The Sugar Land company involved in Gov. Rick Perry's unlicensed adult stem-cell procedure is rife with basic manufacturing problems, according to the U.S. Food and Drug Administration. In a report one expert called a blow to the entire adult stem-cell industry, the FDA found that Celltex Therapeutics Corp. cannot guarantee the sterility, uniformity and integrity of stem cells it takes from people and then stores and grows for eventual therapeutic reinjection. "You have not performed a validation of your banking and thawing process to assure viability" of the stem cells, reads the April 27 report, meaning that the company cannot verify the cells are alive. The FDA report, which followed an April 16-27 inspection of Celltex, was released under the Freedom of Information Act Monday to the Houston Chronicle and a University of Minnesota bioethicist who complained in February that Celltex is a potential danger to patients and not in compliance with federal law. The report, partially redacted, was not accompanied by a warning letter. A former FDA official who asked not to be identified, however, said the deficiencies - 79 in all, from incorrectly labeled products to failed sterility tests - are so serious that Celltex risks being shut … Continue reading →

Optimal stem cell therapy delivery to damaged areas of the heart after myocardial infarction has been hampered by inefficient homing of cells to the damaged site. However, using rat models, researchers in France have used a magnet to guide cells loaded with iron oxide nanoparticles to key sites, enhancing the myocardial retention of intravascularly delivered endothelial progenitor cells. The study is published in a recent issue of Cell Transplantation (21:4), now freely available online. "Cell therapy is a promising approach to myocardial regeneration and neovascularization, but currently suffers from the inefficient homing of cells after intracavitary infusion," said Dr. Philippe Menasche of the INSERM U633 Laboratory of Surgical Research in Paris. "Our study was aimed at improving and controlling homing by loading human cord-blood-derived endothelial progenitor cells (EPCs) for transplant with iron oxide nanoparticles in order to better position and retain them in the hearts of myocardial-injured test rats by using a subcutaneously implanted magnet." The researchers found that the cells were sufficiently magnetic to be able to be remotely manipulated by a magnet subsequent to implantation. According to the researchers, an objective assessment of the technique to enhance the homing of circulating stem cells is the ability to track … Continue reading →

COLORADO SPRINGS, Colo.--(BUSINESS WIRE)-- HemoGenix announced today that FDA CBER has given HemoGenix its first Master File Number for an in vitro blood stem cell potency, quality and release assay (HALO-96 PQR) (1)for cellular therapy products(2)used for stem cell transplantation purposes. HALO-96 PQR is the first commercially available stem cell potency assay for cellular therapy products. It incorporates the most sensitive readout available to measure changes in the cells energy source (ATP) as a function of the potential for stem cells to proliferate. Potency and quality of stem cell therapeutic products are required to be measured prior to use to help predict the engraftment of the cells in the patient. At the present time, tests such as cell number, viability and a stem cell marker called CD34 are routinely used. However, none of these tests specifically measure stem cells and none determine the stem cell biological activity required for a potency assay. The only cell functionality test presently used in this field, especially for umbilical cord blood transplantation, is the colony-forming unit (CFU) assay, which is subjective, non-validated and has been used since the early 1970s. HALO-96 PQR changes this paradigm. It is particularly needed in the umbilical cord blood … Continue reading →

Researchers in Japan who evaluated the risks and efficacy of transplanting two varieties of stem cells into mouse cochlea have concluded that both adult-derived induced pluripotent stem (iPS) cells and mouse embryonic stem (ES) cells demonstrate similar survival and neural differentiation capabilities. However, there is a risk of tumor growth associated with transplanting iPS cells into mouse cochleae. Given the potential for tumorigenesis, they concluded that the source of iPS cells is a critical issue for iPS cell-based therapy. Their study is published in a recent issue of Cell Transplantation (21:4), now freely available online. "Hearing loss affects millions of people worldwide," said Dr. Takayuki Nakagawa of the Department of Otolaryngology, Graduate School of Medicine, Kyoto University, Japan. "Recent studies have indicated the potential of stem-cell based approaches for the regeneration of hair cells and associated auditory primary neurons. These structures are essential for hearing and defects result in profound hearing loss and deafness." The authors noted that embryonic stem cells have previously been identified as promising candidates for transplantation, however they have also been associated with immune rejection and ethics issues. Consequently, this study compared the survival and neural differentiation capabilities of ES and three clones of mouse iPS … Continue reading →

The Sugar Land company involved in Gov. Rick Perry's unlicensed adult stem-cell procedure is rife with basic manufacturing problems, according to the U.S. Food and Drug Administration. In a report one expert called a blow to the entire adult stem-cell industry, the FDA found that Celltex Therapeutics Corp. cannot guarantee the sterility, uniformity and integrity of stem cells it takes from people and then stores and grows for eventual therapeutic reinjection. "You have not performed a validation of your banking and thawing process to assure viability" of the stem cells, reads the April 27 report, meaning that the company cannot verify the cells are alive. The FDA report, which followed an April 16-27 inspection of Celltex, was released under the Freedom of Information Act Monday to the Houston Chronicle and a University of Minnesota bioethicist who complained in February that Celltex is a potential danger to patients and not in compliance with federal law. The report, partially redacted, was not accompanied by a warning letter. A former FDA official who asked not to be identified, however, said the deficiencies - 79 in all, from incorrectly labeled products to failed sterility tests - are so serious that Celltex risks being shut … Continue reading →

Optimal stem cell therapy delivery to damaged areas of the heart after myocardial infarction has been hampered by inefficient homing of cells to the damaged site. However, using rat models, researchers in France have used a magnet to guide cells loaded with iron oxide nanoparticles to key sites, enhancing the myocardial retention of intravascularly delivered endothelial progenitor cells. The study is published in a recent issue of Cell Transplantation (21:4), now freely available online. "Cell therapy is a promising approach to myocardial regeneration and neovascularization, but currently suffers from the inefficient homing of cells after intracavitary infusion," said Dr. Philippe Menasche of the INSERM U633 Laboratory of Surgical Research in Paris. "Our study was aimed at improving and controlling homing by loading human cord-blood-derived endothelial progenitor cells (EPCs) for transplant with iron oxide nanoparticles in order to better position and retain them in the hearts of myocardial-injured test rats by using a subcutaneously implanted magnet." The researchers found that the cells were sufficiently magnetic to be able to be remotely manipulated by a magnet subsequent to implantation. According to the researchers, an objective assessment of the technique to enhance the homing of circulating stem cells is the ability to track … Continue reading →