MENLO PARK, Calif., August 18, 2009 – Geron Corporation announced that its IND (Investigational New Drug application) for GRNOPC1, a cell therapy for neurologically complete, subacute spinal cord injury, has been placed on clinical hold by the FDA pending the agency’s review of new nonclinical animal study data submitted by the company. A clinical hold is an order that the FDA issues to a sponsor to delay a proposed trial or to suspend an ongoing trial.
Since filing the IND, Geron has been undertaking studies to enable dose escalation of its spinal cord injury product, and has been investigating application
UC San Diego scientists have dramatically improved the success rate of genetically modifying human embryonic stem cells. This advance brings the promise of better treatment of genetic diseases.
The new approach works in 20 percent of embryonic stem cells, compared to less than 1 percent treated with standard methods, said Yang Xu, a UCSD professor of biology, who led the study, assisted by Hoseok Song and Sun-Ku Chung, postdoctoral fellows in his lab.
The study was published Thursday in the journal Cell Stem Cell.
Some genetic diseases can’t be studied adequately in animals, Xu said, so the ability to produce human cells
With veterinarians across the country training to use stem cells for tendon and ligament repair, a professor at the University of California, Davis (UC Davis) wants to take the technology a step further by applying them to chronic, cell-based diseases.
Richard Vulliet, DVM, is very early into the work. But he is optimistic about the evidence as it exists, of course, and he may have had a success.
Vulliet has treated four dogs with degenerative myelopathy with their own stem cells, which he prefers to call mesenchymal stem cells or pluripotent marrow stromal cells. The terminology has evolved and those names
In the first evidence of a natural intervention triggering stem cell-based regeneration of an organ or system, a study shows that cycles of prolonged fasting not only protect against immune system damage — a major side effect of chemotherapy — but also induce immune system regeneration, shifting stem cells from a dormant state to a state of self-renewal.
In both mice and a Phase 1 human clinical trial, long periods of not eating significantly lowered white blood cell counts. In mice, fasting cycles then “flipped a regenerative switch,” changing the signaling pathways for hematopoietic stem cells, which are responsible for
A team of researchers has brought the end of diabetes closer to reality by announcing a new breakthrough that could lead directly to a cure and not just a treatment for the disease.
The scientists discovered a protein that activates the maturation process in vitro, overcoming this longstanding obstacle in diabetes therapy development.
“In a dish, with this one switch, it’s possible to produce a functional human beta cell that’s responding almost as well as the natural thing,” says senior author Ronald Evans of the Salk Institute. “This has been a major blockade, and overcoming it has been a major challenge