IFATS Recommendations for FDA Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products
International Federation of Adipose Therapeutics and Sciences (IFATS) 45 Lyme Road – Suite 304 Hanover, NH 03755 USA Tel: 1-603-643-2325, Fax: 1-603-643-1444 September 26, 2016 Division of Dockets Management (HFA–305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: FDA-2014-D-1856 – Comments to 2014-2015 Draft Guidance regarding: Docket
Researchers from the Medical University of South Carolina (MUSC) and the University of Pennsylvania have discovered a new methodology for purifying liver cells generated from induced pluripotent stem cells (iPSCs) that could facilitate progress toward an important clinical goal: treating patients with disease-causing liver mutations by transplanting unmutated liver cells derived from their own stem
Scientists from the U.K. and Sweden have discovered a new method of creating human stem cells that could solve the problem of meeting large-scale production needs, allowing researchers to fully realize the potential of stem cells for understanding and treating disease. Human pluripotent stem cells are undifferentiated cells that have the unique potential to develop
The term muscular dystrophy (MD) refers to a group of disorders in which a genetic abnormality causes muscles responsible for controlling movement to become weak, and muscle mass to be lost. These inherited disorders usually affect voluntary (skeletal) muscles, although weakness can also extend to the muscles that control respiration and swallowing. Given that the genetic
Photo: iPS cells feature – reprogrammed stem cells: Credit: Moscow Institute of Physics and Technology Russian researchers have concluded that reprogramming does not create differences between reprogrammed and embryonic stem cells. Stem cells are specialized, undifferentiated cells that can divide and have the remarkable potential to develop into many different cell types in the body during early life
Stem Cell Research Goes Crimson: International Leader in Stem Cell Research Named New Dean of Harvard Medical School
George Q. Daley, MD, PhD, Harvard Medical School’s newly appointed dean, led dozens of international colleagues in developing ethical guidelines for stem cell research. On March 9, 2009, President Barack H. Obama issued Executive Order 13505: Removing Barriers to Responsible Scientific Research involving Human Stem Cells, stating that the Secretary of Health and Human Services, through
Where do adult stem cells come from? Adult stem cells receive much interest in the scientific community thanks to their ability to self-renew and generate numerous types of cells and tissues. There are two categories of stem cells: embryonic and adult. Unlike embryonic stem cells, which have the ability to differentiate into more than one
Healing damaged lungs with stem cells. A New study published by scientists from the Weizmann Institute of Science suggests that stem cells may be used for repairing damaged lung tissue. This discovery gives new hope for treating conditions like bronchitis, asthma, cystic fibrosis or emphysema, which affect more than 35 million Americans and are the second
The Language of Stem Cell Medicine: What are They? What Makes Them so Special? And What do all Those Acronyms Mean?
Stem cell medicine is based on the concept that physicians can harness the body’s own reserves to heal itself, rather than relying exclusively on drugs or invasive surgical procedures. Stem cell medicine works by deals engineering human stem cells to replace or restore damaged or diseased organs or tissue, or establish normal function in them. While
Adipose stem cells (pictured) harvested from body fat. (Photo: Genetic Engineering & Biotechnology News). The discovery of abundant stem cell populations in body fat tissue changed everything the medical community thought it knew about stem cells overnight. Now, adipose stem cell therapies are driving the plastic and cosmetic surgery industries, and demand among patients keeps
Chuck Dandridge, a Mansfield, Texas resident, became the first adult in the U.S. to receive a newly modified stem cell transplant that uses genetically engineered blood cells from a family member. The milestone was announced by researchers at UT Southwestern Medical Center’s Harold C. Simmons Comprehensive Cancer Center in Dallas, where the procedure was performed.
A new discovery by researchers on how to activate lab-grown beta cells to mature into functioning cells that produce and release insulin in response to glucose take a significant step toward a cell therapy treatment for diabetes. Difficulties in manipulating beta cells derived from human stem cells to mature beyond the precursor stage into fully