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

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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Regeneration of Damaged Spinal Cord Possible According to Chinese Study

The China Spinal Cord Injury Network (ChinaSCINet) reports that it used stem cells from umbilical cord blood transplants in order to regrow nerve fibers in patients with spinal cord injuries. ChinaSCINet claims that the combination of umbilical cord blood transplants and physical therapy allowed 15 out of 20 immobile patients to walk again, approximately seven years after injuring their spinal cords. ChinaSCINet completed the second round of tests and has applied for approval for the final phase of testing. The company hopes to begin the final trial in the fall. The third and final phase of testing would involve 120 Chinese patents, and 120 patients from the United States, Norway and India.

If the trial is successful China would become the center for stem cell therapies according to some. The issue of using stem cells in the United States is highly controversial; however China is “investing heavily into stem-cell research.” Read more about the study here.

Type 2 Diabetes Treated Successfully with Self-Donated Bone Marrow Stem Cells

A study conducted in India revealed that patients with Type 2 diabetes required less insulin after receiving transplanted, self-donated bone marrow stem cells. Researchers have an increasing interest in using self-donated bone marrow stem cells in the treatment of Type 2 diabetes. However they have not explored the full potential of stem cell therapy yet.  Read more here.

Stanford Researchers Examine Regenerative Capacity of Stem Cells for Tissue Repair and Renewal

The process of hair growth intrigues researchers, because understanding the process may provide insights about using stem cells  for tissue “repair and renewal” more broadly. Recently, Genes and Development published a study performed by Stanford dermatologist Anthony Oro, MD, PhD, and his colleagues, with interesting implications for the field of regenerative medicine.

The study investigated stem cell activity in a mouse model of a human condition called “Timothy’s Syndrome (TS).” Children with TS are born bald and remain so for many months or even years, have cardiac abnormalities, physical malformations and have a very low life expectancy. A TS patient has genetic mutations in a calcium channel that controls the timing of the heartbeat; however the patient will exhibit both cardiac arrhythmia and delays in hair growth. The study examined this genetic mutation, specifically the link between the lack of hair growth and the cardiac abnormality.

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