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Cellular & Gene Therapy Products – Food and Drug Administration

Posted: November 3, 2013 at 5:47 pm

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The Center for Biologics Evaluation and Research (CBER) regulates cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. CBER uses both the Public Health Service Act and the Federal Food Drug and Cosmetic Act as enabling statutes for oversight.

Cellular therapy products include cellular immunotherapies, and other types of both autologous and allogeneic cells for certain therapeutic indications, including adult and embryonic stem cells. Human gene therapy refers to products that introduce genetic material into a persons DNA to replace faulty or missing genetic material, thus treating a disease or abnormal medical condition.

Although some cellular therapy products have been approved, CBER has not yet approved any human gene therapy product for sale. However, the amount of cellular and gene therapy-related research and development occurring in the United States continues to grow at a fast rate. CBER has received many requests from medical researchers and manufacturers to study cellular and gene therapies and to develop cellular and gene therapy products. In addition to regulatory oversight of clinical studies, CBER provides proactive scientific and regulatory advice to medical researchers and manufacturers in the area of novel product development.

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Journal of Stem cells & Regenerative Medicine; JSRM- ISSN Number …

Posted: November 3, 2013 at 5:46 pm

The Journal of Stem cells and Regenerative Medicine (JSRM) is a fully free access exclusive Online Journal covering areas of Basic Research, Translational work and Clinical studies in the specialty of Stem Cells and Regenerative Medicine including allied specialities such as Biomaterials and Nano technology relevant to the core subject. This has also been endorsed by the German Society for Stem Cell Research(GSZ).

The JSRM issues are published regularly and articles pertaining to Stem cells and Regenerative Medicine as well as related fields of research are considered for publication

This Online Journal conceived and run by Clinicians and Scientists, originally started for the student community with reputed members in the advisory/editorial boards, has now been accepted to be the official organ of GSZ is reaching millions of Researchers, Cliniciansand Students all over the world, as it is a FREE Journal

Current activities of JSRM

1. Journal issues: will be published online and to subscribers (FREE) extracts will be sent by email 2. Weekly updates on happenings in the Stem Cell World with email updates to subscribers.

NEWS

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Journal of Stem cells & Regenerative Medicine; JSRM- ISSN Number ...

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PURTIER Placenta Live Stem Cell Therapy (CHINESE) – Video

Posted: November 3, 2013 at 5:45 pm


PURTIER Placenta Live Stem Cell Therapy (CHINESE)
??? PURTIER Placenta ???????? If you have other enquiries, please contact us at +65 8200 8227 Email: TrueStemCell@gmail.com PURTIER Placenta Live Stem Cell T...

By: Kim Purtier Placenta

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PURTIER Placenta Live Stem Cell Therapy (CHINESE) - Video

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Adult Stem Cell Enhancer by Dr. Riordan, Chinese subtitle. – Video

Posted: November 3, 2013 at 11:41 am


Adult Stem Cell Enhancer by Dr. Riordan, Chinese subtitle.
Consistently Increase of 50-100% Bone Marrow stem cells. Dr. Riordan Introduces Adult Stem cell Enhancer From RBC Life #39;s Stem-Kine with Dr. Clinton Howard an...

By: Adam Kee

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Adult Stem Cell Enhancer by Dr. Riordan, Chinese subtitle. - Video

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New Stem Cells Go Back Further – Video

Posted: November 2, 2013 at 8:41 pm


New Stem Cells Go Back Further
A team at the Weizmann Institute has created iPS cells that are completely "reset" to the earliest possible state and maintained them in that state. In the v...

By: Weizmann Institute of Science

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New Stem Cells Go Back Further - Video

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Paul Lucassen (UvA) on Stem Cells and Neurogenesis – Video

Posted: November 2, 2013 at 8:41 pm


Paul Lucassen (UvA) on Stem Cells and Neurogenesis
Prof. dr. P.J. (Paul) Lucassen is group leader of the Research Group "Structural and Functional Plasticity of the Nervous System" at the University of Amsterdam (The Netherlands)

By: Muus de Haan

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Stem Cells – Types, Uses, and Therapies – MedicineNet

Posted: November 1, 2013 at 8:48 pm

What are stem cells?

Stem cells are cells that have the potential to develop into many different or specialized cell types. Stem cells can be thought of as primitive, "unspecialized" cells that are able to divide and become specialized cells of the body such as liver cells, muscle cells, blood cells, and other cells with specific functions. Stem cells are referred to as "undifferentiated" cells because they have not yet committed to a developmental path that will form a specific tissue or organ. The process of changing into a specific cell type is known as differentiation. In some areas of the body, stem cells divide regularly to renew and repair the existing tissue. The bone marrow and gastrointestinal tract are examples areas in which stem cells function to renew and repair tissue.

The best and most readily understood example of a stem cell in humans is that of the fertilized egg, or zygote. A zygote is a single cell that is formed by the union of a sperm and ovum. The sperm and the ovum each carry half of the genetic material required to form a new individual. Once that single cell or zygote starts dividing, it is known as an embryo. One cell becomes two, two become four, four become eight, eight to sixteen, and so on; doubling rapidly until it ultimately creates the entire sophisticated organism. That organism, a person, is an immensely complicated structure consisting of many, many, billions of cells with functions as diverse as those of your eyes, your heart, your immune system, the color of your skin, your brain, etc. All of the specialized cells that make up these body systems are descendants of the original zygote, a stem cell with the potential to ultimately develop into all kinds of body cells. The cells of a zygote are totipotent, meaning that they have the capacity to develop into any type of cell in the body.

The process by which stem cells commit to become differentiated, or specialized, cells is complex and involves the regulation of gene expression. Research is ongoing to further understand the molecular events and controls necessary for stem cells to become specialized cell types.

Stem Cells - Experience Question: Please describe your experience with stem cells.

Stem Cells - Umbilical Cord Question: Have you had your child's umbilical cord blood banked? Please share your experience.

Stem Cells - Available Therapies Question: Did you or someone you know have stem cell therapy? Please discuss your experience.

Medical Author:

Melissa Conrad Stppler, MD, is a U.S. board-certified Anatomic Pathologist with subspecialty training in the fields of Experimental and Molecular Pathology. Dr. Stppler's educational background includes a BA with Highest Distinction from the University of Virginia and an MD from the University of North Carolina. She completed residency training in Anatomic Pathology at Georgetown University followed by subspecialty fellowship training in molecular diagnostics and experimental pathology.

Medical Editor:

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Stem Cells - Types, Uses, and Therapies - MedicineNet

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What are Stem Cells? – Medical News Today

Posted: November 1, 2013 at 8:48 pm

home stem cell research all about stem cells what are stem cells?

Stem cells are a class of undifferentiated cells that are able to differentiate into specialized cell types. Commonly, stem cells come from two main sources:

Both types are generally characterized by their potency, or potential to differentiate into different cell types (such as skin, muscle, bone, etc.).

Adult or somatic stem cells exist throughout the body after embryonic development and are found inside of different types of tissue. These stem cells have been found in tissues such as the brain, bone marrow, blood, blood vessels, skeletal muscles, skin, and the liver. They remain in a quiescent or non-dividing state for years until activated by disease or tissue injury.

Adult stem cells can divide or self-renew indefinitely, enabling them to generate a range of cell types from the originating organ or even regenerate the entire original organ. It is generally thought that adult stem cells are limited in their ability to differentiate based on their tissue of origin, but there is some evidence to suggest that they can differentiate to become other cell types.

Embryonic stem cells are derived from a four- or five-day-old human embryo that is in the blastocyst phase of development. The embryos are usually extras that have been created in IVF (in vitro fertilization) clinics where several eggs are fertilized in a test tube, but only one is implanted into a woman.

Sexual reproduction begins when a male's sperm fertilizes a female's ovum (egg) to form a single cell called a zygote. The single zygote cell then begins a series of divisions, forming 2, 4, 8, 16 cells, etc. After four to six days - before implantation in the uterus - this mass of cells is called a blastocyst. The blastocyst consists of an inner cell mass (embryoblast) and an outer cell mass (trophoblast). The outer cell mass becomes part of the placenta, and the inner cell mass is the group of cells that will differentiate to become all the structures of an adult organism. This latter mass is the source of embryonic stem cells - totipotent cells (cells with total potential to develop into any cell in the body).

In a normal pregnancy, the blastocyst stage continues until implantation of the embryo in the uterus, at which point the embryo is referred to as a fetus. This usually occurs by the end of the 10th week of gestation after all major organs of the body have been created.

However, when extracting embryonic stem cells, the blastocyst stage signals when to isolate stem cells by placing the "inner cell mass" of the blastocyst into a culture dish containing a nutrient-rich broth. Lacking the necessary stimulation to differentiate, they begin to divide and replicate while maintaining their ability to become any cell type in the human body. Eventually, these undifferentiated cells can be stimulated to create specialized cells.

Stem cells are either extracted from adult tissue or from a dividing zygote in a culture dish. Once extracted, scientists place the cells in a controlled culture that prohibits them from further specializing or differentiating but usually allows them to divide and replicate. The process of growing large numbers of embryonic stem cells has been easier than growing large numbers of adult stem cells, but progress is being made for both cell types.

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What are Stem Cells? - Medical News Today

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CellTherapyNews — Cell Therapy News Home

Posted: November 1, 2013 at 8:47 pm

Human Induced Pluripotent Stem Cell-Derived Cortical Neurons Integrate in Stroke-Injured Cortex and Improve Functional Recovery At two months after transplantation into a stroke-damaged rat cortex, cortically fated cells showed less proliferation and more efficient conversion to mature neurons with morphological and immunohistochemical characteristics of a cortical phenotype and higher axonal projection density as compared with non-fated cells. [Brain] Abstract| Press Release

Inhibition of Plasminogen Activator Inhibitor Type-1 Activity Enhances Rapid and Sustainable Hematopoietic Regeneration Genetic disruption of the plasminogen activator inhibitor-1 (PAI-1) gene, or pharmacological inhibition of PAI-1 activity, significantly improved the myeloablation-related mortality and promoted rapid hematopoietic recovery after hematopoietic stem cell transplantation through the induction of hematopoiesis-promoting factors. [Stem Cells] Abstract

WKYMVm-Induced Activation of Formyl Peptide Receptor 2 Stimulates Ischemic Neovasculogenesis by Promoting Homing of Endothelial Colony Forming Cells Researchers investigated the effects of WKYMVm, a selective formyl peptide receptor 2 agonist isolated by screening synthetic peptide libraries, on homing ability of endothelial colony forming cells and vascular regeneration of ischemic tissues. [Stem Cells] Abstract

TRIM5? Variations Influence Transduction Efficiency with Lentiviral Vectors in Both Human and Rhesus CD34+ Cells In Vitro and In Vivo Investigators examined whether TRIM5? could account for variations in transduction efficiency using both an established rhesus gene therapy model and human CD34+ cell culture. Evaluation of TRIM5? genotypes (Mamu-1, -2, -3, -4, -5, and TrimCyp) in 16 rhesus macaques that were transplanted with transduced CD34+ cells showed a significant correlation between TRIM5? Mamu-4 and high gene marking in both lymphocytes and granulocytes six months after transplantation. [Mol Ther] Abstract

Stem Cells Derived from Tooth Periodontal Ligament Enhance Functional Angiogenesis by Endothelial CellsIn comparison to mesenchymal stem cells and stem cells derived from tooth pulp tissues, researchers determined if periodontal ligament of teeth stem cells (PDLSCs) released soluble pro-angiogenic factors with the capacity to induce vessel formation by endothelial cells (ECs). Next, the ability of PDLSCs to modulate angiogenesis was examined through their co-transplantation with ECs in subcutaneous sites of immunocompromised mice. [Tissue Eng Part A] Abstract

Transplantation of Insulin-Secreting Cells Differentiated from Human Adipose Tissue-Derived Stem Cells into Type 2 Diabetes Mice Investigators evaluated the efficacy of cell therapy using insulin-secreting cells differentiated from human eyelid adipose tissue-derived stem cells into type 2 diabetes mice. [Biochem Biophys Res Commun] Abstract

Mesenchymal Stem Cells and Endothelial Progenitor Cells Stimulate Bone Regeneration and Mineral DensityResearchers quantified extra-cortical bone augmentation and tissue mineral density following co-transplantation of peripheral blood derived endothelial progenitor cells and bone marrow derived mesenchymal stem cells by micro computed tomography. [J Periodontol] Abstract

Improved Preparation of Acellular Nerve Scaffold and Application of PKH26 Fluorescent Labeling Combined with In Vivo Fluorescent Imaging System in Nerve Tissue Engineering Scientists prepared a novel acellular nerve scaffold by the technique of hypotonic buffer combined with freeze-drying, and used PKH26 fluorescent labeling combined with an in vivo fluorescent imaging system to evaluate the biological behavior of tissue-engineered nerves in vitro and in vivo. [Neurosci Lett] Abstract

mTORC1 Targets the Translational Repressor 4E-BP2, but Not S6 Kinase 1/2, to Regulate Neural Stem Cell Self-Renewal In Vivo Researchers found that genetically decreasing mammalian target of rapamycin complex 1 (mTORC1) activity in neonatal neural stem cells prevented their differentiation, resulting in reduced lineage expansion and aborted neuron production. [Cell Rep] Abstract| Graphical Abstract | Press Release

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cell therapy – definition of cell therapy in the Medical …

Posted: November 1, 2013 at 8:47 pm

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