FDA Approves Mayo Clinic’s Automated Bioreactor

The Food and Drug Administration (FDA) has approved a new platform developed by the Mayo Clinic’s Center for Regenerative Medicine that can mass produce stem cells in a way never done before. This is one of the first automated methods approved in the United States. Before this momentous approval, patient’s had to wait sometimes months for medical treatment that involved the creation of multiple stem cells. Now, stem cells are being manufactured in the billions in just a few days.

To understand the far-reaching effects of the FDA’s approval of the Mayo Clinic’s automated bioreactor, we must first look to understand the history of stem cell research and production.

Stem cells are – essentially – shape-shifters. They can develop and differentiate into other cells and repair and regenerate damaged tissue. Because of this, scientists and researchers are looking to stem cells to help treat a variety of conditions, from Parkinson’s and Alzheimer’s diseases, to spinal cord injuries, to Diabetes.

For a long time, the production and harvesting of stems cells has been a very labor-intensive process. Before the automated system, hundreds of hours of around-the-clock work over the course of several months only equated to the cultivation of enough cells for a few patients.

But it’s not just the speed of production that’s revolutionary. Before the Mayo Clinic’s automated bioreactor – which took over four years to develop – scientists needed stem cells from the patients themselves. Now, stem cells from other healthy individuals can be used in treating ailing patients.

“This may make treatments possible in cases where the patient’s own cells are not viable as therapy,” said Abba Zubair, M.D., Ph.D., medical director of Transfusion Medicine and the Human Cell Therapy Laboratory on the Florida campus. “In addition, because the cells can be produced in days instead of months, it may also make treatments available on short notice when they’re needed for acute care.”

The Mayo Clinic – a non-profit organization out of Jacksonville, Florida – was founded in 1889 and since then has been dedicated to finding solutions to transform medicine and surgery. With the automated bioreactor, they’ve succeeded in doing just that. So far, the scope of possibilities for stem cell research is limitless as it’s not just current patients that could benefit from the recent development. Given that stem cells can now be produced in the billions, they can rigorously test other possible treatments using stem cells.

“Although Mayo Clinic has been poised to scale up regenerative clinical trials, to date we did not have the capacity to support them. With this new technology, we now can develop phase II trials enrolling larger numbers of patients to fully test the efficacy of cell-based therapies, ” said Zubair.

They plan to use this new stem cell platform to advance therapies in degenerative diseases that, as of yet, have no cure.

Stems cells have already been proven to be vital in repairing tissue, skin, and bone. With the new, more efficient technology, the Mayo Clinic is looking to study and treat diseases like Arthritis that currently affects over 350 million people worldwide.


Stem Cell Research Bringing Doctors Closer than ever to HIV Cure

After 30 years and thanks to extensive stem cell research, scientists are closer than ever before to finding a cure for Human Immunodeficiency Virus, or HIV. Led by Dr. Scott Kitchen, an associate professor of hematology and oncology at UCLA’s David Geffen School of Medicine, the group of US scientists from California, Maine, and Washington have successfully engineered blood-forming stem cells that can carry genes capable of detecting and destroying HIV-infected cells.

But it’s not just that the stem cells were able to destroy the HIV-infected cells, they persisted in doing so for over two years without any negative effects. This equates to long-term immunity and the potential to completely eradicate the disease which, after 1981, quickly became the world’s leading infectious killer.

Kitchen received just over $1.7 million from California’s Stem Cell Agency to carry out his research. California has a special interest in the research as the state ranks second in the United States in cases of HIV. Over 170,000 people are infected, incurring healthcare costs which are being billed to the state. The total has continued to rise and now equates to over $1.8 billion per year.

California’s Stem Cell Agency maintains that “A curative treatment is a high priority. A stem cell based therapy offers promise for this goal, by providing an inexhaustible source of protected, HIV specific immune cells that would provide constant surveillance and potential eradication of the virus in the body.”

In the grant details, Kitchen identifies the potential impact of his research:

“The study will allow a potentially curative treatment for HIV infection, which currently doesn’t exist. This will eliminate the need to administer antiviral medication for a lifetime.”

According to his study published in the journal PLOS Pathogens, Kitchen’s curative treatment involves the use of a ‘optimized’ chimeric antigen receptor (CAR) gene that interferes with interactions between HIV and CD4 cells (white blood cells).When a part of the CAR molecule binds to HIV, it’s instructed to kill the HIV-infected cell. These CAR proteins proved highly effective as they killed HIV-infected cells throughout the lymphoid tissues and gastrointestinal tract, two major sites in HIV replication.

If Kitchen and his team are able to effectively kill off infected cells, they have the potential to save millions of those currently infected with HIV across the globe and can also prevent the virus from advancing into Acquired Immunodeficiency Syndrome, or AIDS. In both cases, the immune system is completely broken down. T-cells, which normally fight and prevent all kinds of bacteria and viruses in the body, are weakened and depleted allowing common and usually treatable infections to become deadly.

Throughout the 80’s and early 90’s, long before stem cell research, the number of people carrying HIV continued to climb as it continued to spread and in 1995, complications from AIDS became the leading cause of death for adults aged 25-44. Shortly thereafter, in 1997, the first truly effective treatment was developed. Highly active antiretroviral therapy (HAART) became the standard and there was a 47% decline in death rates.

By the early 2000’s, the World Health Organization set a goal to treat 3 million people and by 2010 there were 20 different treatment options available.  5.25 million people had treatment and over 1 million more were set to start treatment soon.

While these numbers are a massive improvement and the FDA (Food and Drug Administration) is continuing to approve and regulate HIV medical products, the disease is being slowed rather than halted. According to UNAIDS, over 35 million people are still currently living with HIV/AIDS.

Back in 2011, Kitchen co-authored a study about stem cell research in the treatment of HIV/AIDS in the journal Current Opinion in HIV and AIDS. In it, he said that stem cell-based strategies for treating HIV were “a novel approach toward reconstituting the ravaged immune system with the ultimate aim of clearing the virus from the body.”

Since then, he’s continued to reach higher towards that ultimate aim.

Stem cell treatments utilize patients’ own cells for testing on humans and stem cell advances provide the very necessary opportunity for large clinical trials. It is Kitchen’s hope – and it’s safe to assume the worlds’ hope – that stem cell innovation can one day effectively eliminate the disease, therefore preventing its spread, saving billions of dollars in healthcare costs, and – most importantly – saving lives.

Enhanced Culture System Allows Scientists to Quickly Derive Embryonic Stem Cells From Cows

Ever since embryonic stem (ES) cells were derived from mice in 1981, the scientific community has been looking to do the same with bovine ES cells. Now, 37 years after the cells were cultured from mice and 20 years after the cells were cultured from humans, they’ve finally captured and sustained the cells in their primitive state from a cow. In a study published in the journal Proceedings of the National Academy of Sciences, scientists at the University of California, Davis, detail how they were were able to enhance culture systems and derive stem cells with almost complete accuracy in just 3-4 weeks, a relatively quick turnaround time.

Access to these cells – which are able to develop into more than one mature cell or tissue type from muscle to bone to skin – could mean healthier, more productive livestock and could also give scientists and researchers an opportunity to model human diseases.the

ES cells are easily shaped and moulded and have a potentially unlimited capacity for self-renewal. This means that they’re extremely valuable in regenerative medicine and tissue replacement. In livestock and cattle, they offer the potential to create a sort of Super Cow that produces more milk and better meat, emits less methane, has more muscle, that adapts more easily to a warmer climate, and that is more resistant to diseases.

“In two and a half years, you could have a cow that would have taken you about 25 years to achieve. It will be like the cow of the future. It’s why we’re so excited about this,” author of the study Pablo Ross, an associate professor in the Department of Animal Science at UC Davis’ College of Agricultural and Environmental Sciences, told Science Magazine.

In order to enhance culture systems to sustain the ES cells, scientists at the Salk Institute in San Diego, California, had to expose ES cells to a new culture medium, a substance (sometimes a solid, sometimes a liquid, and sometimes a semi-solid) that’s designed to support the growth of microorganisms and cells. In this case, scientists used a protein to encourage cell growth and another molecule that hinders cells from separating or evolving.

“They used an accelerator and a brake at the same time,” George Seidel, a cattle rancher and a reproductive physiologist at Colorado State University in Fort Collins, told Science Daily.

In order for the enhanced culture systems to eventually lead to genetically superior cows, scientists will first have to augment these ES cells into the cattle’s gametes, or sperm and egg cells. The result would be endless genetic combinations, a sort of controlled evolution and accelerated natural selection. Of course, given that the evolution is taking place in a lab, each ‘generation’ would progress without any animals actually being born.

Ross maintains that “It could accelerate genetic progress by orders of magnitude”.

But it’s not just farmers and consumers that could benefit. The cows’ cells could help create larger models for studying human disease, something that mice simply couldn’t aid in due to their size. The science has also proved effective in deriving and sustaining cells from sheep. On scientists’ radars now: dogs.

Could Stem Cells Repair Loss of Smell?

A gradual loss or impairment of our sense of smell is a natural part of the normal ageing process. As we get older, many of us will experience a decline in our olfactory function, this will often result in a compromised or complete loss of smell. This in turn, affects the sense of taste. Loss of either, or both of these senses can significantly impact quality of life, and be hazardous to health and nutritional status.

This loss of smell is largely caused by a slow loss of stem cells in the nasal tissue that are present in young people, but lessen in number with age.

To date there have been no treatment options available to repair a person’s sense of smell.

Now, researchers at Tufts University School of Medicine in Boston are investigating the behaviour of stem cells related to the sense of smell in older people. Their research could be a step in the right direction to preventing deterioration and loss of smell in the future.

Regenerating nasal tissue

The research, led by Dr. James E. Schwob, managed to provide the first evidence that it is possible to regenerate nasal tissue in mice, therefore enlarging the population of adult stem cells.

Past research has shown that stem cells might regenerate in response to injury as part of the natural healing process. Dr, Schwob and his team tested this theory on mice and found that human stem cells regenerated in mice with injured nasal tissue. Perhaps more encouragingly, when they were transplanted into other mice, they were able to regenerate into different cell types.

Similarities can be seen between this study, and the Nobel Prize-winning approach developed by Dr. Shinya Yamanaka. Unlike Yamanaka, who induced cells taken from adult tissues to behave like embryonic stem cells by forcing them to express four genes, Schwob’s approach determined that only two of these four factors were critical to transforming the olfactory cells.

“The direct restoration of adult stem cells has implications for many types of tissue degeneration associated with aging, though we are several years away from designing actual therapies based on this work. The olfactory epithelium is a singularly powerful model for understanding how tissues regenerate or fail to do so,”

said Jim Schwob, M.D./Ph.D., a professor of Developmental, Molecular & Chemical Biology at Tufts University and senior author of the study.

If we can restore the population of stem cells in the olfactory epithelium by regenerating them or by administering the right drug as a nasal spray, we may be able to prevent deterioration in the sense of smell,” he continued.

Stem Cell Research Holds Possibilities for Diabetic Foot Ulcers

Scientists in Glasgow have made a breakthrough, which could make a big difference to sufferers of diabetes by helping to treat their foot ulcers.

Foot ulcers are a common side effect of diabetes caused by nerve and blood vessel damage. An estimated 15% of diabetes patients develop foot ulcers as a result of the condition.

The impact of foot ulcers can be severe – for some patients the severity of the ulcers eventually leads to amputation.

Hope for Treatment

This latest study carried out by researchers at the Glasgow Caledonian University has managed to reprogramme human cells using leftover skin tissue from surgery to replicate wounds from diabetic foot ulcers.

The team used donor skin tissue samples from people with type 2 diabetes. From these they created batches of human stem cells ready to be reprogrammed into different types of cells including brain and nerve cells. It is hoped that in the future these cells will be able to be used to repair tissue and skin damage resulting from foot ulcers, and hopefully prevent the need for amputation.

The research is part of a three-year project funded by Animal Free Research UK who is hoping to develop new treatments for foot ulcers that do not need to be tested on animals, as currently is the case.

Professor Ann Graham, lead author of the study said:

“Over 135 diabetes-related amputations are carried out each week in the UK. We know that this is a growing problem and we hope that our work can inform research and aid others who require access to human material for medical research.”

Future research by the team will examine the links between type 2 diabetes and Alzheimer’s disease, as well as diabetic wound healing and psoriasis.

Are stem cells the link between bacteria and cancer?

Is there A link between stem cells, bacteria and cancer?


Scientists have long believed that an increase in stem cell turnover plays a part in the development of cancer, and now new research has uncovered findings that could strengthen the link.

A study was carried out by the Max Planck Institute in Berlin in conjunction with researchers in Stanford, California, and examined the presence of bacteria and it’s impact on stem cell regeneration. The survival rate for stomach cancer is low, mainly because patients don’t present any symptoms until the cancer has reached an advanced stage. Stomach cancer, or gastric cancer, is caused by the bacterium Helicobacter pylori, which is naturally present in all humans. However, this bacteria acts differently to tumour viruses, leaving scientists in the dark as to how they actually cause cancer. The new research has revealed that this bacterium “sends stem cell renewal in the stomach into overdrive”, a discovery that could open doors to further understanding the cause and therefore treatment of stomach cancer.

About the research

The study confirmed that in the majority of cases, patients with most  stomach cancer experience chronic infections with H. pylori bacterium.

Prof. Dr. Thomas F. Meyer specialises in molecular biology, and worked alongside

fellow researchers at the Max Planck Institute for Infection Biology in Berlin. Having spent many years examining the impact H. pylori has on the stomach’s epithelium cells, the team were in search of answers as to why cancer was able to form in an environment in which cells are being replenished so rapidly. As stem cells are the longest living cells in the stomach, the researchers began their search for answers here. While it had previously been believed that H. pylori affected only the rapidly-replaced surface cells, but the research revealed that the bacteria managed to infiltrate the stem cells, causing them to rapidly multiply.

The team arrived at this conclusion following tracing the behaviour of two different types of stem cells in the stomach of mice. According to Science News Online:

Both respond to a signalling molecule called Wnt, which maintains stem cell turnover in many adult tissues. Crucially, they discovered that myofibroblast cells in the connective tissue layer directly underneath the glands produce a second stem cell driver signal, R-spondin, to which the two stem cell populations responded differently. It is this signal, which turned out to control the response to H. pylori: Following infection, the signal is ramped up, silencing the more slowly cycling stem cell population and putting the faster cycling stem cell population into overdrive.

According to one of the study authors and clinical scientist Michael Sigal, these results substantiate the theory that chronic bacterial infections are strongly linked with cases of stomach. “Our findings show that an infectious bacterium can increase stem cell turnover,” he says. “Since H. pylori causes lifelong infections, the constant increase in stem cell divisions may be enough to explain the increased risk of carcinogenesis observed.”

Regenerative Medicine Market projected to reach $5.5 Billion

According to analysis found in a new report, “Regenerative Medicine Market, 2014 – 2025”, the global regenerative medicine market size is expected to reach USD 5.59 billion in just eight years.

This high rate of growth is being attributed in part to the increased global geriatric age, with the World Health Organization now revealing the average life expectancy to be 71.4 years (2015). This is in addition to the increased prevalence of Neurodegenerative disorders, along with Orthopedic and other aging-related disorders. As biotechnology has advanced to seek treatments for these and other illnesses, this has lead to increased investment in the field. The biotechnology has so far enabled scientists to garner more in-depth knowledge of cell division, differentiation and mutation, as well as cell metabolism. According to a press release from Research and Markets, “this enriched knowledge, coupled with emergence of novel streams of biotechnology such as gene therapy and nanotechnology, further prospered use of cell-based technology in therapeutic treatment.”

Advancements have been made thanks to the identification of ways to use stem cells in regenerative medicine, according to the report. There has been increased coverage of such trials, and so many regenerative experts have looked to other potential fields for similar applications, such as induced pluripotent stem cells (iPSC). According to the report, the demand for global regenerative medicine exceeded USD 1.7 billion in 2016, a figure that is expected to rapidly rise over the coming years as this research has lead to a strong pipeline of potential products and treatments. The study reveals that in  2016, therapeutics emerged as the largest product segment in the market, owing to it’s high rate of usage and  implementation. Where global regenerative services are concerned, demand for facilities such as tissue banks and cellular engineering tools is “expected to drive demand in the segment”.

Another key finding in the report was the impact that the emergence of gene therapy techniques has had on the industry. This has been a major driver, as treatments “Regenerative medicine grabs the attention of the healthcare industry owing to its promising applications along with significant advances in supportive fields including tissue engineering, stem cells, gene therapy, drug discovery and nanotechnology,” reads a report summary. “For instance, 3D printing over scaffold with stem cells to restore structure as well as functional characteristics of biological cells, tissues, and organs.Biologics, individually or in combination with cells or devices, are explored to support regenerate the biological functions of cells, tissues, or organs. A number of combinatorial therapies to support chemotherapy and other cancer treatments by prevention as well as treatment for cancer relapse are in development phases. In addition, rising prevalence of complicated degenerative disorders such as age-related macular degeneration, Alzheimer’s disease, and Parkinson’s disease, especially in the aging population resulted in high investments in R&D to develop therapeutic solutions.”