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Posts Tagged ‘3-D bioprinting’


3-D Printed Organs

Curator: Larry H. Bernstein, MD, FCAP

 

 

 

The Future of 3-D Printing in Medicine

Today’s 3-D printed plastic models of hearts may one day translate into on-demand printed, functional replacement organs
http://www.dicardiology.com/article/future-3-d-printing-medicine?eid=333021707&bid=1408765#sthash.M7AYV16i.dpuf

http://www.dicardiology.com/sites/daic/files/styles/content_feed_large_new/public/field/image/3-D%20printed%20blood%20vessel%20like%20tube%20made%20of%20living%20cells.jpg

A 3-D printed vessel-like lumen made from living cells as part of the research at The South Carolina Project for Organ Biofabrication.

Science fiction offers a lot of ideas for creating new body parts on demand, and the advancement of 3-D printing (also called additive manufacturing) is slowly translating this idea into science fact. Today, the 3-D printed anatomic models created from patient computed tomography (CT), magnetic resonance imaging (MRI) or 3-D ultrasound imaging datasets are used for education and to plan and navigate complex procedures. These models are used to teach about complex or rare cardiac or congenital conditions that up until recently could only be seen using examples extracted from cadavers. Today, anatomical models of rare cardiac anatomy can be printed on demand from CT scans of surviving patients.  That concept can now be translated into 3-D printing of implantable devices customized to a specific patient using their imaging. Experts at several medical conferences are also saying printing functional biological replacement tissues is already in development.

Video interview with Dee Dee Wang, M.D., FACC, FASE, Henry Ford Hospital, explaining the use of 3-D printing to aid procedural planning and guidance in complex structural heart cases.

See video examples of 3-D printed hearts as part of the editor’s choice of the most innovative new teachnology at ACC.16. – See more at: http://www.dicardiology.com/article/future-3-d-printing-medicine?eid=333021707&bid=1408765#sthash.M7AYV16i.dpuf

Early Experience Printing Implantable Devices Printed 3-D models are currently used for surgical planning in complex cases, especially in pediatric congenital heart procedures, said Richard G. Ohye, M.D., professor of cardiac surgery, head, section of pediatric cardiovascular surgery, surgical director, pediatric cardiovascular transplant program, co-director, Michigan Congenital Heart Center, C.S. Mott Children’s Hospital, Ann Arbor, Mich. However, he explained 3-D printing will soon allow the creation of customized implantable medical devices, including actual tissue or vessel replacements.  In fact, 3-D printed devices are already being used on a small scale.

He presented a case of a three-month-old patient whose airway was underdeveloped and required a splint to hold it open. The patient underwent a CT scan and a 3-D reconstruction of the airway allowed doctors to create a virtual airway splint implant customized to fit into the small anatomy. The design included a “C”-shaped tube that had numerous holes to use as suture anchor points. The shape was designed to allow it to expand outward as the patient grew. They then 3-D printed the splint from bioresorbable plastic and implanted it in the patient. He said the material it was made from is expected to dissolve within three to four years.

The Finnish dental equipment maker Planmeca recently introduced a 3-D printer that allows dental laboratories and large clinics to create dental splints, models and surgical guides. In the near future, the Planmeca Creo printer will also support the creation of intricate, customized temporary fillings. The jump to printing full organs to transplant is much more complex, but the groundwork is being laid today. Ohye said engineered heart tissue created using cardiac stem cells has already been created, but it is limited to a size of about 200 microns. Anything larger requires blood vessels to keep the cells alive, he explained.

3-D Printing of Biological Tissue Implants Research is being conducted to enable 3-D printing of blood vessels, where cells are deposited by the robotically driven printer in patterns that build up layer-by-layer to create a lumen. That same concept is being tested at a few centers to create 3-D print heart valves. Ohye said the process currently being investigated used a printed matrix of biocompatible material, in which stem cells can then be deposited. If the process can be worked out to create engineered, printed organs, these might be used to create benchtop model organs for new drug testing in the next few years. Implantable 3-D printed living organs for transplant into human patients are also a very real possibility.

“Bioprinting is likely to be a huge field for the future of medicine,” said Roger Markwald, Ph.D., director, Cardiovascular Developmental Biology Center, Medical University of South Carolina. He is involved with The South Carolina Project for Organ Biofabrication, one of the groups at the forefront of 3-D bioprinting research. He explained there are too few organ donors to meet demand and there is an even greater need for soft tissues for reconstructive surgeries for things such as injuries, burns, infections, tumor resections and congenital malformations.  “There are too few organ donors to meet the needs,” Markwald said. “At least 21 people die each day because of the lack of implants.”  This organ shortage might be solved in the future by bioprinting organs on demand.

Biomaterials can be printed using current technology, but there is a fatal flaw. “The Achilles heel of tissue engineering today is the need to create vascularity in the structure, and that has been the focus of what we have been trying to do,” Markwald said.   The key to printing vascularizable micro-organs may involve chemical modifications of alginate hydrogels. Markwald’s lab created an oxidized alginate, which is biodegradable and provides stability for 3-D bioprinting. It also is bioactive, allowing cells to migrate and remodel. They created “plug and play” molds to prepare micro-organ constructs for surgical implantation. These are made with the biodegradable alginate, which contain small molecules to promote host vascular in-growth and suppress inflammatory responses.

Bioprinting is enabled using a “biopaper” made of bioresorbable hydrogels. These allow printing of the cells against gravity and allow the cells to grow, interact and function physiologically. Markwald said research is leading to the development of hydrogels specific to each type of organ tissue.  The “bioink” is made from 300 micron diameter spheroids that contain between 8,000-12,000 autologous adipose-derived stem cells. He said it takes about 7 million cells to make 840 spheroids, and it takes thousands of these spheroids to print a 1 mm cube.

Just as 3-D printing allows simultaneous printing of several different colors of materials to build a color 3-D model, bioprinting is being developed to allow use of several different cell types to create complex tissue units.  “Eventually we will be able to make functional hearts or livers,” Markwald said. “What we can print right now are cardiac patches and small- to medium-sized blood vessels, skin tissue, soft tissue (adipose, muscle) for reconstructive surgery, and vascularized micro-organs that can be grown in a bioreactor and used to supplement the function of a diseased organ like the liver.”

Creating 3-D Printable Files Creating files for 3-D printing from medical imaging datasets starts with good imaging, said Shuai Leng, Ph.D., associate professor of medical physics, Mayo Clinic, Rochester, Minn. “If you start with garbage in, you get garbage out, so you need good image quality,” he stressed.   To create a usable 3-D file, he suggests using 0.6 mm thin imaging slices. This allows for very smooth surfaces. By comparison, he said use of 6 mm slices will make the printed object very rough and textured, appearing pixelated, when it is printed in 3-D.  He said dual-energy CT is great for 3-D printing because it can easily exclude bone so only blood vessels or soft tissue remain in the image area.

Metal implants commonly cause problems when creating 3-D printing files, but dual-energy systems have metal artifact reduction software to separate the metal and artifacts from the anatomy to allow creation of better models.  When using 3-D models for procedural planning and navigation, you need to ensure the precision of the model by using U.S. Food and Drug Administration (FDA)-cleared 3-D printing software, such as programs offered by Stratasys or Materialise. The resulting printed models also should be compared to the original images to ensure quality control. Before printing, images should be checked in three planes and approved by a radiologist or the ordering physician.  The final imaging files are converted into STL/CAD files that can be read by the 3-D printers and translated into the final 3-D object.

Legal Considerations Regarding 3-D printing The field of 3-D printing comes with a new set of legal questions hospitals using the technology will need to consider, said Bruce Kline, a technology licensing manager who oversees patents for new technology developed at Mayo Clinic. For starters, he said the STL files printers use are a lot like MP3 music files, in that they can be protected under copyright and require licensing to use. Copyright violations can occur if a purchased STL anatomical model file for rare disease is illegally shared with another institution that did not purchase the file from the vendor that created the file. Under the law, if a device has a functional use it falls under patent law. If it is not functional, it falls under copyright law. Kline said most medical 3-D printing for educational models and complex anatomy evaluation currently falls under copyright. But, he said that will rapidly change in the coming years as customizable 3-D printable medical devices see wider use. Additive manufacturing allows the creation of patient-specific devices at the point of care. Kline said an interesting fact is that these devices are FDA 510(k)-exempt if produced by a hospital instead of a medical device vendor. He said this blurs the lines between traditional vendor relationships, since the hospital can now become the manufacturer. However, if a hospital makes a device, it also becomes liable for it.

He advised that it might be better for a commercial vendor to make the device for the hospital so the vendor assumes the liability of the device.   Custom-made medical devices are also exempt under FDA regulations, Kline said. So, if a physician creates or modifies a device to meet the clinical needs of a specific patient’s anatomy, he said it is acceptable to use under current FDA rules. This may leave the door wide open for use of 3-D printed devices that are customized for each patient using their own 3-D imaging datasets.  It is possible printable device files may become available in the next few years to customize and print on demand. However, Kline said it will be much more difficult to enforce patents on these types of devices. He explained if someone makes one or two devices, there is no economical way for the creator of those device files to go after the user/maker of unlicensed copies of the device to claim lost profits. Currently, Kline said surgical planning models created with 3-D printing are not reimbursable. No CPT code exists for their use, because he said CPT codes are based on clinical trial data showing clinical efficacy to justify reimbursement.

Proposed FDA Guidance for 3-D Printing   In May, the FDA released the draft guidance “Technical Considerations for Additive Manufactured Devices,” for public comment. It is a leapfrog guidance document to provide FDA’s initial thoughts on technical considerations specific to 3-D printed devices. Specifically, this draft guidance outlines technical considerations associated with additive manufacturing processes, and the testing and characterization for final finished devices fabricated using 3-D printing. It is intended to serve as a mechanism by which the agency can share initial thoughts regarding the content of premarket submissions for emerging technologies and new clinical applications that are likely to be of public health importance very early in product development. The draft document was created following a fall 2014 workshop where 3-D printing experts discussed all the facets of 3-D printing and attempted to anticipate the issues and questions that will be raised as 3-D printable devices begin to come before the FDA for review in the coming years. 

The FDA notes that in medical device applications, 3-D printing has the advantage of facilitating the creation of anatomically matched devices and surgical instrumentation by using a patient’s own medical imaging. The FDA said another advantage is the ease in fabricating complex geometric structures, allowing the creation of engineered open lattice structures, tortuous internal channels and internal support structures that would not be easily made or possible using traditional manufacturing approaches.  However, the FDA stated the unique aspects of the printing process, such as the layer-wise fabrication and the relative lack of history of medical devices manufactured using 3-D printing techniques, pose challenges in determining optimal characterization and assessment methods for the final finished device. There are also questions as to the optimal process validation and verification methods for these devices. The FDA is gathering public feedback on the draft document through August, 2016. The draft document can be found online at www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm499809.pdf

Partnerships Make 3-D More Accessible The setup and maintenance costs for 3-D printing are more involved than many hospitals want to get involved with. This is especially true at centers where there is very limited application. This has led to partnerships between advanced imaging vendors and 3-D printer vendors to create contract services for one-off printing projects.  Advanced visualization software company Vital Images announced a partnership with 3-D printer company Stratasys at the Radiological Society of North America (RSNA) 2015 annual meeting. They created the industry’s first print-on-demand service using Vital’s Vitrea advanced visualization software and Stratasys’ 3-D printing services. Vital Images’ software takes patient scans and converts them into STL files that can be sent directly to a 3-D printer, improving workflow efficiency and 3-D printing accessibility.

GE Healthcare is working with 3-D printer vendor Materialise to develop a software package that will allow the easy creation of 3-D printable files from GE 3-D ultrasound sound systems. GE hopes to have commercial product launch for this technology later in 2016.  Materialise already offers its Mimics Innovation Suite software to create 3-D printer files from medical imaging. Its latest version includes the ability to create images not only from MRI and CT datasets, but also from fluoroscopic imaging from C-arms. It also includes a virtual X-ray tool to allow engineers to create projects to find the optimal angle for 2-D/3-D registration. This allows for an evaluation of the 3-D position of bones and implants without a post-operative CT or MRI scan. It has an automated heart segmentation tool to easily separate the cardiovascular anatomy for advanced research and analyses. The vendor said on a good quality dataset, segmentation now requires only a few mouse clicks rather than several hours of tedious work.

Editor’s Choice of the Most Innovative Trends and Technologies ACC.16 – See more at: http://www.dicardiology.com/article/future-3-d-printing-medicine?eid=333021707&bid=1408765#sthash.M7AYV16i.dpuf

Stratasys to Present Power of 3-D Printing at HIMSS 2016 – See more at: http://www.dicardiology.com/article/future-3-d-printing-medicine?eid=333021707&bid=1408765#sthash.M7AYV16i.dpuf

 

Selecting the Right Material for 3D Printing

This industrial 3D printing white paper explores the properties of thermoplastic and metal materials available with direct metal laser sintering, selective laser sintering and stereolithography technologies. It also includes a quick-reference guide of material attributes that can steer you toward the proper grade.

http://whitepapers.ecnmag.com/20160517_proto_3d

http://www.ecnmag.com/sites/ecnmag.com/files/3D-Printing-Materials-WP-US-Final.pdf

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Update on FDA Policy Regarding 3D Bioprinted Material

Curator: Stephen J. Williams, Ph.D.

Last year (2015) in late October the FDA met to finalize a year long process of drafting guidances for bioprinting human tissue and/or medical devices such as orthopedic devices.  This importance of the development of these draft guidances was highlighted in a series of articles below, namely that

  • there were no standards as a manufacturing process
  • use of human tissues and materials could have certain unforseen adverse events associated with the bioprinting process

In the last section of this post a recent presentation by the FDA is given as well as an excellent  pdf here BioprintingGwinnfinal written by a student at University of Kentucky James Gwinn on regulatory concerns of bioprinting.

Bio-Printing Could Be Banned Or Regulated In Two Years

3D Printing News January 30, 2014 No Comments 3dprinterplans

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Cross-section of multi-cellular bioprinted human liver tissue Credit: organovo.com

Bio-printing has been touted as the pinnacle of additive manufacturing and medical science, but what if it might be shut down before it splashes onto the medical scene. Research firm, Gartner Inc believes that the rapid development of bio-printing will spark calls to ban the technology for human and non-human tissue within two years.

A report released by Gartner predicts that the time is drawing near when 3D-bioprinted human organs will be readily available, causing widespread debate. They use an example of 3D printed liver tissue by a San Diego-based company named Organovo.

“At one university, they’re actually using cells from human and non-human organs,” said Pete Basiliere, a Gartner Research Director. “In this example, there was human amniotic fluid, canine smooth muscle cells, and bovine cells all being used. Some may feel those constructs are of concern.”

Bio-printing 

Bio-printing uses extruder needles or inkjet-like printers to lay down rows of living cells. Major challenges still face the technology, such as creating vascular structures to support tissue with oxygen and nutrients. Additionally, creating the connective tissue or scaffolding-like structures to support functional tissue is still a barrier that bio-printing will have to overcome.

Organovo has worked around a number of issues and they hope to print a fully functioning liver for pharmaceutical industry by the end of this year.  “We have achieved thicknesses of greater than 500 microns, and have maintained liver tissue in a fully functional state with native phenotypic behavior for at least 40 days,” said Mike Renard, Organovo’s executive vice president of commercial operations.

clinical trails and testing of organs could take over a decade in the U.S. This is because of the strict rules the U.S. Food and Drug Administration (FDA) places on any new technology. Bio-printing research could outplace regulatory agencies ability to keep up.

“What’s going to happen, in some respects, is the research going on worldwide is outpacing regulatory agencies ability to keep up,” Basiliere said. “3D bio-printing facilities with the ability to print human organs and tissue will advance far faster than general understanding and acceptance of the ramifications of this technology.”

Other companies have been successful with bio-printing as well. Munich-based EnvisionTEC is already selling a printer called a Bioplotter that sells for $188,000 and can print 3D pieces of human tissue. China’s Hangzhou Dianzi University has developed a printer called Regenovo, which printed a small working kidney that lasted four months.

“These initiatives are well-intentioned, but raise a number of questions that remain unanswered. What happens when complex enhanced organs involving nonhuman cells are made? Who will control the ability to produce them? Who will ensure the quality of the resulting organs?” Basiliere said.

Gartner believes demand for bio-printing will explode in 2015, due to a burgeoning population and insufficient levels of healthcare in emerging markets. “The overall success rates of 3D printing use cases in emerging regions will escalate for three main reasons: the increasing ease of access and commoditization of the technology; ROI; and because it simplifies supply chain issues with getting medical devices to these regions,” Basiliere said. “Other primary drivers are a large population base with inadequate access to healthcare in regions often marred by internal conflicts, wars or terrorism.”

It’s interesting to hear Gartner’s bold predictions for bio-printing. Some of the experts we have talked to seem to think bio-printing is further off than many expect, possibly even 20 or 30 years away for fully functioning organs used in transplants on humans. However, less complicated bio-printing procedures and tissue is only a few years away.

 

FDA examining regulations for 3‑D printed medical devices

Renee Eaton Monday, October 27, 2014

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The official purpose of a recent FDA-sponsored workshop was “to provide a forum for FDA, medical device manufacturers, additive manufacturing companies and academia to discuss technical challenges and solutions of 3-D printing.” The FDA wants “input to help it determine technical assessments that should be considered for additively manufactured devices to provide a transparent evaluation process for future submissions.”

Simply put, the FDA is trying to stay current with advanced manufacturing technologies that are revolutionizing patient care and, in some cases, democratizing its availability. When a next-door neighbor can print a medical device in his or her basement, it clearly has many positive and negative implications that need to be considered.

Ignoring the regulatory implications for a moment, the presentations at the workshop were fascinating.

STERIS representative Dr. Bill Brodbeck cautioned that the complex designs and materials now being created with additive manufacturing make sterilization practices challenging. For example, how will the manufacturer know if the implant is sterile or if the agent has been adequately removed? Also, some materials and designs cannot tolerate acids, heat or pressure, making sterilization more difficult.

Dr. Thomas Boland from the University of Texas at El Paso shared his team’s work on 3-D-printed tissues. Using inkjet technology, the researchers are evaluating the variables involved in successfully printing skin. Another bio-printing project being undertaken at Wake Forest by Dr. James Yoo involves constructing bladder-shaped prints using bladder cell biopsies and scaffolding.

Dr. Peter Liacouras at Walter Reed discussed his institution’s practice of using 3-D printing to create surgical guides and custom implants. In another biomedical project, work done at Children’s National Hospital by Drs. Axel Krieger and Laura Olivieri involves the physicians using printed cardiac models to “inform clinical decisions,” i.e. evaluate conditions, plan surgeries and reduce operating time.

As interesting as the presentations were, the subsequent discussions were arguably more important. In an attempt to identify and address all significant impacts of additive manufacturing on medical device production, the subject was organized into preprinting (input), printing (process) and post-printing (output) considerations. Panelists and other stakeholders shared their concerns and viewpoints on each topic in an attempt to inform and persuade FDA decision-makers.

An interesting (but expected) outcome was the relative positions of the various stakeholders. Well-established and large manufacturers proposed validation procedures: material testing, process operating guidelines, quality control, traceability programs, etc. Independent makers argued that this approach would impede, if not eliminate, their ability to provide low-cost prosthetic devices.

Comparing practices to the highly regulated food industry, one can understand and accept the need to adopt similar measures for some additively manufactured medical devices. An implant is going into someone’s body, so the manufacturer needs to evaluate and assure the quality of raw materials, processing procedures and finished product.

But, as in the food industry, this means the producer needs to know the composition of materials. Suppliers cannot hide behind proprietary formulations. If manufacturers are expected to certify that a device is safe, they need to know what ingredients are in the materials they are using.

Many in the industry are also lobbying the FDA to agree that manufacturers should be expected to certify the components and not the additive manufacturing process itself. They argue that what matters is whether the device is safe, not what process was used to make it.

Another distinction should be the product’s risk level. Devices should continue to be classified as I, II or III and that classification, not the process used, should determine its level of regulation.

 

 

Will the FDA Regulate Bioprinting?

Published by Sandra Helsel, May 21, 2014 10:20 am

(3DPrintingChannel) The FDA currently assesses 3D printed medical devices and conventionally made products under the same guidelines, despite the different manufacturing methods involved. To receive device approval, manufacturers must prove that the device is equivalent to a product already on the market for the same use, or the device must undergo the process of attaining pre-market approval. However, the approval process for 3D printed devices could become complicated because the devices are manufactured differently and can be customizable. Two teams at the agency are now trying to determine how approval process should be tweaked to account for the changes.

3D Printing and 3D Bioprinting – Will the FDA Regulate Bioprinting?

This entry was posted by Bill Decker on May 20, 2014 at 8:52 am

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VIEW VIDEO

https://www.youtube.com/watch?v=5KY-JZCXKXQ#action=share

 

The 3d printing revolution came to medicine and is making people happy while scaring them at the same time!

3-D printing—the process of making a solid object of any shape from a digital model—has grown increasingly common in recent years, allowing doctors to craft customized devices like hearing aids, dental implants, and surgical instruments. For example, University of Michigan researchers last year used a 3-D laser printer to create an airway splint out of plastic particles. In another case, a patient had 75% of his skull replaced with a 3-D printed implant customized to fit his head. The 3d printing revolution came to medicine and is making people happy while scaring them at the same time!

Printed hearts? Doctors are getting there
FDA currently treats assesses 3-D printed medical devices and conventionally made products under the same guidelines, despite the different manufacturing methods involved. To receive device approval, manufacturers must prove that the device is equivalent to a product already on the market for the same use, or the device must undergo the process of attaining pre-market approval.

“We evaluate all devices, including any that utilize 3-D printing technology, for safety and effectiveness, and appropriate benefit and risk determination, regardless of the manufacturing technologies used,” FDA spokesperson Susan Laine said.
However, the approval process for 3-D printed devices could become complicated because the devices are manufactured differently and can be customizable. Two teams at the agency now are trying to determine how approval process should be tweaked to account for the changes:

http://product-liability.weil.com/news/the-stuff-of-innovation-3d-bioprinting-and-fdas-possible-reorganization/

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The Stuff of Innovation – 3D Bioprinting and FDA’s Possible Reorganization

Weil Product Liability Monitor on September 10, 2013 ·

Posted in News

Contributing Author: Meghan A. McCaffrey

With 3D printers, what used to exist only in the realm of science fiction — who doesn’t remember the Star Trek food replicator that could materialize a drink or meal with the mere press of a button — is now becoming more widely available with  food on demand, prosthetic devices, tracheal splintsskull implants, and even liver tissue all having recently been printed, used, implanted or consumed.  3D printing, while exciting, also presents a unique hybrid of technology and biology, making it a potentially unique and difficult area to regulate and oversee.  With all of the recent technological advances surround 3D printer technology, the FDA recently announced in a blog post that it too was going 3D, using it to “expand our research efforts and expand our capabilities to review innovative medical products.”  In addition, the agency will be investigating how 3D printing technology impacts medical devices and manufacturing processes.  This will, in turn, raise the additional question of how such technology — one of the goals of which, at least in the medical world,  is to create unique and custom printed devices, tissue and other living organs for use in medical procedures — can be properly evaluated, regulated and monitored.
In medicine, 3D printing is known as “bioprinting,” where so-called bioprinters print cells in liquid or gel format in an attempt to engineer cartilage, bone, skin, blood vessels, and even small pieces of liver and other human tissues [see a recent New York Times article here].  Not to overstate the obvious, but this is truly cutting edge science that could have significant health and safety ramifications for end users.  And more importantly for regulatory purposes, such bioprinting does not fit within the traditional category of a “device” or a “biologic.”  As was noted in Forbes, “more of the products that FDA is tasked with regulating don’t fit into the traditional categories in which FDA has historically divided its work.  Many new medical products transcend boundaries between drugs, devices, and biologics…In such a world, the boundaries between FDA’s different centers may no longer make as much sense.”  To that end, Forbes reported that FDA Commissioner Peggy Hamburg announced Friday the formation of a “Program Alignment Group” at the FDA whose goal is to identify and develop plans “to best adapt to the ongoing rapid changes in the regulatory environment, driven by scientific innovation, globalization, the increasing complexity of regulated products, new legal authorities and additional user fee programs.”

It will be interesting to see if the FDA can retool the agency to make it a more flexible, responsive, and function-specific organization.  In the short term, the FDA has tasked two laboratories in the Office of Science and Engineering Laboratories with investigating how the new 3D technology can impact the safety and efficacy of devices and materials manufactured using the technology.  The Functional Performance and Device Use Laboratory is evaluating “the effect of design changes on the safety and performance of devices when used in different patient populations” while the Laboratory for Solid Mechanics is assessing “how different printing techniques and processes affect the strength and durability of the materials used in medical devices.”  Presumably, all of this information will help the FDA evaluate at some point in the future whether a 3D printed heart is safe and effective for use in the patient population.

In any case, this type of hybrid technology can present a risk for companies and manufacturers creating and using such devices.  It remains to be seen what sort of regulations will be put in place to determine, for example, what types of clinical trials and information will have to be provided before a 3D printer capable of printing a human heart is approved for use by the FDA.  Or even on a different scale, what regulatory hurdles (and on-going monitoring, reporting, and studies) will be required before bioprinted cartilage can be implanted in a patient’s knee.  Are food replicators and holodecks far behind?

http://www.raps.org/regulatory-focus/news/2014/05/19000/FDA-3D-Printing-Guidance-and-Meeting/

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FDA Plans Meeting to Explore Regulation, Medical Uses of 3D Printing Technology

Posted 16 May 2014 By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) plans to soon hold a meeting to discuss the future of regulating medical products made using 3D printing techniques, it has announced.

fdaplanstomeetbioprinting

Background

3D printing is a manufacturing process which layers printed materials on top of one another, creating three-dimensional parts (as opposed to injection molding or routing materials).

The manufacturing method has recently come into vogue with hobbyists, who have been driven by several factors only likely to accelerate in the near future:

  • The cost of 3D printers has come down considerably.
  • Electronic files which automate the printing process are shareable over the Internet, allowing anyone with the sufficient raw materials to build a part.
  • The technology behind 3D printing is becoming more advanced, allowing for the manufacture of increasingly durable parts.

While the technology has some alarming components—the manufacture of untraceable weapons, for example—it’s increasingly being looked at as the future source of medical product innovation, and in particular for medical devices like prosthetics.

Promise and Problems

But while 3D printing holds promise for patients, it poses immense challenges for regulators, who must assess how to—or whether to—regulate the burgeoning sector.

In a recent FDA Voice blog posting, FDA regulators noted that 3D-printed medical devices have already been used in FDA-cleared clinical interventions, and that it expects more devices to emerge in the future.

Already, FDA’s Office of Science and Engineering laboratories are working to investigate how the technology will affect the future of device manufacturing, and CDRH’s Functional Performance and Device Use Laboratory is developing and adapting computer modeling methods to help determine how small design changes could affect the safety of a device. And at the Laboratory for Solid Mechanics, FDA said it is investigating the materials used in the printing process and how those might affect durability and strength of building materials.

And as Focus noted in August 2013, there are myriad regulatory challenges to confront as well. For example: If a 3D printer makes a medical device, will that device be considered adulterated since it was not manufactured under Quality System Regulation-compliant conditions? Would each device be required to be registered with FDA? And would FDA treat shared design files as unauthorized promotion if they failed to make proper note of the device’s benefits and risks? What happens if a device was never cleared or approved by FDA?

The difficulties for FDA are seemingly endless.

Plans for a Guidance Document

But there have been indications that FDA has been thinking about this issue extensively.

In September 2013, Focus first reported that CDRH Director Jeffery Shuren was planning to release a guidance on 3D printing in “less than two years.”

Responding to Focus, Shuren said the guidance would be primarily focused on the “manufacturing side,” and probably on how 3D printing occurs and the materials used rather than some of the loftier questions posed above.

“What you’re making, and how you’re making it, may have implications for how safe and effective that device is,” he said, explaining how various methods of building materials can lead to various weaknesses or problems.

“Those are the kinds of things we’re working through. ‘What are the considerations to take into account?'”

“We’re not looking to get in the way of 3D printing,” Shuren continued, noting the parallel between 3D printing and personalized medicine. “We’d love to see that.”

Guidance Coming ‘Soon’

In recent weeks there have been indications that the guidance could soon see a public release. Plastics News reported that CDRH’s Benita Dair, deputy director of the Division of Chemistry and Materials Science, said the 3D printing guidance would be announced “soon.”

“In terms of 3-D printing, I think we will soon put out a communication to the public about FDA’s thoughts,” Dair said, according to Plastics News. “We hope to help the market bring new devices to patients and bring them to the United States first. And we hope to play an integral part in that.”

Public Meeting

But FDA has now announced that it may be awaiting public input before it puts out that guidance document. In a 16 May 2014 Federal Register announcement, the agency said it will hold a meeting in October 2014 on the “technical considerations of 3D printing.”

“The purpose of this workshop is to provide a forum for FDA, medical device manufacturers, additive manufacturing companies, and academia to discuss technical challenges and solutions of 3-D printing. The Agency would like input regarding technical assessments that should be considered for additively manufactured devices to provide a transparent evaluation process for future submissions.”

That language—”transparent evaluation process for future submissions”—indicates that at least one level, FDA plans to treat 3D printing no differently than any other medical device, subjecting the products to the same rigorous premarket assessments that many devices now undergo.

FDA’s notice seems to focus on industrial applications for the technology—not individual ones. The agency notes that it has already “begun to receive submissions using additive manufacturing for both traditional and patient-matched devices,” and says it sees “many more on the horizon.”

Among FDA’s chief concerns, it said, are process verification and validation, which are both key parts of the medical device quality manufacturing regulations.

But the notice also indicates that existing guidance documents, such as those specific to medical device types, will still be in effect regardless of the 3D printing guidance.

Discussion Points

FDA’s proposed list of discussion topics include:

  • Preprinting considerations, including but not limited to:
    • material chemistry
    • physical properties
    • recyclability
    • part reproducibility
    • process validation
  • Printing considerations, including but not limited to:
    • printing process characterization
    • software used in the process
    • post-processing steps (hot isostatic pressing, curing)
    • additional machining
  • Post-printing considerations, including but not limited to:
    • cleaning/excess material removal
    • effect of complexity on sterilization and biocompatibility
    • final device mechanics
    • design envelope
    • verification

– See more at: http://www.raps.org/regulatory-focus/news/2014/05/19000/FDA-3D-Printing-Guidance-and-Meeting/#sthash.cDg4Utln.dpuf

 

FDA examining regulations for 3‑D printed medical devices

 

Renee Eaton Monday, October 27, 2014

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The official purpose of a recent FDA-sponsored workshop was “to provide a forum for FDA, medical device manufacturers, additive manufacturing companies and academia to discuss technical challenges and solutions of 3-D printing.” The FDA wants “input to help it determine technical assessments that should be considered for additively manufactured devices to provide a transparent evaluation process for future submissions.”

Simply put, the FDA is trying to stay current with advanced manufacturing technologies that are revolutionizing patient care and, in some cases, democratizing its availability. When a next-door neighbor can print a medical device in his or her basement, it clearly has many positive and negative implications that need to be considered.

Ignoring the regulatory implications for a moment, the presentations at the workshop were fascinating.

STERIS representative Dr. Bill Brodbeck cautioned that the complex designs and materials now being created with additive manufacturing make sterilization practices challenging. For example, how will the manufacturer know if the implant is sterile or if the agent has been adequately removed? Also, some materials and designs cannot tolerate acids, heat or pressure, making sterilization more difficult.

Dr. Thomas Boland from the University of Texas at El Paso shared his team’s work on 3-D-printed tissues. Using inkjet technology, the researchers are evaluating the variables involved in successfully printing skin. Another bio-printing project being undertaken at Wake Forest by Dr. James Yoo involves constructing bladder-shaped prints using bladder cell biopsies and scaffolding.

Dr. Peter Liacouras at Walter Reed discussed his institution’s practice of using 3-D printing to create surgical guides and custom implants. In another biomedical project, work done at Children’s National Hospital by Drs. Axel Krieger and Laura Olivieri involves the physicians using printed cardiac models to “inform clinical decisions,” i.e. evaluate conditions, plan surgeries and reduce operating time.

As interesting as the presentations were, the subsequent discussions were arguably more important. In an attempt to identify and address all significant impacts of additive manufacturing on medical device production, the subject was organized into preprinting (input), printing (process) and post-printing (output) considerations. Panelists and other stakeholders shared their concerns and viewpoints on each topic in an attempt to inform and persuade FDA decision-makers.

An interesting (but expected) outcome was the relative positions of the various stakeholders. Well-established and large manufacturers proposed validation procedures: material testing, process operating guidelines, quality control, traceability programs, etc. Independent makers argued that this approach would impede, if not eliminate, their ability to provide low-cost prosthetic devices.

Comparing practices to the highly regulated food industry, one can understand and accept the need to adopt similar measures for some additively manufactured medical devices. An implant is going into someone’s body, so the manufacturer needs to evaluate and assure the quality of raw materials, processing procedures and finished product.

But, as in the food industry, this means the producer needs to know the composition of materials. Suppliers cannot hide behind proprietary formulations. If manufacturers are expected to certify that a device is safe, they need to know what ingredients are in the materials they are using.

Many in the industry are also lobbying the FDA to agree that manufacturers should be expected to certify the components and not the additive manufacturing process itself. They argue that what matters is whether the device is safe, not what process was used to make it.

Another distinction should be the product’s risk level. Devices should continue to be classified as I, II or III and that classification, not the process used, should determine its level of regulation.

If you are interested in submitting comments to the FDA on this topic, post them by Nov. 10.

FDA Guidance Summary on 3D BioPrinting

fdaregulationguidelinesfor3dbioprinting_1 fdaregulationguidelinesfor3dbioprinting_2 fdaregulationguidelinesfor3dbioprinting_3 fdaregulationguidelinesfor3dbioprinting_4 fdaregulationguidelinesfor3dbioprinting_5 fdaregulationguidelinesfor3dbioprinting_6 fdaregulationguidelinesfor3dbioprinting_7 fdaregulationguidelinesfor3dbioprinting_8 fdaregulationguidelinesfor3dbioprinting_9 fdaregulationguidelinesfor3dbioprinting_10 fdaregulationguidelinesfor3dbioprinting_11

 

 

 

 

 

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Bio-inks and 3D BioPrinting

Curator: Stephen J. Williams, Ph.D.

 

Bio-ink is a material made from living cells that behaves much like a liquid, allowing people to “print” it in order to create a desired shape. This material was developed by researchers at the University of Missouri, Columbia, with the goal of someday being able to do things like print replacements for failing organs. This technology is only in the very early stages of testing and development, but it shows promise.

To make bio-ink, scientists create a slurry of cells that can be loaded into a cartridge and inserted into a specially designed printer, along with another cartridge containing a gel known as bio-paper. After inputting the standards for the thing they want to print, the researchers trigger the printer, and the cartridges alternate layers to build a three dimensional structure, with the bio-paper creating a supportive matrix that the ink can thrive on.

Through a process that is not yet totally understood, the individual droplets fuse together, eventually latticing upwards through the bio-paper to create a solid structure. Understanding this process and the point at which cells differentiate to accomplish different tasks is an important part of creating a usable material; perhaps someday hospitals will be able to use it to generate tissue and organs for use by their patients.

 

The most obvious potential use for bio-ink is in skin grafting. With this technology, labs could quickly create sheets of skin for burn victims and other people who might be in need of grafts. By creating grafts derived from the patient’s own cells, it could reduce the risk of rejection and scarring. Bio-ink could also be used to make replacements for vascular material removed during surgeries, allowing people to receive new veins and arteries.

Eventually, entire organs could be constructed from this material. Since organs are in short supply around the world, bio-ink could potentially save untold numbers of lives, as patients would no longer have to wait on the transplant list for new organs. The use of such organs could also allay fears about contaminated organ supplies or unscrupulous organ acquisition methods.

 

RegenHu

Universal Matrix for 3D Tissue Printing

BioInkTM is a chemically-defined hydrogel to support growth of different cell types. It allows cell adhesion, mimics the natural extracellular matrix and is biodegradable.

BioInkTM is provided as a ready-to-use chemically-defined hydrogel to print 3D tissue models. Exclusively designed for regenHU’s BioFactory® and 3DDiscovery® tissue and bio-printers.

A versatile, chemically-defined hydrogel, supporting cell attachment, growth, differentiation and migration. The BioInkTM is suitable for long-term tissue cultivation (in vitro human dermis for up to 7 weeks).

 

 

 

 

 

 

 

A versatile bioink for three-dimensional printing of cellular scaffolds based on thermally and photo-triggered tandem gelation

  • a Cartilage Engineering + Regeneration Laboratory, ETH Zürich, Otto-Stern-Weg 7, 8093 Zürich, Switzerland
  • b Biomaterials Department, INNOVENT e.V. Jena, Prüssingstrasse 27 B, 07745 Jena, Germany
  • c AO Research Institute Davos, Clavadelerstrasse 8, 7270 Davos Platz, Switzerland

 

Layer-by-layer bioprinting is a logical choice for the fabrication of stratified tissues like articular cartilage. Printing of viable organ replacements, however, is dependent on bioinks with appropriate rheological and cytocompatible properties. In cartilage engineering, photocrosslinkable glycosaminoglycan-based hydrogels are chondrogenic, but alone have generally poor printing properties. By blending the thermoresponsive polymer poly(N-isopropylacrylamide) grafted hyaluronan (HA-pNIPAAM) with methacrylated hyaluronan (HAMA), high-resolution scaffolds with good viability were printed. HA-pNIPAAM provided fast gelation and immediate post-printing structural fidelity, while HAMA ensured long-term mechanical stability upon photocrosslinking. The bioink was evaluated for rheological properties, swelling behavior, printability and biocompatibility of encapsulated bovine chondrocytes. Elution of HA-pNIPAAM from the scaffold was necessary to obtain good viability. HA-pNIPAAM can therefore be used to support extrusion of a range of biopolymers which undergo tandem gelation, thereby facilitating the printing of cell-laden, stratified cartilage constructs with zonally varying composition and stiffness.

bioink presentation_1 bioink presentation_2 bioink presentation_3 bioink presentation_4 bioink presentation_5 bioink presentation_6 bioink presentation_7 bioink presentation_8 bioink presentation_9 bioink presentation_10 bioink presentation_11 bioink presentation_12 bioink presentation_13 bioink presentation_14 bioink presentation_15

 

https://www.youtube.com/watch?v=9D749wZSlb0

For more information see:

http://www.slideshare.net/StephenJWilliamsPhD/clipboards/my-clips

 

And for more information on biopaper and methodology please see this pdf file courtesy of The First Symposium on BioPrinting in Tissue Engineering (see file) biopaper presentation

 

 

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Lab Grown Brains and more from Twittersphere on 3D Bio-Printing News

Curator: Stephen J. Williams, Ph.D

How Tiny Lab-Grown Human Brains Are Giving Big Insights Into Autism and more from the Twittershpere

 

https://twitter.com/singularityhub/status/664508353771610112

(more…)

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3-D Printed Liver

Larry H. Bernstein, MD, FCAP, Curator

LPBI

 

This is an interesting topic.  We already have liver transplantation.  When the procedure was introduced, a liver transplant could deplete the blood supply in a small state.  Kidney transplantation did not pose that problem, and we are now much beyond classic dialysis with intraperitoneal dialysis at home on a daily basis.   Liver transplantation raises issues about who receives the benefit.  Alcoholism is self destructive, but undoubtedly they are among the recipients.  Hepatocarcinoma is uncommon, and it has a poor prognosis.  Patients who have a transthyretin gene mutant associated with neurodegeneration who are likely to have a family history descending from Portugal, Sweden, Brazil, and a locality in Japan are receiving liver transplants.  The 3-D bioprint model would clearly apply. It becomes of great interest in those who have received blood transfusions or have become infected with HCV.

 

3D Printed Liver Models Save Lives at Cleveland Clinic

Currently, 3D printing models of patients’ organs is becoming a pretty common and easy practice that is being used in an increasing variety of surgeries. At the time, however, it was still very experimental and required a lot of testing.

“We went through a process for every patient who underwent liver surgery where we resected a portion of the liver, took it out, [and] prior to surgery, we prepared a 3D printed version of it,” said Dr. Zein

Dr. Zein believes that the 2012 trials resulted in the first-ever 3D printed liver. At that time, it took six weeks to print, which seems incredible when you consider how fast 3D printers are today, only three years later. Now, the hospital can print a replica liver in less than 48 hours. As 3D printing technology has improved, so have the models the hospital is able to print. The early models were yellowish and hazy, but now they are as clear as glass, enabling doctors to easily see blood vessels and bile ducts. In 2014, the hospital was using the models regularly during surgeries, and they’ve continued to improve. Different components can be printed individually, removed from the model for closer examination, and then replaced within the larger organ model using a series of magnets. At this point, Zein has printed over 20 liver models.

Having perfected the method of 3D liver modeling, the clinic was able to offer hope to a patient with a liver tumor who had already been turned down by other hospitals. Dr. Zein is thrilled with the possibilities that 3D printing offers for saving lives that could not have been saved before.

“My career has been as a clinical investigator so medical research and investigation is part of my life and it’s probably the most exciting part of my life,” he said. “So I’m very proud of what we did. What comes out of it, in the end, I’m not sure, but I have a feeling that there will be a role for these technologies, 3D printing, in complex surgeries.”

 

Researchers 3D Print Artificial Liver-like Device to Detoxify The Blood

Nanoengineers at the University of California, San Diego have been taking a different approach to creating a liver, an artificial one. They have been successful in creating a device which functions in a similar manner as the human organ, but is designed to be used outside the body, sort of like dialysis.

Recently engineers have used nanoparticles, tiny particles which are between 1 and 100 nanometers in size, to neutralize pore-forming toxins in the blood. These toxins can either be released by bacteria during an infection, or by insect or snake venom after a bite or sting. The toxins are released into the bloodstream, causing illness, or even death by destroying cells.  They do this by basically poking holes in the cell membranes. The method developed to neutralize the toxins has been heralded as a success, however there is a major risk of secondary poisoning, which can come about when the nanoparticles enter the liver and accumulate.

liver-2

http://3dprint.com/wp-content/uploads/2014/05/liver-2.jpg

 

A team of researchers, led by nanoengineering professor Shaochen Chen, have come up with a solution. Their solution is a matrix, which they 3D print out of a hydrogel material. This matrix is used to house the nanoparticles, and neutralize any pore-forming toxins. This mimicks the functions of the human liver.

“The concept of using 3D printing to encapsulate functional nanoparticles in a biocompatible hydrogel is novel,” said Chen. “This will inspire many new designs for detoxification techniques since 3D printing allows user-specific or site-specific manufacturing of highly functional products.”

The bioprinting technology used by Chen and his team is called, dynamic optical projection stereolithography. Similar to the stereolithography technology used within the resin based 3D printer you may have at home, Chen’s printers use a liquid solution which contains cells as well as a photosensitive biopolymer. It then directs light towards the solution, which solidifies. Layer by layer, the printer gradually builds up the material until they have a finished structure. Chen has been developing this technology thanks to a grant of $1.5 million from the National Institute of Health.  Ultimately this technology could be used in a variety of important applications, producing various medical implants, devices, and human tissues.  Discuss this story at the forum thread at 3DPB.com related to Chen’s 3D printed liver-like device.

 

Professor Shaochen Chen

Professor Shaochen Chen

 

 

 

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FDA Guidance On Source Animal, Product, Preclinical and Clinical Issues Concerning the Use of Xenotranspantation Products in Humans – Implications for 3D BioPrinting of Regenerative Tissue

Reporter: Stephen J. Williams, Ph.D.

 

The FDA has submitted Final Guidance on use xeno-transplanted animal tissue, products, and cells into human and their use in medical procedures. Although the draft guidance was to expand on previous guidelines to prevent the introduction, transmission, and spread of communicable diseases, this updated draft may have implications for use of such tissue in the emerging medical 3D printing field.

This document is to provide guidance on the production, testing and evaluation of products intended for use in xenotransplantation. The guidance includes scientific questions that should be addressed by sponsors during protocol development and during the preparation of submissions to the Food and Drug Administration (FDA), e.g., Investigational New Drug Application (IND) and Biologics License Application (BLA). This guidance document finalizes the draft guidance of the same title dated February 2001.

For the purpose of this document, xenotransplantation refers to any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source, or (b) human body fluids, cells, tissues or organs that have had ex vivo contact with live nonhuman animal cells, tissues or organs. For the purpose of this document, xenotransplantation products include live cells, tissues or organs used in xenotransplantation. (See Definitions in section I.C.)

This document presents issues that should be considered in addressing the safety of viable materials obtained from animal sources and intended for clinical use in humans. The potential threat to both human and animal welfare from zoonotic or other infectious agents warrants careful characterization of animal sources of cells, tissues, and organs. This document addresses issues such as the characterization of source animals, source animal husbandry practices, characterization of xenotransplantation products, considerations for the xenotransplantation product manufacturing facility, appropriate preclinical models for xenotransplantation protocols, and monitoring of recipients of xenotransplantation products. This document recommends specific practices intended to prevent the introduction and spread of infectious agents of animal origin into the human population. FDA expects that new methods proposed by sponsors to address specific issues will be scientifically rigorous and that sufficient data will be presented to justify their use.

Examples of procedures involving xenotransplantation products include:

  • transplantation of xenogeneic hearts, kidneys, or pancreatic tissue to treat organ failure,
  • implantation of neural cells to ameliorate neurological degenerative diseases,
  • administration of human cells previously cultured ex vivo with live nonhuman animal antigen-presenting or feeder cells, and
  • extracorporeal perfusion of a patient’s blood or blood component perfused through an intact animal organ or isolated cells contained in a device to treat liver failure.

The guidance addresses issues such as:

  1. Clinical Protocol Review
  2. Xenotransplantation Site
  3. Criteria for Patient Selection
  4. Risk/Benefit Assessment
  5. Screening for Infectious Agents
  6. Patient Follow-up
  7. Archiving of Patient Plasma and Tissue Specimens
  8. Health Records and Data Management
  9. Informed Consent
  10. Responsibility of the Sponsor in Informing the Patient of New Scientific Information

A full copy of the PDF can be found below for reference:

fdaguidanceanimalsourcesxenotransplatntation

An example of the need for this guidance in conjunction with 3D printing technology can be understood from the below article (source http://www.geneticliteracyproject.org/2015/09/03/pig-us-xenotransplantation-new-age-chimeric-organs/)

Pig in us: Xenotransplantation and new age of chimeric organs

David Warmflash | September 3, 2015 | Genetic Literacy Project

Imagine stripping out the failing components of an old car — the engine, transmission, exhaust system and all of those parts — leaving just the old body and other structural elements. Replace those old mechanical parts with a brand new electric, hydrogen powered, biofuel, nuclear or whatever kind of engine you want and now you have a brand new car. It has an old frame, but that’s okay. The frame wasn’t causing the problem, and it can live on for years, undamaged.

When challenged to design internal organs, tissue engineers are taking a similar approach, particularly with the most complex organs, like the heart, liver and kidneys. These organs have three dimensional structures that are elaborate, not just at the gross anatomic level, but in microscopic anatomy too. Some day, their complex connective tissue scaffolding, the stroma, might be synthesized from the needed collagen proteins with advanced 3-D printing. But biomedical engineering is not there yet, so right now the best candidate for organ scaffolding comes from one of humanity’s favorite farm animals: the pig.

Chimera alarmists connecting with anti-biotechnology movements might cringe at the thought of building new human organs starting with pig tissue, but if you’re using only the organ scaffolding and building a working organ from there, pig organs may actually be more desirable than those donated by humans.

How big is the anti-chimerite movement?

Unlike anti-GMO and anti-vaccination activists, there really aren’t too many anti-chemerites around. Nevertheless, there is a presence on the web of people who express concern about mixing of humans and non-human animals. Presently, much of their concern is focussed on the growing of human organs inside non-human animals, pigs included. One anti-chemerite has written that it could be a problem for the following reason:

Once a human organ is grown inside a pig, that pig is no longer fully a pig. And without a doubt, that organ will no longer be a fully human organ after it is grown inside the pig. Those receiving those organs will be allowing human-animal hybrid organs to be implanted into them. Most people would be absolutely shocked to learn some of the things that are currently being done in the name of science.

The blog goes on to express alarm about the use of human genes in rice and from there morphs into an off the shelf garden variety anti-GMO tirade, though with an an anti-chemeric current running through it. The concern about making pigs a little bit human and humans a little bit pig becomes a concern about making rice a little bit human. But the concern about fusing tissues and genes of humans and other species does not fit with the trend in modern medicine.

Utilization of pig tissue enters a new age 

pigsinus

A porcine human ear for xenotransplantation. source: The Scientist

For decades, pig, bovine and other non-human tissues have been used in medicine. People are walking around with pig and cow heart valves. Diabetics used to get a lot of insulin from pigs and cows, although today, thanks to genetic engineering, they’re getting human insulin produced by microorganisms modified genetically to make human insulin, which is safer and more effective.

When it comes to building new organs from old ones, however, pig organs could actually be superior for a couple of reasons. For one thing, there’s no availability problem with pigs. Their hearts and other organs also have all of the crucial components of the extracellular matrix that makes up an organ’s scaffolding. But unlike human organs, the pig organs don’t tend to carry or transfer human diseases. That is a major advantage that makes them ideal starting material. Plus there is another advantage: typically, the hearts of human cadavers are damaged, either because heart disease is what killed the human owner or because resuscitation efforts aimed at restarting the heart of a dying person using electrical jolts and powerful drugs.

Rebuilding an old organ into a new one

How then does the process work? Whether starting with a donated human or pig organ, there are several possible methods. But what they all have in common is that only the scaffolding of the original organ is retained. Just like the engine and transmission of the old car, the working tissue is removed, usually using detergents. One promising technique that has been applied to engineer new hearts is being tested by researchers at the University of Pittsburgh. Detergents pumped into the aorta attached to a donated heart (donated by a human cadaver, or pig or cow). The pressure keeps the aortic valve closed, so the detergents to into the coronary arteries and through the myocardial (heart muscle) and endocardial (lining over the muscle inside the heart chambers) tissue, which thus gets dissolved over the course of days. What’s left is just the stroma tissue, forming a scaffold. But that scaffold has signaling factors that enable embryonic stem cells, or specially programed adult pleuripotent cells to become all of the needed cells for a new heart.

Eventually, 3-D printing technology may reach the point when no donated scaffolding is needed, but that’s not the case quite yet, plus with a pig scaffolding all of the needed signaling factors are there and they work just as well as those in a human heart scaffold. All of this can lead to a scenario, possibly very soon, in which organs are made using off-the-self scaffolding from pig organs, ready to produce a custom-made heart using stem or other cells donated by new organ’s recipient.

David Warmflash is an astrobiologist, physician, and science writer. Follow @CosmicEvolution to read what he is saying on Twitter.

And a Great Article in The Scientist by Dr. Ed Yong Entitled

Replacement Parts

To cope with a growing shortage of hearts, livers, and lungs suitable for transplant, some scientists are genetically engineering pigs, while others are growing organs in the lab.

By Ed Yong | August 1, 2012

Source: http://www.the-scientist.com/?articles.view/articleNo/32409/title/Replacement-Parts/

.. where Joseph Vacanti and David Cooper figured that using

“engineered pigs without the a-1,3-galactosyltransferase gene that produces the a-gal residues. In addition, the pigs carry human cell-membrane proteins such as CD55 and CD46 that prevent the host’s complement system from assembling and attacking the foreign cells”

thereby limiting rejection of the xenotransplated tissue.

In addition to issues related to animal virus transmission the issue of optimal scaffolds for organs as well as the advantages which 3D Printing would have in mass production of organs is discussed:

To Vacanti, artificial scaffolds are the future of organ engineering, and the only way in which organs for transplantation could be mass-produced. “You should be able to make them on demand, with low-cost materials and manufacturing technologies,” he says. That is relatively simple for organs like tracheas or bladders, which are just hollow tubes or sacs. Even though it is far more difficult for the lung or liver, which have complicated structures, Vacanti thinks it will be possible to simulate their architecture with computer models, and fabricate them with modern printing technology. (See “3-D Printing,” The Scientist, July 2012.) “They obey very ordered rules, so you can reduce it down to a series of algorithms, which can help you design them,” he says. But Taylor says that even if the architecture is correct, the scaffold would still need to contain the right surface molecules to guide the growth of any added cells. “It seems a bit of an overkill when nature has already done the work for us,” she says.

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3-D Medical BioPrinting Overview

Curator: Larry H. Bernstein, MD, FCAP

 

 

Osteo3D Opens Marketplace for 3D Printable Medical Models from Real Patient Data   

 BY ON FRI, JULY 24, 2015

 

There are many companies dedicated to improving the use of 3D printing in the medical sector, and one of them Osteo3D, just released an amazing online repository of medical 3D models. Of course, patient information is private, so some of the “live models” have been made anonymous.  But there are now over 100 3D models available to doctors and other registered medical professionals online, which allows them t0 compare their own patient’s 3D files with Osteo3D models.  In fact, they can 3D print these models at home or wherever they have access to a 3D printer.

But, if a doctor or medical student doesn’t have a 3D printer, they can order a print directly from Osteo3D.  The online platform is powered by cloud printing site df3d and is meant to increase awareness of the usefulness of 3D printing among healthcare professionals.  Osteo3D hopes that, by collaborating with healthcare professionals, the tech industry, and academic institutions, they will help facilitate access and lower costs for the use of 3D printing in the healthcare field.

Currently the models are divided into the following categories:

  • Head and neck
  • Spine
  • Chest
  • Abdomen and pelvis
  • Extremities

When you click on 3D view, you don’t get quite the same level of control and depth asSketchfab, and some of the models look like pixels are growing out of them, but I didn’t pay to download any of the models, so I can’t say for sure. They are currently on the lookout for 3D printing partners who can help them deliver these 3D prints from their cloud platform to their customers around the world.

 

Osteo3d-Models-Store-3d-printing-Medical-Models-Banner02

http://3dprintingindustry.com/wp-content/uploads/2015/07/Osteo3d-Models-Store-3d-printing-Medical-Models-Banner02-1024×337.jpg

 

We’ve covered a number of stories that revolve around the combination of scanning/sensing technologies, great 3D modeling software, and 3D printing.  This combination has arguably had the most impact on the quality of human life as it is seen in the medical sector.  Diagnoses are made to a patient with a life-threatening condition.  Doctors, then, use 3D scanning technology to capture the reality data of a patient’s affected area, whether it be an organ, vasculature, bone structure, or combination of all three.  Next, a 3D model is created and manipulated using innovative software, and the model is 3D printed.  Surgery is practiced and visualized on the model, and then performed on the patient.  After doctors have all of this information, they use it to teach other doctors and nurse practitioners.  So, why not spread this wealth of information?  This is digital information, after all.  Any 3D model that is successfully used to print a 3D model of a diagnosed patient can be transferred anywhere, to anyone.

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