3D printed tissues for ear, skin and blood vessels are in clinical trials and research for other organs is underway too. We ask some bioprinting companies if and when humans can benefit from this technology.

Scientists and researchers across the globe are working hard to bioprint functional human organs to meet the demand of a growing list of people waiting for organ transplants across the world.

There are currently more than 106,000 people waiting for an organ transplant in the United States alone, with a new person added every 9 minutes to the list. 

Many of these people are in need of critical organs such as kidneys, hearts and livers that could save their lives. However, due to limited resources, around 8,000 Americans on the waiting list die each year.

Biotechnology company Regemat 3D believes the development of bioengineered organs for human transplants is an attainable goal and that 3D bioprinting will have a main role in that accomplishment.

“We believe 3D bioprinting is and will be a key factor in the progress towards more efficient and personalised medical treatments in the upcoming future,” Sara Mico, Regemat 3D’s Business Developer and Product Specialist, told TRT World.

Since 2015, Regemat 3D has grown to become one of the top 15 3D bioprinting emerging companies worldwide, with a presence in nearly 30 countries.

“We are the only company in the world specialised in the design and development of customised 3D bioprinters and bioreactors for tissue engineering applications,” said Mico.

Some benefits of 3D bioprinting cited by Mico include the potential to accelerate the development of new drugs and shorten the time required for them to reach the market and reduce the number of animals used in research.

But how far off is the expansion of this technology to creating complex organs?

Bioprinting company nScrypt predicts this reality will emerge within the next decade, Marketing/Sales and Communications Specialist Brandon B. Dickerson told TRT World.

“We all have our crystal balls, and I say 5 to 10 years. I think soon, I’ll be saying 4 to 8 years, we are closing the gap,” said Dickerson.

In contrast, Fabien Guillemot, CEO of next-generation bioprinting company Poietis, told TRT World it’s “difficult to define when (and if) the world will be able to print organs” due to the different degree of tissue complexity compared to that of organs.

“Different 3D bioprinted tissues are entering into clinical trials (ear, skin, blood vessels). Other applications like heart patches, cornea, cartilage are also in preclinical development in many institutions and companies, worldwide.”

Guillemot said all these trials contain tissues that have a different degree of complexity, which remains lower than that of an organ's, for example some are flat tissues and some include one or two different cell types.

“But, implanting bioprinted functional tissues might be sufficient to restore and repair organ functions without changing the whole organ,” said Guillemot. “So, we anticipate that clinicians will use in routine bioprinting and bioprinted tissue products made of the patient’s own cells.”

Mico said that while the field is still “very far” from the reality of bioprinting complex organs “it is so important to invest time and resources in basic and translational research today, because today’s research will become the clinical applications of tomorrow.”

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From research to clinical trials

While bioprinting was initially proposed around two decades ago, its first applications have been for research and testing such as in cosmetics and pharmaceuticals, Guillemot told TRT World.

Then in 1999, a functioning human bladder was the first artificial organ made using bioprinting by scientists at the Wake Forest Institute for Regenerative Medicine.

However, to be able to start a clinical trial was challenging as companies needed “to develop a bioprinter compliant with the regulations and to develop a tissue fabrication process leveraging this bioprinter,” Guillemot explained.

Fast forward 23 years and this was achieved by 3DBioTherapeutics. A 20-year-old woman born with a rare congenital deformity in her right ear became the first person to receive a 3D-printed ear implant made from her own living cells.

The medical breakthrough made headlines this month after the New York-based medical company took a sample of cartilage cells from the patient’s ear and grew them in a lab to create an implant.

The human cells were mixed with a collagen-based bio-ink before being inserted into a 3D bioprinter, which layer-by-layer created a mirror replica of the patient’s left ear, the company’s chief scientific officer, Nathaniel Bachrach, told the New York Times.

The company’s AuriNovo implant technology is currently being used in a clinical trial to help patients with microtia, a condition where one or both outer ears are absent or underdeveloped. 

CEO and co-founder of 3DBioTherapeutics Dr. Daniel Cohen called the transplant a “truly historic moment for patients with microtia,” a condition that affects around 1,500 babies in the US each year.

“And more broadly for the regenerative medicine field as we are beginning to demonstrate the real-world application of next-generation tissue engineering technology,” said Cohen.

Cohen hopes AuriNovo will become “the standard-of-care” as it is less invasive than current surgical methods for ear reconstruction that use rib cartilage.

Guillemot said that the success by 3DBioTherapeutics “shows that bioprinting is coming of age for therapeutic applications” and “can provide new solutions for patients and clinicians.”

“Being one of the few bioprinting companies engaged in the development of therapeutic applications, we (Poietis) are very enthusiastic by this news,” Guillemot said.

He said that his company plans to also start the clinical trial of its first bioprinted product Poieskin, a skin substitute, in the coming months.

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Bioprinting in space

But the bioprinting process comes with challenges – a lot of which comes “from biomaterial availability,” Micro explains.

“We carry out our own internal research – such as the development of a conductive bioink for peripheral nerve and spinal cord regeneration – and we identify promising biomaterials and help the research groups who developed them to bring them out into the market,” said Micro.

Other main challenges of bioprinting are related to the standardisation of tissue manufacturing process and the capacity to print more complex tissues in a way which is compatible with clinician routines and hospital constraints, according to Guillemot.

His company Poietis is addressing these challenges by developing next-generation bioprinters "which are robotised, multimodal and provide high-resolution. "

One of Poietis’s bioprinter has been installed in the Cell Therapy Center of Marseille Hospitals, as the company plans to equip cell therapy centers in hospitals “to enable them to develop and produce new applications for patients.”

“Installing bioprinters directly into hospitals, at the point of care, can reduce high costs and logistics challenges that you meet when you transfer living cells and tissues from the "factory" to the bedside,” said Guillemot.

In addition, bioprinting research is not just limited to laboratories and hospitals on Earth. Researchers at nScrypt in collaboration with Redwire’s Techshot are working on printing methods in microgravity, with the goal of eventually taking bioprinting capabilities to space.

“The first set of printing experiments is to print cardiovascular cells in microgravity to study any effects microgravity might have on printed cells,” Dickerson told TRT World. 

“The bioprinter is set up to print a range of materials to include cellular and acellular materials. The intent is to allow a diverse group of scientists that want to print in microgravity this capability,” he added.

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Aftermath of bioprinting

Another challenge faced by nScrypt’s teams and bioengineers as a whole is the aftermath of bioprinting and avoiding necrosis.

“Necrosis is the enemy, this means cells die and this occurs for many reasons, but just as your entire body needs food, oxygen and then to remove carbon dioxide and waste, so must cells and tissue,” said Dickerson explaining the importance of a vascular network for the bioprinted organs.

Companies are growing great vascularised tissue, but using thicker tissue in organs, makes it more challenging to move oxygen in and carbon dioxide out. 

“Bioprinting is important, but the incubation and feeding part is where the magic happens.  There is no such thing and there will be no such thing as printing an organ,” Dickerson said, adding when this is achieved then the organ growing potential will begin moving more rapidly.  

Aside from organ transplants, manufacturing artificial organs with 3D printing has the potential to help several sectors in the medicine field, such as in pharmaceutical research and the training of surgeons.

Using a patient’s own cells to create the 3D printed organs also greatly reduces the risk of donor organs being rejected by the body. But as experts point out, the finances of bioprinting remain another obstacle.

“The near future of bioprinting is discovery and experimental. We talk about a big game, but we still have quite a bit in front of us,” said Dickerson. “(This) will not happen if there is not a good business model.”

“This means money. This must make money. It is easy to make the business case, ‘how much are you willing to pay for a kidney or a heart?’ It is a cruel reality, but a reality nonetheless. But before we get to that, we must ask, how much are you willing to spend to learn how to do it?”

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Source: TRT World