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Stem-cell therapy uses stem cells to treat or prevent a disease or condition. [1] As of 2024, the only FDA-approved therapy using stem cells is hematopoietic stem cell transplantation. [2] [3] This usually takes the form of a bone marrow or peripheral blood stem cell transplantation, but the cells can also be derived from umbilical cord blood.
The Center for Stem Cell and Regenerative Medicine (CSCRM) is a medical research institution specializing in stem cell and other cell therapy research and treatments, located in Cleveland, Ohio. They specialize in basic and clinical research programs, biomedical and tissue engineering programs, and the development and administration of new ...
Examples include the injection of stem cells or progenitor cells obtained through directed differentiation (cell therapies); the induction of regeneration by biologically active molecules administered alone or as a secretion by infused cells (immunomodulation therapy); and transplantation of in vitro grown organs and tissues (tissue engineering).
A regenerative medicine therapy is defined in section 506(g)(8) of the FD&C Act to include cell therapies, therapeutic tissue engineering, human cell and tissue products. Under the FDA's interpretation, gene therapies and genetically modified cells that have a lasting effect, such as CAR-T antitumor therapies, may also qualify as regenerative ...
The California Institute for Regenerative Medicine (CIRM) is a state agency that supports research and education in the fields of stem cell and gene therapiesIt was created in 2004 after 59% of California voters approved California Proposition 71: the Research and Cures Initiative, [1] which allocated $3 billion to fund stem cell research in California.
Marrow-nucleated cells are used every day in regenerative orthopedics. The knee microfracture surgery technique relies on the release of these cells into a cartilage lesion to initiate fibrocartilage repair in osteochondral defects. [13] In addition, this cell population has also been shown to assist in the repair of non-union fractures. [14]
United States of America v. Regenerative Sciences, LLC, 741 F.3d 1314 (D.C. Cir. 2014), [1] was a decision in the United States Court of Appeals for the District of Columbia Circuit filed on February 4, 2014 concerning more than minimally manipulated cell therapies and whether they are considered part of medical practice or a drug, the latter subjecting it to regulation under the Food and Drug ...
The fundamental assertion of those who oppose embryonic stem cell research is the belief that human life is inviolable, combined with the belief that human life begins when a sperm cell fertilizes an egg cell to form a single cell. The view of those in favor is that these embryos would otherwise be discarded, and if used as stem cells, they can ...
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