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.

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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.

Researchers find new way to kill cancer stem cells

For the scientific community, looking for ways to combat cancer continues to be a challenge, albeit one that has experienced a number of breakthroughs in recent years and even months.

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Researchers in Penn State recently found that grape-based compounds can kill colon cancer stem cells, after conducting petri-dish trials and trials on mine. In Salford, Manchester, researchers found that a combination of vitamin C and antibiotics can knock out cancer stem cells. Now just last week, researchers in Canada’s McMaster University have identified a unique feature of cancer stem cells, which could potentially play a vital role in the development of more targeted cancer treatments.

How existing drugs can kill deadly cancer stem cells

In a study published in Cell Chemical Biology, research reveals that an existing series of drugs has proved effective in killing off cancer stem cells.

It is thought that these stem cells play in part in the recurrence of cancer following treatment, and so using these drugs may be able to help patients stay cancer free. These drugs are thought to be able to attack these cancer cells thanks to the presence of a protein called Sam68. According to Mick Bhatia, the study’s principal investigator and scientific director of the McMaster Stem Cell and Cancer Research Institute, the findings are helping the team uncover how stem cells function in cancerous human tumours. “The drugs helped us to understand the biology,” he writes. “We’ve worked backwards, employing a series of drugs used in the clinic to understand a new way that cancer stem cells can be killed.”

It is the hope of Bhatia that this breakthrough will enable those being treated for cancer to receive more targeted, relevant therapy. While patients undergoing treatment for breast cancer currently receive targeted treatments depending on the type of disease, therapies for cancers for example do not. “In the case of breast cancer, other researchers have found new ways to make existing drugs more effective by only giving them to people who were likely to benefit based on their specific traits and using drugs that target these traits,” said Bhatia.

Stem cells help recovery from prostate surgery

It is relatively common for men recovering from prostate surgery to experience erectile dysfunction during recovery. Research shows that up to 80% of men have difficulty having sex in the months following the operation.

erectile

A clinical trial is pointing to the possibility of stem cells being used to help treat erectile dysfunction in these cases.

In the first-phase of clinical trials, eight out of 15 men who were unable to have an erection after their prostate surgery, had sex six months after one-time treatment of stem cells.

The procedure involves removing fat cells from a patient’s abdomen via liposuction. After a specialised treatment, these are transformed into all-purpose stem cells.

The stem cells are then injected into the penis, where they begin to change in to nerve and muscle cells, as well as the endothelial cells that line blood vessels.

The 12 month follow up showed that the success of the treatment was ongoing.

 “As far as we know, this is the first time that a human study with a 12-month follow up shows that the treatment is lasting and safe,” said Lars Lund, a professor at Odense University hospital in Denmark.

 “That is much better than taking a pill every time you want to have intercourse,” he said.

The study has been so successful, that the next stage, a double- blind randomised trial has been approved. This study will include a placebo group

Only men recovering from prostate cancer and able to control their bladders will be enrolled in the new experiments, Lund explained.

US clinical study seeks to see if stem cells can cure baldness

Four American surgeons are the latest group of many worldwide who are attempting to see how stem cells could be used to combat baldness.

In the five-patient study lead by Kenneth Williams, D.O. of Orange County Hair Restoration, a clinical trial is taking place in which PRP and stem cells are being used in conjunction with each other to treat hair loss. Fat is removed from the abdomen before being emulsified to separate the stem cells. These cells are then mixed with the patient’s concentrated plasma before the mixed formula is injected into the scalp. Williams hopes the results of his study will be publishable in two years’ time. “The study is taking cells that are in our body that help to regenerate or stimulate inactive or dormant hair follicles,” he told news outlets. “That is the theory behind what we’re doing this procedure on.”

Overseas trials already showing promise

The American Hair Loss Association notes that two-thirds of men will experience some thinning by the age of 35, while by the age of 50, roughly 85 per cent will be affected by significant thinning.

It’s perhaps no wonder then that so many scientists around the world are searching for ways to utilise stem cells to cure the condition. Clinical trials in Japan for example are already making significant strides in research; Kyocera Corp and Organ Technologies are conducting regenerative medicine trials in attempts to develop a cure. Led by Takashi Tsuji, the research team has already had some success in regeneration using stem cells, using them to reinvigorate hair follicles in mice. Hormones can impact the natural cycle of hair follicle regeneration, which is powered by stem cells, as can damage caused via trauma. Taking tips from skin restoration, follicular regenerative medicine works by removing small patches of skin and hair follicles from scalp to extract active stem cells. These are then multiplied, processed, and transformed into follicles using what Tsuji has dubbed the primordium method. These transformed cells are then injected into the patient’s scalp. This process differs from current baldness cures as the hair follicles are actually regenerated, as opposed to treatments such as hair transplants, which simply move the hair from one place to another.

Given that approximately 18 million people suffer with hair loss in Japan, it’s not only Takashi Tsuji and his team who are on working on potential cures. Cosmetic giants Shiseido Co. have plans to release a cure for baldness throughout Japan and other countries in Asia as early as next year.

Could Stem Cells Be Used To Restore Vision?

The eye is one of the most structurally complex parts of the body. Different disorders of the eye develop when one or more of the components stop working. This is why it is so difficult to treat conditions of the eye, and reverse sight loss.

Stem cells may well hold the answer.  By replacing damaged cells with new, healthy, specialised cells, it could be possible to reverse the damage done and restore vision.

Currently the only clinically approved stem cell treatment for the eye is Holoclar®, a treatment which restores vision to patients with damaged corneas by transplanting limbal stem cells into areas where these cells are lacking.

Use in Macular Degeneration

One of the leading causes of vision loss is Macular Degeneration (MD), a painless, age-related eye condition, which causes the person to lose their central vision making vision blurry.

Stem cell therapy has been trialled to treat MD but has so far been unsuccessful due to the replacement cells struggling to integrate into the original tissue.

Researchers may have found a solution to this in the form of an injection of an  immune system protein- Mesencephalic Astrocyte-derived Neurotrophic Factor (MANF) – to assist with the integration.  Research carried out by the Buck Institute showed success in retinal stem cell transplants on congenitally blind mice, and human trials are the next step.

If the protein is successful in human therapy, it could be used to treat early-stage MD in the future.

MANF has previously been studied by other scientists, including  Ajan Rejinald, CEO of Celixir,  for its role in conditions like Parkinson’s disease