FDA Compliant Stem Cell Manufacturing Process Made Available Free of Charge

In recent years, human-induced pluripotent stem cell (“IPS cell”) research has emerged as a treatment modality that potentially avoids the ethical objections connected with embryonic stem cells.

First produced in 2007, IPS cells are differentiated so that they serve a specific function, like dopamine production, before being implanted. Undifferentiated cells can form tumors called teratomas and therefore, differentiating cells is key to enhancing safety.

Biotech company, Lonza, has published a paper detailing the company’s stem cell manufacturing process and announced the availability of its IPS cell banks. In the paper, the company states: “To our knowledge, no fully cGMP-compliant cell line has been generated where the entire manufacturing process, from tissue sourcing to cell expansion and banking processes as well as documentation, raw materials, staff training, cell therapy facility, and quality control (QC) testing, was validated.”

The design will be compliant with FDA’s Good Manufacturing Practices and the basic process is available without charge, though the detailed version (the one that produced Lonza’s cell banks) is still proprietary.

Source: http://www.sandiegouniontribune.com/news/2015/sep/24/induced-pluripotent-stem-cell-lonza-manufacturing/


New Research from Johns Hopkins University Explores How Stem Cells are Affected by their Surroundings

Researchers from Johns Hopkins University studied how immediate surroundings affect stem cells. Stem cells can develop into differentiated cells from their original state and therefore, hold a “promise of being used to replace damaged organs and muscle.” This study showcases how the application of stem cells could be greater, with more “reliable techniques to control how they take on specialized functions.” It was discovered that an enzyme, called aminopeptidase, located in the stem cell niche, helps keep stem cells in their original state by promoting specialized cells to transform into stem cells. This aids in the creation of more stem cells. However, it is still unclear how the stem cell niche performs this role.

Nevertheless, the results of this study could be crucial to future advances in medicine. Because it is possible for cell fate to change, in that specialized cells become stem cells by aminopeptidase, either from cues from the stem cell niche or randomly, then it could also be possible that random cell fate change can be a leading cause of cancer or other diseases.

Source: http://www.sciencedaily.com/releases/2015/10/151007185037.htm

Plastic Surgeons Consider Stem Cell Therapy a Part of Industry’s Future

This week in San Diego, California, plastic surgeons will meet to discuss the future of their industry. The head of the American Society of Plastic Surgeons, Dr. Bob Murphy, states that stem cell therapy can be used in elective procedures, as well as reconstructive procedures. Dr. Murphy went on to say that perhaps, one day, stem cells might make it possible for patients to regrow breasts after mastectomies.

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Cryo-Save Stores Upwards of 250,000 Stem Cell Samples

Cryo-Save Group N.V. is the premier international stem cell storage company. It has been 25 years since the first umbilical cord blood transplant, and the company now stores more than 250,000 stem cell samples within its walls. Cryo-Save has the storage capacity for up to one million stem cell samples. Also, it is capable of processing up to 30,000 stem cell samples per year. On its website, Cryo-Save states that stem cell therapy is capable of treating many diseases and will be able to treat many more in the future.


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U.S. Scientists Win Nobel Prize

Professor of biomedical sciences at Yale University, James Rothman, professor of molecular and cellular biology at the University of California, Berkeley, Randy Schekman and physiology professor at Stanford, Thomas C. Suedhof have been granted a $1.25 million dollar prize by the Nobel Assembly. The three individuals will share the prize for their research which “revealed the exquisitely precise control system for the transport and delivery of cellular cargo.” The discoveries have led to better ways to diagnose patients, because disturbances in the transport system contribute to dangerous medical conditions, such as diabetes, neurological diseases and immunological disorders.


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To read about the impact of budget cuts on the work of scientists like these Nobel Prize winners, click here.

Nanomaterials Mimic Human Tissue to Create Cartilage

Joint injuries are difficult to treat because cartilage does not have the ability to heal itself. Researchers worldwide have been searching for a way to manipulate stem cell growth in order to repair cartilage and joints. However, the research is still in its early stages because researchers have difficulty getting the stem cells to remain and survive at the desired tissue location. Therefore, labs have now begun to use new nanomaterials, which mimic the chemical and physical characteristics of human tissue, in order to create scaffolds that will support and control the formation of cartilage.

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Scientists Grow Primitive Human Brain Tissue Using Stem Cells

Researchers at the Austrian Academy of Sciences used stem cells to grow “primitive human brain tissue.” The scientists intend to use the tissue to study the early development of organs and medical disorders. The tissue could provide a much more useful and informative way to conduct research on the human brain; formerly, scientists conducted such research using the brain tissue of mice. A mouse’s brain does not provide an adequate model for the study of the human brain because there are vast differences in the way the brains of the two species develop. In addition, the scientists suggested that the primitive human brain tissue will allow researchers to avoid some animal experimentation.

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Research May Lead to New Treatments for Lethal Cancers

Neuroblastoma is a cancer of the nervous system that occurs in children, and is almost always fatal. Fifteen percent of cancer deaths in children result from neuroblastoma. Often, in the most severe cases of neuroblastoma, the gene CHD5 is inactive. A study conducted by Johan Holmberg, PhD, at the Ludwig Institute for Cancer Research Stockholm, examined CHD5’s role as a tumor suppressor in order to learn how it operates in healthy tissue.  The researchers thwarted the activity of CHD5 in the brains of fetal mice; their findings indicate that, in order for a cell to transition from a stem cell into a mature neuron, CHD5 must be active. The findings could lead to new and more effective ways to treat neuroblastoma, as well as gliobastoma multiforme, which is the most common and lethal form of brain cancer in adults.

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Would You Like Your Burger Rare, Medium, Well or Made of Stem-Cells?

Two volunteers sampled a burger made from stem cells in England; a meal worth approximately $331,400, and three months of laboratory work. According to one of the volunteers, the burger was “close to meat,” and the other claimed that the lack of ketchup made his burger-eating experience unnatural. The stem-cell burger, otherwise known as “schmeat,” comes from stem cells that are harvested from a cow’s shoulder. The stem cells are then converted to strips of muscle in a laboratory. Currently the world demand for beef exceeds its supply. So, some look to schmeat as the future of meat production. Unfortunately, it seems at present that the concept is more palatable than the burger itself.

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Potential Cure for Blindness on the Horizon?

Animal trials showed that cells in the retina that detect light may be repaired with stem cell therapy. The retina reacts to light, converts the light into an electronic signal, and sends the signal to the brain. However, cells within the retina that are responsible for this function may die for a variety of reasons, some of which include: age-related macular degeneration; and Stargart’s disease. According to Moorfields Eye Hospital and University College London, there is a high probability that human trials could be next. The study is considered a “huge leap” toward better treatments for  blindness and may have wider implications for the field of stem cell research. 

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