicine. San Diego's ViaCyte has received $20 million from a drug company to advance its stem cell-based therapy for type 1 diabetes into clinical trials. ViaCyte's agreement with Janssen Pharmaceuticals, a Johnson & Johnson company, comes days after the company announced receiving the go-ahead from the U.S. Food and Drug Administration to begin clinical trials. The agreement also includes the company's investment fund, Johnson & Johnson Development Corporation. ViaCyte's experimental product, VC-01, is derived from human embryonic stem cells. These cells are matured into cells that regulate blood sugar levels. These includes cells that make insulin, which lowers blood sugar, in addition to cells that make glucagon, which raises blood sugar levels. It's believed that recreating this natural complement of hormones will be more effective than administering insulin alone. The cells are encapsulated … Continue reading →

Paul Laikind, CEO of ViaCyte, which is making a treatment for diabetes from human embryonic stem cells. San Diego-based ViaCyte has received FDA permission to try its stem cell-based diabetes therapy. The Phase 1/2 combination trial will look for both safety and early signs of efficacy. ViaCyte grows replacement insulin-producing cells from human embryonic stem cells, which are placed in a semipermeable pouch. The pouch will be implanted into patients, allowing insulin and other hormones to enter the patient's bloodstream. The combination product of pouch and cells is called VC-01. ViaCyte says the product has the potential to provide a "virtual cure" for Type 1 diabetes. The company announced last month it had applied to begin the clinical trial. Animal trials have shown that the replacement cells successfully duplicate the function of the insulin-producing beta cells. These cells secrete not only insulin, which lowers blood sugar, but hormones such as glucagon, which raises it. Providing a range of hormones as in the natural pancreas is expected to provide better control of blood sugar than with insulin alone. The green light is not only good news for privately held ViaCyte, but for California's stem cell agency, the California Institute for Regenerative … Continue reading →

By Amy Norton HealthDay Reporter THURSDAY, Aug. 7, 2014 (HealthDay News) -- In a step toward using stem cells to treat paralysis, scientists were able to use cells from an elderly man's skin to regrow nerve connections in rats with damaged spinal cords. Reporting in the Aug. 7 online issue of Neuron, researchers say the human stem cells triggered the growth of numerous axons -- the fibers that extend from the body of a neuron (nerve cell) to send electrical impulses to other cells. Some axons even reached the animals' brains, according to the team led by Dr. Mark Tuszynski, a professor of neurosciences at the University of California, San Diego. "This degree of growth in axons has not been appreciated before," Tuszynski said. But he cautioned that there is still much to be learned about how the new nerve fibers behave in laboratory animals. Tuszynski likened the potential for stem-cell-induced axon growth to nuclear fusion. If it's contained, you get energy; if it's not contained, you get an explosion. "Too much axon growth into the wrong places would be a bad thing," Tuszynski said. For years, researchers have studied the potential for stem cells to restore functioning nerve connections … Continue reading →

Contact Information Available for logged-in reporters only Newswise Building upon previous research, scientists at the University of California, San Diego School of Medicine and Veterans Affairs San Diego Healthcare System report that neurons derived from human induced pluripotent stem cells (iPSC) and grafted into rats after a spinal cord injury produced cells with tens of thousands of axons extending virtually the entire length of the animals central nervous system. Writing in the August 7 early online edition of Neuron, lead scientist Paul Lu, PhD, of the UC San Diego Department of Neurosciences and colleagues said the human iPSC-derived axons extended through the white matter of the injury sites, frequently penetrating adjacent gray matter to form synapses with rat neurons. Similarly, rat motor axons pierced the human iPSC grafts to form their own synapses. The iPSCs used were developed from a healthy 86-year-old human male. These findings indicate that intrinsic neuronal mechanisms readily overcome the barriers created by a spinal cord injury to extend many axons over very long distances, and that these capabilities persist even in neurons reprogrammed from very aged human cells, said senior author Mark Tuszynski, MD, PhD, professor of Neurosciences and director of the UC San Diego … Continue reading →

Posted Tuesday, August 5 9:25 PM Pictured: Dr. Sophie Deng Dr. Sophie Deng, a prominent clinician scientist at UCLAs Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research, has been awarded a Bridging Supplement Award of $699,983 from the California Institute of Regenerative Medicine (CIRM), the states stem-cell agency, recognizing her cutting-edge, innovative research. Deng, noted by CIRM as a leader in the field, is a corneal specialist and associate professor of ophthalmology at UCLA. She was one of only two California investigators to receive CIRM Bridging Fund grants. She was awarded a CIRM Early Translational II grant in 2010, totaling $1.6 million, for her project to regenerate functional human corneal epithelial progenitor cells to treat a blinding corneal disorder called limbal stem-cell deficiency (LSCD). The new Bridge grant acknowledges the success of her project to-date and will provide the basis for new investigational drug applications to the FDA that will combine biology and engineering tools to efficiently expand and regenerate patient-specific limbal stem cells for transplantation to treat blindness through the initiation of human clinical trials. This award recognizes the need to bring this stem cell treatment that is available in Europe to the U.S., and … Continue reading →

Brain cells that were grafted into the brains of mice have become fully functionally integrated after six months. The successful neuron transplant could pave the way for therapies to treat neurodegenerative diseases such as Parkinson's. A team of stem cell researchers at the Luxembourg Centre for Systems Biomedicine created the grafted neurons -- induced neuronal stem cells -- in a petri dish out of the host's reprogrammed skin cells. This technique dramatically improved the compatibility of the implanted cells. Six months after the brain cells were implanted into the hippocampus and cortex regions of the brain, the neurons were fully integrated with the original brain cells via newly formed synapses (the contact points between neurons). The induced neuronal stem cells had changed into different types of brain cells -- neurons, astrocytes and oligodendrocytes -- over time within the host brain. Functional integration with the existing network of cells is absolutely critical for long-term survival of the new brain tissue. The new brain cells exhibited normal activity in tests and the mice showed no adverse side effects. The plan for researchers is now to explore replacing the type of neurons that tend to die off in the brain of Parkinson's patients … Continue reading →

Contact Information Available for logged-in reporters only Newswise BOSTON July 24, 2014 Japanese biologist Shinya Yamanaka won a Nobel Prize in 2012 for discovering how to create induced pluripotent stem cells (iPSCs), cells derived from normal adult cells that have the ability to differentiate into almost any other kind of cells. Scientists at Joslin Diabetes Center now have created the first iPSCs that offer a human model of insulin resistance, a key driver of type 2 diabetes. This is one of the very first studies of human iPSC models for type 2 diabetes, and it points out the power of this technology to look at the nature of diabetes, which is complex and may be different in different individuals, says C. Ronald Kahn, MD, Joslins Chief Academic Officer and the Mary K. Iacocca Professor of Medicine at Harvard Medical School. Until now, scientists examining the causes and effects of insulin resistance have struggled with a general lack of human cell lines from tissues such as muscle, fat and liver that respond significantly to insulin, Kahn says. Studying insulin resistance as it progresses through pre-clinical stages of type 2 diabetes has been particularly challenging. There have been no good human cell … Continue reading →

ViaCyte, a privately held regenerative medicine company developing a cell replacement therapy for the treatment of diabetes, has filed an Investigational New Drug application with the United States Food and Drug Administration, seeking to start a Phase 1/2 clinical trial in patients with type 1 diabetes, it was reported on Friday. The trial will assess the safety and efficacy of ViaCyte's VC-01 product candidate, a stem cell-derived, encapsulated cell replacement therapy. The company has also submitted a Medical Device Master File to the United States Food and Drug Administration in support of the Encaptra drug delivery system, the device component of the VC-01 product candidate. The company's VC-01 product candidate includes pancreatic progenitor cells, called PEC-01 cells, which are derived from a proprietary human embryonic stem cell line. Paul Laikind, Ph.D., president and chief executive officer of ViaCyte, said, 'The filing of this IND represents the culmination of many years of research and development by a dedicated team focused on developing a cell replacement therapy for patients with type 1 diabetes and advancing our VC-01 product candidate to human clinical trials. The ViaCyte team has been assisted and supported by the California Institute for Regenerative Medicine (CIRM) a leading organisation … Continue reading →