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Should stem cells be regulated by the U.S. Food and Drug Administration (FDA) as drugs? This is a complex question and one that the FDA has continued to refine over the past several years.
In the United States, cellular therapies are regulated by the FDA’s Office of Cellular, Tissue, and Gene Therapies (OCTGT) within the FDA Center for Biologics Evaluation and Research (CBER). [Read more…]
• The DOD studies seek to test the effectiveness of PLX-R18 as a novel medical countermeasure for Acute Radiation Syndrome (ARS) prior to and within 24 hours of exposure to high levels of radiation
• The DOD studies will be conducted in parallel with the ongoing ARS project with the NIH
HAIFA, ISRAEL, August 16, 2017— Pluristem Therapeutics Inc. (NASDAQ: PSTI) (TASE: PSTI), a leading developer of placenta-based cell therapy products, today announced that a pilot study of the company’s PLX-R18 cell therapy will be initiated by the U.S. Department of Defense’s (DOD) Armed Forces Radiobiology Research Institute (AFRRI), part of the Uniformed Services University of Health Sciences (USU). The study will examine the effectiveness of PLX-R18 as a treatment for Acute Radiation Syndrome (ARS) prior to, and within the first 24 hours of exposure to radiation. [Read more…]
Since the discovery of induced pluripotent stem cells (iPS cells) in 2006, a great deal of basic research has been done to understand how to produce, manipulate, and utilize the cell type. iPS cells are revolutionizing regenerative medicine, because they represent a potential route for producing patient-specific stem cells for research applications or clinical use. iPS cells also show great promise for phamaco-toxicological screening, by allowing disease modeling and safety assessment of potential new drugs.
iPS cells have the potential to transform drug discovery by providing physiologically relevant human cells for compound identification, target validation, compound screening, and tool discovery. They can be used to produce a wide variety of mature human cell types, allowing potential drug compounds to be screened in high-throughput systems using human cells.
Additionally, iPS cells allow for the creation of patient specific cell populations, facilitating in vitro drug testing that replicates the disease conditions of the patient population of interest. This approach facilitates early determination of whether a specific genetic population will respond well to a drug candidate, a process known as “personalized medicine.”
Currently, all but one of the clinical trials underway with iPS cells involve the creation and evaluation of iPS cell lines from specific patient population to determine whether the cell lines will be a good model for a disease of interest in a specific patient population. The only exception to this is Cynata’s clinical trial underway for GvHD in the UK that involves a MSC-derived iPS cell product. [Read more…]
Founded in 2007 by Rudolf Jaenisch with backing from Arch Venture Partners, Fate Therapeutics’ corporate headquarters are in San Diego, California. It also has a subsidiary in Ottawa, Canada. Fate Therapeutics is an innovative biotechnology company developing novel stem cell modulators and biologic or small molecule compounds that guide cell fate. [Read more…]
HOLLISTON, Mass., Aug. 7, 2017 /PRNewswire/ — Biostage Inc., (Nasdaq: BSTG), (“Biostage” or the “Company”), a biotechnology company developing bioengineered organ implants to treat cancer, congenital abnormalities and other life-threatening conditions of the esophagus, bronchus and trachea, today announced the use of Biostage’s Cellspan Esophageal Implant product candidate in a patient at a major U.S. hospital via an FDA-approved single-use expanded access application.
