How does the U.S. FDA regulate cell therapies? (351 vs 361 Products) 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). According to the FDA, the Center for Biologics Evaluation and Research (CBER) regulates: Cellular

What is regenerative medicine?

Regenerative medicine is the exciting cutting-edge “medicine of the future” which holds the hope & the promise of efficacy which revolves around the ability of human tissue to be repaired, replaced, and healed (regenerated) once human tissues and organs are damaged or diseased. Regenerative therapies aid and supplement the natural healing mechanisms of the body.

We want to talk here about the fascination that stem cells produce over scientists and lay people. Ever since we heard about this microscopic buddies for the first time, we started imagining endless possibilities for treatments and, why not: cures. So scientists went right to work. One of the objectives was to find ways to

So we have been in the regenerative medicine specialty for about 8 years. Just like pretty much everyone, we started by using Platelet Rich Plasma. We learnt about it, we were fascinated by it and we treated our patients with it. Patients loved and so did we. ‘ PRP, if obtained and used correctly is

Hair loss is very common, with tens of millions, if not hundreds of millions of people all over the world suffering from it. Hundreds of thousands of people decide to utilize hair restoration therapy, as well as other procedures in order to try to get at least some of their former hair back. Although some

Here at Adimarket, we sell equipment to practices that are willing and able to add PRP and stem cell therapies to their lineup. The equipment we offer is among the best, and we have helped hundreds of doctors and practices to offer PRP and stem cell therapies. However, we also provide marketing services above that

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and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852   Re: FDA-2014-D-1856 – Comments to 2014-2015 Draft Guidance regarding: Docket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

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

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