Stem Cell Clinic

FDA cracks down on clinics selling unapproved stem cell therapies – CBS News

By adminAugust 29, 2017Stem Cell Clinics

The U.S. Food and Drug Administration announced a crackdown on stem-cell clinics marketing and selling unapproved and potentially harmful therapies for cancer and other diseases.

The agency took action against two large clinics in Florida and California, which have started selling treatments that the agency says use stem cells but have not been approved as safe and effective by the FDA.

"A small number unscrupulous actors who have seized on the clinical promise of regenerative medicine, while exploiting the uncertainty, in order to make deceptive, and sometimes corrupt, assurances to patients based on unproven and, in some cases, dangerously dubious products," FDA Commissioner Scott Gottlieb, M.D., said in a statement.

The FDA issued a warning letterto US Stem Cell Clinic of Sunrise, Florida, after an inspection in which the agency found that the clinic was processing body fat into stem cells and administering the product both intravenously or directly into the spinal cord of patients with Parkinson's disease, amyotrophic lateral sclerosis (ALS), chronic obstructive pulmonary disease (COPD), heart disease and pulmonary fibrosis.

"The FDA has not reviewed or approved any biological products manufactured by US Stem Cell Clinic for any use," the agency said in a statement.

During the inspection, investigators also reported the clinic deviated from guidelines put in place to prevent microbiological contamination, which puts patients at risk for infections, the agency said.

Also this week, the FDA seized five vials of a smallpox vaccinefrom StemImmune Inc. in San Diego, California, which the agency said was used to create an unapproved treatment of stem cells and excess amounts of the vaccine, which was then administered to cancer patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, California.

The FDA says this treatment put patients at risk for potential harms including inflammation and swelling of the heart and surrounding tissues.

The agency said it will investigate how StemImmune Inc. obtained the vials of the vaccine, which each contained 100 doses. The vaccine is not commercially available and is reserved only for people considered at high risk for smallpox, such as some members of the military. One vial was partially used, while four of the vials were still intact, the FDA reports.

"I've directed the agency to vigorously investigate these kinds of unscrupulous clinics using the full range of our tools, be it regulatory enforcement or criminal investigations. Our actions today should also be a warning to others who may be doing similar harm, we will take action to ensure Americans are not put at unnecessary risk," Gottlieb said.

In response, Dr. Mark Berman, co-founder of the California Stem Cell Treatment Centers, told the Los Angeles Times that the comments from the FDA are "disparaging and misrepresentative," and said they showed "a lack of understanding" of surgical procedures in which patients' own stem cells are used to promote regeneration.

Berman, who is also director of stem cell implantation at StemImmune, called the clinic's products "cutting edge cancer therapy" for Stage 4 cancer patients, the Times reports.

US Stem Cell Clinicposted a response to its website, saying, "The safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws of the Food and Drug Administration."

"The FDA has stated that they will have specific stem cell guidelines by the 21st Century Cures Act deadline of December 13, 2017 and we intend to follow those standards as well," the statement continues. "We have helped thousands of patients harness their own healing potential. It would be a mistake to limit these therapies from patients who need them when we are adhering to top industry standards."

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FDA cracks down on clinics selling unapproved stem cell therapies - CBS News

FDA cracks on clinics using unapproved stem cell treatments – Pulse Headlines

By adminAugust 29, 2017Stem Cell Clinics

The U.S. Food and Drug Administration (FDA) said on Monday that it would take severe measures after it found that clinics around the country are selling unapproved and potentially dangerous stem cell treatments to patients with cancer and other hard diseases, according to a warning letter posted by the agency.

The crackdown was announced due to hundreds of clinics around the country selling unapproved stem cell therapies, but two of them were specifically pointed: the U.S. Stem Cell Clinic of Sunrise, Florida; and California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills. In the last one, certain doctors carried out a surgery where they injected a smallpox vaccine intravenously and directly to the patients tumors.

Many of these patients have suffered great harm, and even death as a result of using unproven stem cell therapies, the President of the International Society for Stem Cell Research, Hans Clevers, said in a statement. We are hopeful that increased regulatory enforcement against clinics offering unproven treatments will deter this practice and help protect patients.

On Monday, the FDA posted on its web page a warning letter sent last week to U.S. Stem Cell Clinic of Sunrise, Florida. In it, the agency condemned the selling of unapproved stem cells treatments, which doctors injected intravenously and directly into the patients spines. Previously, according to a report published by the New England Journal of Medicine, this Florida clinic was already linked with three women who ended up blind after they were subjected to a fat-stem cell treatment for macular degeneration.

However, this is just one of many other clinics around the country that the agency accused to use stem cells vaccines to treat different conditions, such as cancer, Parkinsons disease, amyotrophic lateral sclerosis (ALS), and lung and heart diseases.

Along with it, on the same Monday, the agency announced that last week it accused StemImmune Inc. of San Diego to purchase five live virus vaccine vials, previously designated to only those patients who were at high risk of smallpox. At the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, the vaccines were later combined with stem cells extracted from patients fat and injected directly to patients tumors.

Ive directed the FDA to launch a new working group to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health, The FDA commissioner, Dr. Scott Gottlieb wrote in a statement. We have examples where some of these unproven treatments have clearly harmed patients.

Doctors might offerunapproved stem cells therapies, and people under high-risk diseases might accept them without having a second thought. This is why the FDA published a series of advice for safe before they choose an unproved and dangerous treatment instead of a secure and adequate therapy.

If you see a business thats making all sorts of dramatic marketing claims across disease categories, claiming to use fat as a treatment for all sorts of indications, these are all signs to be wary of, said Leigh Turner, associate professor at the Center for Bioethics at the University of Minnesota.

According to Turner, it is not easy for patients to either recognize which treatment would be good and beneficial for them, or which one would be totally dangerous.

Source: CNN

Brain Dead Patients Could Be Brought ‘Back to Life’ in Groundbreaking Stem Cell Therapy – Wall Street Pit

By adminAugust 28, 2017Stem Cell Treatment

Brain Dead Patients Could Be Brought Back to Life in Groundbreaking Stem Cell Therapy

This is not about creating zombies-those so-called living (or walking) dead that are very popular and make a really great theme for TV shows and movies.

Even the Game of Thrones has its version of the living dead with them nasty creatures called White Walkers and Wights.

But then again, thats only science fiction, isnt it? Well, maybe not. In fact, this science-fiction plot could soon play out in real life. Read on.

Researchers from U.S.-based biotech company Bioquark are aimimg to resurrect patients who have been declared brain dead. Yep, you read it right. Resurrect, just like those stories in the Bible. Really bringing back people to life.

It goes without saying that this is really a serious matter. More importantly, Bioquarks small pilot study has been approved and gotten ethical permission by none other than the National Institutes of Health. The study would be an attempt to reawaken the clinically-dead brains of patients who have suffered serious brain injuries.

How will Bioquark do it?

Through stem cell therapy, which has been proven successful already in treating various diseases such as acquired ataxia, Alzheimers disease, Bells Palsy, cerebral atrophy, cirrhosis, optic nerve damage, osteoarthritis, and leukemia.

But, with brain-dead people, its going to be a real challenge since this condition according to medical experts is irreversible.

Brain death is different from a heart thats already stopped beating. A heart can still be revived and sustained by a ventilator or life-support system.

However, in the case of brain death, you cannot revive dead neurons with the help of a life-support machine even though it continues to pump oxygen to the body. The oxygen will get into the other organs like the heart, but it can no longer be utilized by the brain when the neurons are dead.

Neurons are the working units of the brain, specialized cells which are responsible for transmitting information to other nerve cells, gland cells, and muscles.They form networks or connections in the brain which number up to trillions.

A traumatic brain injury, sudden cardiac arrest, or a stroke caused by a ruptured blood vessel in the brain can cause brain tissues to start dying due to oxygen deprivation.

Oxygen-Deprived Brains Timeline:

However, Bioquark is hopeful that stem cell treatment may spur the growth of new neurons to replace the dead ones and pave the way to revive a clinically dead brain. After all, the brain is a fighter and scientists have found out that our gray matter has a small reservoir of stem cells which can produce new neurons.

Researchers are thinking of the possibility of urging these stem cells to generate new neurons which can remedy injured brain tissues. One other option is to inject neural stem cells into the brain of a person who has just died, and these may generate the necessary new neurons to help revive the brain.

Soon, Bioquark will find out the answer or learn some more information from their pilot study which is the first stage of the companys broaderReanima project. The project is exploring the potential of cutting edge biomedical technology for human neuro-regeneration and neuro-reanimation as a way to hopefully give patients and their loved ones a second chance in life.

Bioquark is set to conduct this very first human trial in partnership with the Indian biotech company Revita Life Sciences which specializes in stem cell treatment.

US FDA to remove unproven, potentially harmful treatment used in ‘stem cell’ centers – Times of India

By adminAugust 28, 2017Stem Cell Treatment

BRIEF-U.S. FDA to remove unproven, potentially harmful treatment:BRIEF-U.S. FDA to remove unproven, potentially harmful treatment used in 'stem cell' centers

Aug 28 (Reuters) - U.S. Food and Drug Administration

* says took action to prevent the use of a potentially dangerous and unproven treatment belonging to stemimmune

* Fda- on behalf of fda, on aug 25, u.s. Marshals service seized five vials of vaccinia virus vaccine (live)

* Fda - is actively investigating the circumstances by which stemimmune came to possess the vaccine

* Fda-As vaccinia virus vaccine is not commercially available, fda has "serious concerns" about how stemimmune got product for unapproved, potentially dangerous treatment

* Fda-Seizure comes after fda inspections at stemimmune, california stem cell treatment centers confirmed vaccine used to create an unapproved stem cell product

* Fda says u.s. Department of justice filed seizure complaint, on behalf of fda, in u.s. District court relating to stemimmune Source text for Eikon: (http://bit.ly/2wbFDHk)

(This story has not been edited by timesofindia.com and is autogenerated from a syndicated feed we subscribe to.)

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US FDA to remove unproven, potentially harmful treatment used in 'stem cell' centers - Times of India

FDA cracks down on stem-cell clinics, including one using smallpox vaccine in cancer patients – Washington Post

By adminAugust 28, 2017Uncategorized

The Food and Drug Administration on Monday announced a crackdown on stem-cell clinics offering unproven and potentially dangerous treatments, including an operation in California that the agency said was using the smallpox vaccine on seriously ill cancer patients.

U.S. marshals on Friday raided San Diego-based StemImmune and seized the vaccine, which the FDA said had been combined with fat-derived stem cells to create an unapproved product. The concoction was injected intravenously and directly into patients' tumors at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, the agency said.

FDA Commissioner Scott Gottlieb, in a statement on StemImmune, said the agency will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work.

In a separate enforcement action, the agency on Monday posted a warning letterissued last week to U.S. Stem Cell of Sunrise, Fla., saying thatrecent FDA inspections of the clinic found that it was using stem cells derived from fat to purportedly treat illnesses including Parkinson's disease, ALS and heart disease. The agency said it hasn't approved any of the clinic products for any use.

The clinic in March was the subject of a New England Journal of Medicine article that said that three women with age-related macular degeneration were blinded or had their vision badly impaired after undergoing procedures at the clinic. Stem cells were injected into their eyeballs.

Gottlieb, in a separate policy statementabout stem cell therapies, said that the emerging field of cell-based and so-called regenerative medicine holds significant promise for transformative and potentially curative treatments for serious illnesses but that a small number of unscrupulous actors is putting the field at risk.

While stepping up enforcement to weed out those clinics, he said, the agencywill develop a framework to more clearly describe the rules of the road for the field and to allow responsible developers of stem-cell treatments to more easily win FDA approval.

The FDA must advance an efficient and least burdensome framework as a way to help new products remain compliant with the law through a regulatory structure that does not become a barrier to beneficial new innovation, he said.

Stem-cell clinics offering unapproved and unproven treatments have sprung up by the hundreds across the country over the past several years. Many offer fat-derived injections that supposedly treat everything from hip and knee problems to autism and Alzheimer's disease.

In the case of the California clinic, the FDA said it had serious concerns about how StemImmune obtained the smallpox vaccine, which is not commercially available. The vaccine typically is reserved for people at high risk for smallpox, such as members of the military, it said.

The vaccine is made from a live virus called vaccinia, which is a poxvirus that is similar to smallpox but less harmful. The vaccine can't cause smallpox, but for people with compromised immune systems as is the case with many cancer patients exposure can result in life-threatening medical problems, including myocarditis, which is a swelling of the heart.

Three women blinded by unproven stem cell 'treatment' at South Florida clinic

Unregulated stem-cell clinics are proliferating across the United States

Stem-cell clinics face new scrutiny from federal regulators

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FDA cracks down on stem-cell clinics, including one using smallpox vaccine in cancer patients - Washington Post

6 arrested over unauthorized stem cell therapy using cord blood – Kyodo News Plus

By adminAugust 28, 2017Uncategorized

Police on Sunday arrested a doctor and five others suspected of involvement in unauthorized stem cell therapies using blood from umbilical cords and placenta after childbirth.

The doctor who heads a clinic in Tokyo and people involved in cord blood sales are suspected to have administered cord blood to seven patients to treat cancer and as a beauty treatment. Each treatment is said to have cost 3 million to 4 million yen ($27,400-$36,600).

While hopes are high over the use of cord blood in the field of regenerative medicine to treat a number of diseases as it contains stem cells, the health ministry is concerned over the spread of costly medical services provided without clear scientific evidence and without ensuring sufficient safety.

The arrests were the first of anyone suspected of violating a law on regenerative medicine that came into force in 2014. The transplantation of cells could involve the risk of graft rejection and infection.

Medical institutions using stem cells are required to submit treatment plans beforehand for review by the health ministry, except for treating designated diseases such as leukemia.

The six suspects allegedly conducted the treatments without notifying the authorities.

Those arrested include Shinsuke Shuto, a 40-year-old doctor in Tokyo, and Tsuneo Shinozaki, 52, who runs a Tsukuba, Ibaraki Prefecture company selling cord blood, and Shusuke Tsubo, 60, who runs a clinic in the city of Kyoto.

Shuto is among those who allegedly administered cord blood to four patients at his clinic between July last year and this April without reporting the treatment to the government. Shinozaki and Tsubo are suspected of involvement in the unauthorized treatment of three people from around February last year to April.

The police have not made clear how the six suspects have responded to the allegations.

The seven patients included one minor and others ranging in age from the 40s to 70s. Six lived in different prefectures in Japan and one was a Chinese, the police said.

According to the police investigation, Shinozaki's company was selling cord blood it took over from a private cord blood bank in Tsukuba, which went under in 2009. It had enough cord blood to treat more than 1,000 people.

Between May and June this year, the health ministry ordered a total of 12 clinics in Tokyo and other cities, including Shuto's clinic, to suspend treatment after they were found to have administered cord blood for cosmetic therapy or cancer treatments without notification. The effectiveness and safety of such therapy has not been proven.

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6 arrested over unauthorized stem cell therapy using cord blood - Kyodo News Plus

CSL snags a preclinical stem cell therapy in $416M Calimmune buyout, plans to spin out HIV effort – Endpoints News

By adminAugust 28, 2017Uncategorized

CSL Behring has bagged the stem cell gene therapy player Calimmune for $91 million and another $325 million in milestones for the years-long clinical journey ahead.

CSL is acquiring two therapeutic tech platforms in the deal, which involve developing and delivering stem cell therapies. CSLs main pipeline interest is in Calimmunes preclinical sickle cell disease and -thalassemia, which the buyer sees as a big plus for its work in hematology.

CSL, though, plans to let go of control of Calimmunes lead, clinical program on HIV as soon as possible. In a follow-up to a query, a company spokesperson replied:

We are currently evaluating our options for developing this pipeline candidate, which could include licensing or partnering. Given our areas of focus, it is unlikely that we will develop this candidate on our own.

Paul Perreault

CSLs plans to development the preclinical program acknowledges that this will be a lengthy process. In their statement CSL notes that it expects to take eight years to push through the clinical program.

Calimmune has research work underway in Australia and California, where the company has gained support for the California Institute for Regenerative Medicine.

Calimmune shares in our promise and focus to improve the lives of patients with rare and serious medical conditions, said CSL CEO Paul Perreault. The acquisition represents another important step in the execution of our strategy for sustainable growth.

Calimmune CEO Louis Breton added:We are excited to become part of CSL Behring. They are an established global industry leader in protein-replacement therapies and have a proven track record of driving innovations through the development pipeline and delivering differentiated products to the global marketplace. Together, we are well positioned to take our achievements to the next level.

Full-text daily reports for those who discover, develop, and market drugs. Join 17,000+ biopharma pros who read Endpoints News by email every day.

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CSL snags a preclinical stem cell therapy in $416M Calimmune buyout, plans to spin out HIV effort - Endpoints News

Researcher highlights dangers of administering cord blood – The Mainichi

By adminAugust 28, 2017Uncategorized

August 28, 2017 (Mainichi Japan)

A regenerative medicine researcher has slammed the unauthorized administration of umbilical cord blood to patients by clinics in Japan that has recently come to light.

"The regenerative medicine practice of administering other people's cord blood to people such as cancer patients is highly dangerous. The fact that this was not registered with the government is a major issue," the researcher says.

Cord blood is abundant in stem cells that can become numerous types of cells. Under the Act on the Safety of Regenerative Medicine that came into force in 2014, regenerative medicine was broken down into three categories -- depending on the level of risk -- taking into account factors such as the type of cell and medical practice.

The administration of cord blood to another person has been classified under the highest-risk category of "Class I regenerative medicine," on the basis that the medical practice of administering other people's cells into patients' bodies carries unknown risks. As a result, it has since become mandatory for doctors involved in this practice to notify the government about any plans to administer cord blood.

Osaka University Professor Yoshiki Sawa, chairman of the Japanese Society for Regenerative Medicine, points out that, "The efficacy of administering a person's cord blood to other people such as cancer patients has not been verified, and it's the same as fraud because you are exploiting any hope a patient may have. There is a risk of spreading infection by doing this act."

In the latest cases of unauthorized cord blood administration, which led to the arrest of six people, original source of the blood was found to be a private cord blood bank. Private banks store cord blood of for a fee, and the blood is used to treat children and their relatives. According to the Ministry of Health, Labor and Welfare, there are said to be at least two such places in Japan.

There have been concerns that failed banks might release cord blood into the market as they are not subject to government regulation. Generally speaking, private banks are supposed to discard any cord blood that has been kept beyond the stipulated storage period, unless it is provided for research purposes. However, according to one person connected to these banks, "There are no clear rules about how to handle cord blood that has been thrown away" -- recognizing the possibility for discarded samples to be resold.

Some specialists point out that the latest cases of clinics using unauthorized blood is just the tip of the iceberg, and that it is impossible to rule out other similar cases that cannot be determined under current legislation.

Dr. Toshio Miyata, a board member of the think tank Health and Global Policy Institute that is particularly knowledgeable on laws surrounding regenerative medicine, says, "In effect, private cord blood bank businesses can operate unchecked. There is a need to crack down on such places by imposing laws and regulations."

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Researcher highlights dangers of administering cord blood - The Mainichi

Chlitina Profile part I: Exploring the age of medical beauty – CosmeticsDesign-Asia.com

By adminAugust 28, 2017Uncategorized

By Natasha SpencerNatasha Spencer , 28-Aug-20172017-08-28T00:00:00Z Last updated on 28-Aug-2017 at 13:04 GMT2017-08-28T13:04:11Z

Chemist Dr. Chen Wugang is the founder of Taiwanese skin care and beauty salon franchise, with Joanna Chen now at the helm of Chlitina as the CEO. Ryan Chao, Chlitinas Chief Operating Officer for the Greater China area, talks about the latest developments in the beauty industry in China.

How did Chlitina and Dr. Chen Wugang first connect beauty and medicine?

Back in 1989, Dr. Chen Wugangs chemistry background enabled him to create skin care products that were better formulated, with a pH of 5,5 only which at the time was a small revolution.

Dr. Chen likes to recall that he was at first criticised for this choice but that later, dermatologists agreed with him that a 5,5 pH was the correct level for a skin care product.

Thirty years ago, numerous products in Taiwan were quite aggressive with very high pH levels, and as a result, many Taiwanese women complained of skin and hair scalp problems.

That is what prompted Dr. Chen to create products that would help women regain healthy skin with a fresh, rosy glow. This philosophy has been at the heart of the brand ever since.

How has this connection evolved since 1989?

Today, Chlitinas core business is as a skin care and beauty salon franchise. Customers are usually active women who seek luxurious cosmetics and who aspire to have a light complexion and well hydrated healthy skin.

In China, these two elements are absolute priorities. Most Chlitina products have a whitening effect as well as moisturising properties. Women above 40 also worry about wrinkles and skin sagginess, so a big portion of Chlitinas portfolio is devoted to attenuating the signs of ageing.

Recently, Chlitina has started looking into medical beauty by opening its first plastic surgery clinic in collaboration with Chinese surgeons, specialising in light procedures. Chlitina is very careful to abide by Chinas stringent regulations in every aspect of its development and this is especially true for its medical venture.

What prompted Chlitina's push towards creating a regenerative medicine platform with Tongii University?

Chlitina has actually long entertained a close relationship with Tongji University as our chairwoman Joanna Chen serves as a board director.

It is in this context that the idea of teaming up on regenerative medicine with researchers from Tongji University came up. The obvious priority is to have solid scientific backing and get an early start in a very promising field of medical research.

What are today's consumers seeking from skin care and how does this partnership help to serve this?

The notion of regenerative medicine is getting more and more appealing as science advances towards efficient and precise treatments using less controversial techniques than in the early years. For instance, the source of stem cells now is increasingly fat tissue collected directly from the patient.

On June 25th 2017, on the occasion of Chlitinas 20th anniversary in China, a researcher from Tongji University gave a brief lecture on the teams work and how it is going to change the way we think about ageing.

Their goal is to use mesenchymal stem cells (MST) MST can differentiate into many different kinds of cells, according to where they are transplanted to wipe out wrinkles and treat inflammatory skin diseases, by transplanting them into the patients body where needed.

Chlitina believes that regenerative medicine has enormous potential for growth and that in the long run, the company will be able to tap into this market by using its already well-established network of beauty salons to identify potential customers.

Even without talking about complex medical procedures involving cell transplants, which might take some time to put in place, the hope is that the research being done now may soon help formulate more efficient skin care products.

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Chlitina Profile part I: Exploring the age of medical beauty - CosmeticsDesign-Asia.com

5 ways 3D printing could totally change medicine – Futurity: Research News

By adminAugust 28, 2017Uncategorized

A new study aims to alert medical professionals to the potential of 3D printings future use in the field.

3D printing technology is going to transform medicine, whether it is patient-specific surgical models, custom-made prosthetics, personalized on-demand medicines, or even 3D printed human tissue, says Jason Chuen, Director of Vascular Surgery at Austin Health and a Clinical Fellow at the University of Melbourne.

Before inserting and expanding a pen-sized stent into someones aorta, the hose-like artery that carries our blood away from the heart, Chuen, a surgeon, likes to practice on the patient first. Not for real of course, but in plastic.

He has a 3D printer in his office and brightly colored plastic aortas line his window sill at the Austin Hospital in Melbourne. They are all modeled from real patients and printed out from CT scans, ultrasounds, and x-rays.

By using the model I can more easily assess that the stent is the right size and bends in exactly the right way when I deploy it, says Chuen.

At the moment 3D printing is at the cutting edge of medical research, but in the future the technology will be taken for granted by all of us in healthcare, he says.

At its core 3D printing is the use of computer guidance technology to create 3D objects from digital plans by applying layers of material, such as heated plastic, or powders in the case of metals and ceramics. It is being used to print out anything from toys and food, to warships producing on-demand spare parts and even drones. Medicine is just another frontier.

The new paper, coauthored by Chuen and Jasamine Coles-Black, from the Austin Hospital in Melbourne, appears in the Medical Journal of Australia.

Here are the top five areas in which 3D printing is set to change medicine, according to the Chuen and Coles-Black:

It sounds like something out of Frankenstein, but could we eventually 3D print human organs? Not exactly, says Chuen. But hes convinced that in the future we will be able to 3D print human tissue structures that can perform the basic functions of an organ, replacing the need for some transplants.

Scientists are already using 3D printing to build organoids that mimic organs at a tiny scale and can be used for research. They are built using stem cells that can be stimulated to grow into the functional unit of a particular organ, such as a liver or kidney. The challenge he says is to scale up organoids into a structure that could boost a failing organ inside a patient.

we are moving towards a world where if you can imagine it, you will be able to print it

Such bioprinting involves using a computer-guided pipette that takes up cell cultures suspended in nutrient rich solution and prints them out in layers suspended in a gel. Without the gel the cells would simply become a watery mess.

The problem, says Chuen, is that once inside the gel, cells can die in a matter of minutes. This isnt a problem for small structures like organoids that can be built quickly and then transferred back into a nutrient solution. But it is a problem when attempting to make something larger like an organ because the initial layers of cells will die before the organ is completed.

Unless there is some breakthrough that enables us to keep the cells alive while we print them, then I think printing a full human organ will remain impossible. But where there is potential is in working out how to reliably build organoids or components that we could then bind together to make them function like an organ, says Chuen.

People suffering from a range of ailments, such as the elderly, are often dependent on taking multiple pills throughout the day. But imagine if one pill could replace the ten pills your doctor has prescribed?

According to Chuen, 3D printing is on the way to making this possible, opening up a whole new world of customized medicines.

Rather than simply embedding a single drug in a pill that is designed to dissolve and release the drug at a set time, the precision of 3D printing means pills can be designed to house several drugs, all with different release times. A 3D printed polypill that contains three different drugs has already been developed for patients with diabetes and hypertension.

It maybe that in the future instead of a prescription your doctor will be giving you a digital file of printing instructions.

Studies of surgeons using 3D printed models to rehearse procedures have shown that operations can be completed faster and with less trauma for patients. The potential cost savings alone are considerable. As Chuenpoints out, running an operating theatre can cost AUD$2,000 an hour. That is over AUD$30 a minute.

Chuen and Coles-Black themselves have begun printing out copies of patient kidneys to help surgeons at the Austin in planning the removal of kidney tumors. Such hard plastic models can be made more realistic by printing them in more expensive flexible material such as thermoplastic polyurethane. The material cost of the hard plastic aortas in Chuens office is about AUD$15 (less than $12 in the United States), whereas if printed in soft plastic the cost can rise to AUD$50 (less than $40 USD).

The real cost in 3D printing biological models is not just materials or printers, but also the software used to translate the scans into files for the printer. The 3D segmentation software Chuen uses costs about AUD$20,000 a year (under $16,000 USD).

As soon as 3D printing began to take off people were quick to see the opportunity for creating amateur prosthetics for their petsfrom puppies to geese, and even tortoises. Unlike for humans, there was no mass-supply chain of prosthetics for pets. But mass-supplied prosthetics are likely to be a thing of the past as 3D printing is increasingly used to manufacture prosthetics that are exactly tailored to a patients needs.

For example, with hip replacements, surgeons have to cut and ream a patients bone to fit the prosthetic, but in the future, it will be normal to 3D print a prosthetic to fit a patient, says Chuen.

Just as 3D printing is allowing customized production of medicines and devices, the production itself is likely to become localized. The warehouses that are full of packaged medicines and prosthetics will in the future likely be replaced by digital files of designs that hospitals and pharmacies will be able to download and print on demand using stored raw materials, says Chuen.

Such distributed manufacturing, he says, could make medicines and devices more equitably available across the world so long as a local hospital for instance has the printing technology in place and access to raw materials.

However, Chuen warns distributed production will present new risks for ensuring the quality control of end products. It will need a fundamental shift in responsibility from the supplier to wherever the medicines or devices are manufactured. That represents a huge shift and we have to work out how it could work. But if we get the regulation right then it will transform access to medical products.

But for Chuen, the immediate overall challenge in medical 3D printing is ensuring that medical professionals themselves are up to speed with the technology because it is their clinical experience that will be needed to drive its successful application.

It is a revolutionary technology that will make medical care better and faster, and more personalized. But what we need is for more medical professionals to start exploring and experimenting with what this new technology can do, because many things that we thought of as impossible are now becoming possible.

I think we are moving towards a world where if you can imagine it, you will be able to print itso we need to start imagining, Chuen says.

Source: University of Melbourne

Original Study DOI: 10.5694/mja16.01073

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5 ways 3D printing could totally change medicine - Futurity: Research News