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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and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852   Re: FDA-2014-D-1856 - Comments to 2014-2015 Draft Guidance regarding: Docket FDA-2014-D-1584: “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception; Draft Guidance for Industry”; Docket FDA-2014-D-1696: “Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Draft Guidance for Industry and Food and Drug Administration Staff”; Docket FDA-2014-D-1856: “Human Cells, Tissues, and Cellular and Tissue-Based Products from Adipose Tissue: Regulatory Considerations; Draft Guidance for Industry”; Docket FDA-2015-D-3581: “Homologous Use of Human Cells, Tissues, and Cellular and Tissue- Based...

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Scientists Confirm Reprogrammed Adult Stem Cells Identical to Embryonic Stem Cells

REPROGRAMMED STEM CELLS

Click on photo (at left) to enlarge 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 and growth. They serve as a sort of internal repair system in many tissues, dividing essentially without limit to replenish other cells. When a stem cell divides, each new cell has the potential either to remain a stem cell or become another more specialized cell type, such as a muscle cell, a red blood cell, or a brain cell. Scientists distinguish several types of stem cells—pluripotent stem cells...

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Breakthrough in scaling up life-changing stem cell production

human stem cells

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 into all the different types of cells in the body. With applications in disease modeling, drug screening, regenerative medicine and tissue engineering, there is already an enormous demand for these cells, and that demand will continue grow as their use in clinical settings and the pharmaceutical industry increases. [caption id="attachment_15591" align="alignright" width="300"] Human embryonic stem cell line HUES1 grown in the new conditions E8+Inter-alpha-inhibitor and imaged for stem cell marker Oct4 (green) and...

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Purest Liver-like Cells to Date Generated from Induced Pluripotent Stem Cells (iPSCs)

liver stem cell research

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 cells. This new technique follows previous attempts to generate liver-like cells from stem cells, which have yielded heterogeneous cell populations with little similarity to diseased livers in patients. [caption id="attachment_15584" align="alignright" width="300"] Image: induced pluripotent stem cells expressing a characteristic cell surface protein called SSEA4 (green).Credit: Image courtesy of Stephen A. Duncan, Ph.D., at the Medical University of South Carolina[/caption] The National Heart, Lung, and Blood Institute (NHLBI)'s Next Generation Genetic Association Studies Program...

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The Language of Stem Cell Medicine: What are They? What Makes Them so Special? And What do all Those Acronyms Mean?

stem cell medicine

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 regenerative medicine primarily includes therapies a that utilize stem cells, the term is also used to describe therapies that use progenitor cells, used for many decades in the form of bone marrow transplants, as well as other cellular products such as platelet-rich plasma (PRP). While both PRP and progenitor cells are widely used in clinical settings, stem cell therapies are still playing catch-up. PRP is used to treat orthopedic injuries and...

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Adipose Stem Cell Therapies are Revolutionizing Plastic Surgery, and Demand is High

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 rising. In 2001, researchers and plastic surgeons from the University of Pittsburgh discovered that human fat tissue is a very rich source of mesenchymal stem cells (MSCs),  multipotent stromal cells that can differentiate into a variety of cell types. When their findings were published in Tissue Engineering Journal, the discovery stirred quite an epiphany in the medical and scientific community—until then, adult MSCs were predominantly believed to be strictly a bone marrow product. [caption id="attachment_15378" align="alignright" width="300"]...

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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 the Director of the National Institute of Health (NIH), may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law. Internal NIH policies and procedures, consistent with Executive Order 13505 and these Guidelines, govern the conduct of intramural NIH stem cell research. A prominent stem cell researcher has been named the new dean of Harvard Medical School, the...

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Texas Man Becomes First Adult in the U.S. to Receive Updated Stem Cell Transplant to Treat Leukemia

stem cell transplant

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. Dandridge’s medical journey began in 2013, with a routine doctor’s visit to check his cholesterol levels; lab tests revealed low blood counts and further testing confirmed Dandridge’s diagnosis of myelodysplastic syndrome, also called pre-leukemia or MDS. By 2014, the leukemia had progressed to acute myeloid leukemia (AML), which, according to the National Cancer Institute,  affects more than 20,000 Americans annually. Dandridge was referred to UT Southwestern's Simmons Cancer Center, where his leukemia...

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Insulin-producing Stem Cells Grown in the Lab Mark a New Era in Stem Cell Therapies for Diabetes

insulin-producing pancreatic beta cells

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 functioning insulin releasers has been an on-going challenge for researchers.. However, researchers from the Salk Institute for Biological Studies and a team of researchers  have achieved this goal with lab-grown beta cells by activating a protein called estrogen-related receptor γ (ERRγ). Their study findings were recently published in the journal Cell Metabolism. Self-renewing capacity of human pluripotent stem cells (hPSCs) Ronald Evans, senior author of the study, titled, “ERRγ Is required for the Metabolic...

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Amazing Stem Cell Research Breakthroughs You Never Heard of

Scientists have been studying stem cells for decades, and many of their findings, all pretty remarkable, aren’t widely circulated. Periodically, we will share one of these stem cell research breakthroughs here on this blog. Summary: The skin renews, heals wounds, and regenerates the hair that covers it thanks to a small group of stem cells. These cells continually produce new ones, which appear on the skin surface after a few days. A 2008, released online July 28, 2016, has identified two proteins that are fundamental to conserve skin stem cells, and shows that without these proteins these cells are lost. Researchers find that these proteins, Dnmt3a and Dnmt3b, are altered similarly to tumor cells found in leukemia, lung cancer and colon cancer, which may help researchers...

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